GELFOAM
Report
- Report Number
- 1810189-2018-00012
- Event Type
- Injury
- Date Received
- December 26, 2018
- Report Date
- October 5, 2018
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ATTACHMENT: [1810189-20181226144547 _LIT.PDF].
PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED.
PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED.
07FEB2019: PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(6). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTIO...
PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED...
(B)(6) 2019 : PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: 0009-0323-01. CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: 10300090323018 SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION
07FEB2019: PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(6). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION.
07FEB2019: PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTI.
PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER #: (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED.
PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. #: (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT. BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N= 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. KEYWORDS FOREIGN BODY. GRANULOMA. INTRACRANIAL TUMOR. TUMOR-LIKE LESION INTRODUCTION ALLERGIC HOST REACTION AGAINST FOREIGN MATERIAL IS A COMMON PHENOMENON AND REPRESENTS THE PATHOLOGICAL BASIS FOR MANY DISORDERS. IT OCCURS GENERALLY IN ORGANS WITH A DIRECT EXPOSITION TO THE EXTERNAL ENVIRONMENT LIKE SKIN, GASTROINTESTINAL TRACT, OR RESPIRATORY TRACT. FOREIGN BODY REACTION IN INTERNAL ORGANS OR THE INTRACRANIAL CAVITY, HOWEVER, IS RARE AND NECESSITATES A PRIOR TRAUMA OR SURGERY. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOPSITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-UM THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE.
EVENT VERBATIM [PREFERRED TERM] INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOPSITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: 10300090323018 SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON 29APR2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE. FOLLOW-UP (18JUN2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH" RADIO BUTTON CHECKED TO REPLACE "NEAR INCIDENT", ON THE EU/CA DEVICE INFORMATION PAGE., COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. THIS IS A DEVICE MALFUNCTION TO CAUSE SERIOUS INJURY IN THIS CASE.
EVENT VERBATIM [PREFERRED TERM] INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOPSITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON 29APR2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE., COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. THIS IS A DEVICE MALFUNCTION TO CAUSE SERIOUS INJURY IN THIS CASE.
EVENT VERBATIM [PREFERRED TERM] INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED, 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY.' THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE. ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS: THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTO DOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION: THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES: IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION: IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED. WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRR REPORTS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER SITE IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON 29APR2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE. FOLLOW-UP (18JUN2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: 'UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH' RADIO BUTTON CHECKED TO REPLACE 'NEAR INCIDENT",' ON THE EU/CA DEVICE INFORMATION PAGE. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "PRODUCT PROBLEM" CHECKED ON THE MEDWATCH INFORMATION PAGE. FOLLOW-UP (08OCT2019): THIS IS A LITERATURE REPORT FROM THE ACTA NEUROCHIRURGICA, 2018, VOL 160 (11); PP 2069-2075, ENTITLED INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION: REFERENCE VOLUME AND PAGES. FOLLOW-UP (15OCT2019): THIS IS FOLLOW-UP FROM THE PRODUCT QUALITY COMPLAINTS GROUP. IT WAS REPORTED THE SEVERITY OF HARM WAS S4, AS PREVIOUSLY REPORTED, AND THIS IS FINAL INVESTIGATION RESULT. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. THE RETURN SAMPLE WAS NOT AVAILABLE. THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT DEVELOPED AN INTRACRANIAL FOREIGN MATERIAL GRANULOMA AFTER GELFOAM WAS USED FOR EMBOLIZATION DURING AN INTRACRANIAL SURGERY. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. FOLLOW-UP (20NOV2019): THIS IS A FOLLOW-UP REPORT COMBINING INFORMATION FROM DUPLICATE REPORTS (B)(4). THE CURRENT AND ALL SUBSEQUENT FOLLOW-UP INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER (B)(4). THE NEW INFORMATION REPORTED FROM THE PRODUCT QUALITY COMPLAINTS GROUP INCLUDES: OUR ASSESSMENT OF THE DETAILS OF THE COMPLAINT AGAINST OUR MEDICAL DEVICE RISK FILE DETERMINED THAT THE SEVERITY OF THE REPORTED MALFUNCTION IS NOT PRESENT; THEREFORE, A WORST CASE SEVERITY RANKING OF S5 IS ASSIGNED. SUCH MATERIALS ARE USED TO SYNTHESIZE SOME SUBSTANCES USED IN INTRACRANIAL SURGERY LIKE GELFOAM OR MICROFIBRILLAR COLLAGEN. NEVERTHELESS, IN PREVIOUSLY REPORTED CASES AS WELL AS IN OUR SERIES A SYSTEMIC ALLERGIC REACTION OR A HISTORY OF ALLERGIC DISEASE, IN GENERAL, WAS NOT PRESENT., COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. THE FINAL PRODUCT QUALITY COMPLAINT INVESTIGATION RESULT SHOWS THERE IS NO DEVICE MALFUNCTION.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION] , . CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. INTRODUCTION: ALLERGIC HOST REACTION AGAINST FOREIGN MATERIAL IS A COMMON PHENOMENON AND REPRESENTS THE PATHOLOGICAL BASIS FOR MANY DISORDERS. IT OCCURS GENERALLY IN ORGANS WITH A DIRECT EXPOSITION TO THE EXTERNAL ENVIRONMENT LIKE SKIN, GASTROINTESTINAL TRACT, OR RESPIRATORY TRACT. FOREIGN BODY REACTION IN INTERNAL ORGANS OR THE INTRACRANIAL CAVITY, HOWEVER, IS RARE AND NECESSITATES A PRIOR TRAUMA OR SURGERY. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOPSITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTO DOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS: THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION. THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED. WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). DESCRIPTION OF COMPLAINT: SUCH MATERIALS ARE USED TO SYNTHESIZE SOME SUBSTANCES USED IN INTRACRANIAL SURGERY LIKE GELFOAM OR MICROFIBRILLAR COLLAGEN. NEVERTHELESS, IN PREVIOUSLY REPORTED CASES AS WELL AS IN OUR SERIES A SYSTEMIC ALLERGIC REACTION OR A HISTORY OF ALLERGIC DISEASE, IN GENERAL, WAS NOT PRESENT. SEE ATTACHED LITERATURE ARTICLE FOR FURTHER DETAILS. ADDITIONAL INFORMATION: (NAME REDACTED) ON (B)(6) 2018 14:32:49 THE COMPLAINT AND ITS CLASSIFICATION HAVE BEEN REVIEWED. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN ESCALATED TO PFIZER US SAFETY DUE TO A WORST CASE SEVERITY RANKING OF S5. (NAME REDACTED) ON (B)(6) 2018 12:40:45. PROCESSING COMPLAINT BASED ON QAEF RECEIVED FROM SAFETY. DUE DATE FOR INVESTIGATION RESULTS: 20JAN2019. SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. #: (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30 MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. ALL WEIGHT CHECKS WERE WITHIN ACCEPTABLE LIMITS. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS WAS COMPARED DURING FORMULATION TO THE IN-PROCESS MATERIAL USAGE REPORT TO ASSURE THAT THE CORRECT RAW MATERIALS AND AMOUNTS WERE USED IN THE MANUFACTURE OF THE LOT. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES, AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. IT IS IMPORTANT TO NOTE THAT THE WEIGHT OF THE POWDER IS NOT CHECKED DURING THESE AUDITS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. QO BATCH HISTORY REPORT: COMPLETE - ACCEPTABLE. PER REVIEW OF THE APRR REPORTS OVER THE EXPIRY INTERVAL REACHING BACK FROM THE RECEIPT OF THE COMPLIANT, THERE WERE NO BATCHES PRODUCED WITH ANALYTICAL TESTING RESULTS THAT WERE OUTSIDE OF REGISTERED SPECIFICATIONS PRIOR TO RELEASE. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NA TO RELATED., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS: THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTO DOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS: THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION: THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES: IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION: IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE A DEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON 29APR2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE. FOLLOW-UP (18JUN2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH" RADIO BUTTON CHECKED TO REPLACE "NEAR INCIDENT", ON THE EU/CA DEVICE INFORMATION PAGE. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "PRODUCT PROBLEM" CHECKED ON THE MEDWATCH INFORMATION PAGE., COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. THIS IS A DEVICE MALFUNCTION TO CAUSE SERIOUS INJURY IN THIS CASE.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY.' THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOPSITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON 29APR2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE. FOLLOW-UP (18JUN2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH" RADIO BUTTON CHECKED TO REPLACE "NEAR INCIDENT", ON THE EU/CA DEVICE INFORMATION PAGE. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "PRODUCT PROBLEM" CHECKED ON THE MEDWATCH INFORMATION PAGE. FOLLOW-UP (08OCT2019): THIS IS A LITERATURE REPORT FROM THE ACTA NEUROCHIRURGICA, 2018, VOL 160 (11); PP 2069-2075, ENTITLED INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION: REFERENCE VOLUME AND PAGES. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. THIS IS A DEVICE MALFUNCTION TO CAUSE SERIOUS INJURY IN THIS CASE.
EVENT VERBATIM [PREFERRED TERM] INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED, 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY.' THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE. ABSTRACT BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION: THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES: IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. FOLLOW-UP (B)(6) 2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRR REPORTS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER SITE IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (B)(6) 2019: FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (B)(6) 2019: NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON (B)(6) 2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE. FOLLOW-UP (B)(6) 2019: FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: 'UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH' RADIO BUTTON CHECKED TO REPLACE 'NEAR INCIDENT",' ON THE EU/CA DEVICE INFORMATION PAGE. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "PRODUCT PROBLEM" CHECKED ON THE MEDWATCH INFORMATION PAGE. FOLLOW-UP (B)(6) 2019: THIS IS A LITERATURE REPORT FROM THE ACTA NEUROCHIRURGICA, 2018, VOL 160 (11); PP 2069-2075, ENTITLED INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION: REFERENCE VOLUME AND PAGES. FOLLOW-UP (B)(6) 2019: THIS IS FOLLOW-UP FROM THE PRODUCT QUALITY COMPLAINTS GROUP. IT WAS REPORTED THE SEVERITY OF HARM WAS S4, AS PREVIOUSLY REPORTED, AND THIS IS FINAL INVESTIGATION RESULT. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. THE RETURN SAMPLE WAS NOT AVAILABLE. THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT DEVELOPED AN INTRACRANIAL FOREIGN MATERIAL GRANULOMA AFTER GELFOAM WAS USED FOR EMBOLIZATION DURING AN INTRACRANIAL SURGERY. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION., COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. THE FINAL PRODUCT QUALITY COMPLAINT INVESTIGATION RESULT SHOWS THERE IS NO DEVICE MALFUNCTION.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED, 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY.' THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE. ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N= 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODY REACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS: THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-UM THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS: THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION: THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES: IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION: IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED. WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE A DEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRR REPORTS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER SITE IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NOT APPLICABLE (N/A) TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: (B)(4). AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PQC REPORT RECEIVED ON 29APR2019 WAS REMOVED FROM NARRATIVE AS IT WAS NOT SPECIFIC TO THIS CASE, AND WAS PREVIOUSLY ADDED INTO THIS CASE BY ERROR. THIS CASE IS ASSESSED AS MALFUNCTION REPORTABLE. FOLLOW-UP (18JUN2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: 'UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH' RADIO BUTTON CHECKED TO REPLACE 'NEAR INCIDENT",' ON THE EU/CA DEVICE INFORMATION PAGE. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: "PRODUCT PROBLEM" CHECKED ON THE MEDWATCH INFORMATION PAGE. FOLLOW-UP (08OCT2019): THIS IS A LITERATURE REPORT FROM THE ACTA NEUROCHIRURGICA, 2018, VOL 160 (11); PP 2069-2075, ENTITLED INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION: REFERENCE VOLUME AND PAGES. FOLLOW-UP (15OCT2019): THIS IS FOLLOW-UP FROM THE PRODUCT QUALITY COMPLAINTS GROUP. IT WAS REPORTED THE SEVERITY OF HARM WAS S4, AS PREVIOUSLY REPORTED, AND THIS IS FINAL INVESTIGATION RESULT. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. THE RETURN SAMPLE WAS NOT AVAILABLE. THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT DEVELOPED AN INTRACRANIAL FOREIGN MATERIAL GRANULOMA AFTER GELFOAM WAS USED FOR EMBOLIZATION DURING AN INTRACRANIAL SURGERY. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. THE FINAL PRODUCT QUALITY COMPLAINT INVESTIGATION RESULT SHOWS THERE IS NO DEVICE MALFUNCTION.
EVENT VERBATIM [PREFERRED TERM] INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. INTRODUCTION ALLERGIC HOST REACTION AGAINST FOREIGN MATERIAL IS A COMMON PHENOMENON AND REPRESENTS THE PATHOLOGICAL BASIS FOR MANY DISORDERS. IT OCCURS GENERALLY IN ORGANS WITH A DIRECT EXPOSITION TO THE EXTERNAL ENVIRONMENT LIKE SKIN, GASTROINTESTINAL TRACT, OR RESPIRATORY TRACT. FOREIGN BODY REACTION IN INTERNAL ORGANS OR THE INTRACRANIAL CAVITY, HOWEVER, IS RARE AND NECESSITATES A PRIOR TRAUMA OR SURGERY. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOPSITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTODOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED.WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP ((B)(6)2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4) DESCRIPTION OF COMPLAINT: SUCH MATERIALS ARE USED TO SYNTHESIZE SOME SUBSTANCES USED IN INTRACRANIAL SURGERY LIKE GELFOAM OR MICROFIBRILLAR COLLAGEN. NEVERTHELESS, IN PREVIOUSLY REPORTED CASES AS WELL AS IN OUR SERIES A SYSTEMIC ALLERGIC REACTION OR A HISTORY OF ALLERGIC DISEASE, IN GENERAL, WAS NOT PRESENT. SEE ATTACHED LITERATURE ARTICLE FOR FURTHER DETAILS. ADDITIONAL INFORMATION: (NAME REDACTED) (B)(6)2018 14:32:49 THE COMPLAINT AND ITS CLASSIFICATION HAVE BEEN REVIEWED. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN ESCALATED TO PFIZER US SAFETY DUE TO A WORST CASE SEVERITY RANKING OF S5. (NAME REDACTED) (B)(6)2018 12:40:45 LITERATURE ARTICLE ATTACHED. PROCESSING COMPLAINT BASED ON QAEF RECEIVED FROM SAFETY. DUE DATE FOR INVESTIGATION RESULTS:(B)(6)2019 . SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. # (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30 MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. ALL WEIGHT CHECKS WERE WITHIN ACCEPTABLE LIMITS. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS WAS COMPARED DURING FORMULATION TO THE IN-PROCESS MATERIAL USAGE REPORT TO ASSURE THAT THE CORRECT RAW MATERIALS AND AMOUNTS WERE USED IN THE MANUFACTURE OF THE LOT. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES, AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. IT IS IMPORTANT TO NOTE THAT THE WEIGHT OF THE POWDER IS NOT CHECKED DURING THESE AUDITS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. QO BATCH HISTORY REPORT: COMPLETE - ACCEPTABLE. PER REVIEW OF THE APRR REPORTS OVER THE EXPIRY INTERVAL REACHING BACK FROM THE RECEIPT OF THE COMPLIANT, THERE WERE NO BATCHES PRODUCED WITH ANALYTICAL TESTING RESULTS THAT WERE OUTSIDE OF REGISTERED SPECIFICATIONS PRIOR TO RELEASE. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODY REACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTO DOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS: THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION. THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION: IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED. WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER #: (L63414). RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE: ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NA TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (29APR2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE SUSPICION OF A MALFUNCTION, AND THE ASSOCIATED SEVERITY IS UNKNOWN. IMPACT TO THE DEVICE: THE POSSIBILITY FOR AN ADVERSE EVENT. THE COMPLAINT IS AS FOLLOWS: "SWELLING IN THE BRAIN AROUND THE SPONGE." PCOM NUMBER: 2019-04-0027910-TY. HARM: UNKNOWN. HAZARD NUMBER: UNKNOWN. PREVIOUS MDR: 2018415098 MAY BE ASSOCIATED FOR INTRACRANIAL GRANULOMA. FOLLOW-UP (02MAY2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: IMPACT TO THE DEVICE. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. HAZARDOUS SITUATION (WORST CASE S4): GELFOAM DOES NOT RESORB AFTER IMPLANTING INTO THE PATIENT. HAZARD NUMBER: H03-01. PREVIOUS MDR: # MAY BE ASSOCIATED FOR PLACENTAL ACCRETA; # MAY BE ASSOCIATED FOR THE SPONGE NEEDING TO BE REMOVED; # MAY BE ASSOCIATED FOR THE SPONGE NEEDING TO BE REMOVED; # MAY BE ASSOCIATED FOR THE SPONGE NOT DISSOLVING OR ABSORBING; # MAY BE ASSOCIATED FOR INTER-CRANIAL GRANULOMAS., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A 61-YEAR-OLD FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. INTRODUCTION: ALLERGIC HOST REACTION AGAINST FOREIGN MATERIAL IS A COMMON PHENOMENON AND REPRESENTS THE PATHOLOGICAL BASIS FOR MANY DISORDERS. IT OCCURS GENERALLY IN ORGANS WITH A DIRECT EXPOSITION TO THE EXTERNAL ENVIRONMENT LIKE SKIN, GASTROINTESTINAL TRACT, OR RESPIRATORY TRACT. FOREIGN BODY REACTION IN INTERNAL ORGANS OR THE INTRACRANIAL CAVITY, HOWEVER, IS RARE AND NECESSITATES A PRIOR TRAUMA OR SURGERY. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODYREACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS: THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE (1) EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND (2) DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE (1) TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; (2) CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND (3) CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTO DOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS: THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION: THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED. WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE ADEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE. FOLLOW-UP (07FEB2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM THE PRODUCT QUALITY COMPLAINTS GROUP. PRODUCT DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; PRODUCT COUNTRY: USA; SAP/UNIQUE IDENTIFIER: (B)(4). CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; SUBCLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SAMPLE STATUS: NOT REQUESTED. LOT NUMBER: UNKNOWN. LOT NUMBER UNKNOWN REASON: NOT PROVIDED IN CORRESPONDENCE/EMAIL COMMUNICATION. UDI: (B)(4). SCOPE: ALL GELFOAM AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THERE WAS ONE PREVIOUSLY RECEIVED COMPLAINT WITH A KNOWN BATCH NUMBER. #: (L63414) RETURNED PRODUCT EXAMINATION: PGS (PLACE REDACTED) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. A REFERENCE SAMPLE EXAMINATION WAS PERFORMED FOR THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE EXAMINATION DETERMINED THAT THE AMOUNT AND APPEARANCE OF PRODUCT PRESENT WAS ACCEPTABLE, AND THAT NO QUALITY DEFECTS WERE OBSERVED IN THE COURSE OF THE EXAM. DEVIATIONS: COMPLETE - ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AS A PART OF THE COMPLAINT WITH A KNOWN BATCH NUMBER LISTED ABOVE. A REVIEW OF THE REPORT DETERMINED THAT THE MANUFACTURING RECORDS WERE ACCEPTABLE, AND THAT NO QUALITY ISSUES WERE PRESENT. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30 MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. ALL WEIGHT CHECKS WERE WITHIN ACCEPTABLE LIMITS. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS WAS COMPARED DURING FORMULATION TO THE IN-PROCESS MATERIAL USAGE REPORT TO ASSURE THAT THE CORRECT RAW MATERIALS AND AMOUNTS WERE USED IN THE MANUFACTURE OF THE LOT. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES, AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. IT IS IMPORTANT TO NOTE THAT THE WEIGHT OF THE POWDER IS NOT CHECKED DURING THESE AUDITS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. QO BATCH HISTORY REPORT: COMPLETE - ACCEPTABLE. PER REVIEW OF THE APRR REPORTS OVER THE EXPIRY INTERVAL REACHING BACK FROM THE RECEIPT OF THE COMPLIANT, THERE WERE NO BATCHES PRODUCED WITH ANALYTICAL TESTING RESULTS THAT WERE OUTSIDE OF REGISTERED SPECIFICATIONS PRIOR TO RELEASE. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'EXTERNAL CAUSE INVESTIGATION' WITH THE SUB-CLASSIFICATIONS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATION, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER (PLACE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (PLACE NAME) PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, EVALUATION OF TRENDS, AS WELL AS THE PREVIOUSLY INVESTIGATED COMPLAINT REPORT, INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY AS TO THE WORST CASE SEVERITY LEVEL FOR THE REPORTED MALFUNCTION AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT IS UNKNOWN. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (PLACE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. FURTHER ACTION BY PFIZER (PLACE NAME) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP IS TO UPDATE CAUSALITY FIELD FROM NA TO RELATED. FOLLOW-UP (15FEB2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (29APR2019): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDED: A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE SUSPICION OF A MALFUNCTION, AND THE ASSOCIATED SEVERITY IS UNKNOWN. IMPACT TO THE DEVICE: THE POSSIBILITY FOR AN ADVERSE EVENT. THE COMPLAINT VERBATIM IS AS FOLLOWS: "SWELLING IN THE BRAIN AROUND THE SPONGE." PCOM NUMBER: 2019-04-0027910-TY. HARM: UNKNOWN. HAZARD NUMBER: UNKNOWN. PREVIOUS MDR: 2018415098 MAY BE ASSOCIATED FOR INTRACRANIAL GRANULOMA., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
EVENT VERBATIM [PREFERRED TERM] INTRACRANIAL GRANULOMA [FOREIGN BODY REACTION]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL ACTA NEUROCHIRURGICA, 2018, ENTITLED 'INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY'. THIS REPORT INVOLVES PATIENT #11, A (B)(6) FEMALE WHO DEVELOPED INTRACEREBRAL FOREIGN BODY GRANULOMA WITH ABSORBABLE GELATIN (GELFOAM) 27 MONTHS AFTER RESECTION OF A METASTASIS IN THE FRONTAL LOBE (LUNG CARCINOMA). ABSTRACT: BACKGROUND VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT IN PLACE INTENTIONALLY DURING SURGERY FOR SEVERAL PURPOSES SUCH AS HEMOSTASIS, DURAL CLOSURE, OR CRANIOPLASTY. ALTHOUGH LEAVING SUCH SUBSTANCES IN SURGICAL SITES IS CONSIDERED SAFE, IN GENERAL, FOREIGN BODY GRANULOMA MAY OCCUR MONTHS OR YEARS AFTER INTRACRANIAL SURGERY. THUS, FAR RELATIVELY LITTLE IS KNOWN ABOUT TREATMENT AND OUTCOME OF SUCH LESIONS. METHODS: A SYSTEMATIC REVIEW OF 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES ACHIEVED OVER A 13-YEAR PERIOD WAS PERFORMED. AFTER EXCLUDING PATIENTS WITH TEFLON GRANULOMAS OR INFECTION, A TOTAL OF 12 PATIENTS WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT RECORDS, IMAGING STUDIES, AND HISTOPATHOLOGICAL DATA WERE ANALYZED. FURTHERMORE, POSTOPERATIVE OUTCOME WAS ASSESSED. RESULTS: MEAN AGE AT THE SECOND SURGERY WAS 51 YEARS (RANGE, 11-68 YEARS). THE MEDIAN TIME BETWEEN THE PRIMARY AND THE SECONDARY SURGERY WAS 13 MONTHS (RANGE, 1-545 MONTHS). EIGHT PATIENTS (75%) PRESENTED WITH SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS. TOTAL RESECTION OF THE FOREIGN BODY GRANULOMAS WAS PERFORMED IN ALL PATIENTS. THE GRANULOMAS WERE INDUCED BY OXIDIZED CELLULOSE POLYMER (N = 6), SUTURE MATERIAL (N = 3), GELFOAM (N = 1), METHYLMETHACRYLATE (N = 1), AND BONE WAX (N = 1). THE MEAN POSTOPERATIVE FOLLOW-UP TIME WAS 54 MONTHS (RANGE 1-137 MONTHS). THERE WAS SYMPTOMATIC IMPROVEMENT IN ALL INSTANCES. IMAGING STUDIES DID NOT DEMONSTRATE ANY RECURRENCE. CONCLUSION: DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY. THE PATHOGENESIS OF FOREIGN BODY GRANULOMA STILL NEEDS FURTHER CLARIFICATION. OUR STUDY DEMONSTRATES THAT THEY HAVE GOOD PROGNOSIS AFTER SURGICAL REMOVAL. KEYWORDS FOREIGN BODY. GRANULOMA. INTRACRANIAL TUMOR. TUMOR-LIKE LESION. INTRODUCTION ALLERGIC HOST REACTION AGAINST FOREIGN MATERIAL IS A COMMON PHENOMENON AND REPRESENTS THE PATHOLOGICAL BASIS FOR MANY DISORDERS. IT OCCURS GENERALLY IN ORGANS WITH A DIRECT EXPOSITION TO THE EXTERNAL ENVIRONMENT LIKE SKIN, GASTROINTESTINAL TRACT, OR RESPIRATORY TRACT. FOREIGN BODY REACTION IN INTERNAL ORGANS OR THE INTRACRANIAL CAVITY, HOWEVER, IS RARE AND NECESSITATES A PRIOR TRAUMA OR SURGERY. VARIOUS SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY AND LEFT INTENTIONALLY IN PLACE FOR SEVERAL PURPOSES, SUCH AS ACHIEVEMENT OF HEMOSTASIS, DURAL CLOSURE, MICROVASCULAR DECOMPRESSION, WRAPPING OF A CEREBRAL ANEURYSM, OR REPLACEMENT OF OSSEOUS DEFECTS OF THE SKULL. THESE AGENTS ARE PRINCIPALLY FOREIGN BODIES AND THEY MIGHT INDUCE A FOREIGN BODY REACTION RESULTING IN CHRONIC GRANULOMATOUS INFLAMMATION. FOREIGN BODY GRANULOMA WITH MASS EFFECT AFTER PRIOR SURGERY IS MOSTLY DESCRIBED IN GENERAL SURGERY USING TERMS LIKE GOSSYPIBOMA, GAUZOMA, AND MUSLINOMA. UNLIKE IN GENERAL SURGERY, IN WHICH THESE FOREIGN BODY REACTIONS OFTEN CONSTITUTE AN IATROGENIC MISTAKE, IN NEUROSURGERY FOREIGN BODY REACTIONS RATHER ARISE SECONDARY TO MATERIAL LEFT IN PLACE INTENTIONALLY. FOREIGN BODY GRANULOMAS WITH MASS EFFECT MAY APPEAR MONTHS OR YEARS AFTER PRIOR SURGERY AND THEY CAN SIMULATE TUMORS OR CEREBRAL ABSCESSES IN IMAGING STUDIES RESULTING IN A DIAGNOSTIC CHALLENGE FOR THE TREATING PHYSICIAN, ESPECIALLY WHEN A MISDIAGNOSIS MAY EXPOSE THE PATIENT TO AN UNNECESSARY TREATMENT LIKE RADIO AND/OR CHEMOTHERAPY. FURTHERMORE, FOREIGN BODY GRANULOMAS MAY CAUSE NEW SIGNS OR SYMPTOMS LIKE EPILEPSY, CRANIAL NERVE PALSY, EDEMA, HEMIPARESIS, OR HYDROCEPHALUS. POSTOPERATIVE INTRACRANIAL FOREIGN BODY GRANULOMAS HAVE BEEN DOCUMENTED IN CASE REPORTS AND SMALL SERIES OVER THE LAST 40 YEARS, HOWEVER, EXCEPT FOR TEFLON GRANULOMAS THE SIGNIFICANCE OF THIS CLINICAL ISSUE APPEARS TO BE UNDERESTIMATED AMONG NEUROSURGEONS. HERE, WE PRESENT A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED IN OUR CENTER OVER A PERIOD OF 13 YEARS. IN ALL PATIENTS, A SECOND SURGERY WAS PERFORMED TO REMOVE THE TUMOR-LIKE LESION AND ESTABLISHED THE DIAGNOSIS. ACCORDING TO OUR BEST KNOWLEDGE, THE PRESENT STUDY INVOLVES THE LARGEST SERIES REPORTED THUS FAR. MATERIAL AND METHODS THE ARCHIVES OF THE DEPARTMENT OF NEUROPATHOLOGY AT (HOSPITAL NAME) CONTAINING REPORTS ON 3466 HISTOPATHOLOGICAL EXAMINATIONS AFTER CRANIAL SURGERIES PERFORMED WITHIN A 13-YEAR PERIOD WERE SCREENED FOR A DIAGNOSIS OF FOREIGN BODY GRANULOMA. INCLUSION CRITERIA FOR THE PRESENT STUDY WERE EVIDENCE OF A HISTOPATHOLOGICAL DIAGNOSIS OF A CRANIAL FOREIGN BODY GRANULOMA AFTER PRIOR CRANIAL SURGERY AND DEMONSTRATION OF A TUMOR-LIKE LESION ON IMAGING STUDIES. EXCLUSION CRITERIA WERE TEFLOMA AFTER MICROVASCULAR DECOMPRESSION, AS PUBLISHED ELSEWHERE; CRANIAL FOREIGN BODY GRANULOMA WITH A CONCOMITANT INFECTION; AND CHOLESTEROL GRANULOMAS. ULTIMATELY, A TOTAL OF 12 PATIENTS FULFILLED THE INCLUSION CRITERIA. ALL RESECTED TISSUE WAS EXAMINED NEUROPATHOLOGICALLY. REPRESENTATIVE TISSUE WAS FIXED IN FORMALIN AND EMBEDDED IN PARAFFIN, CUT INTO 2-¿M THICK SECTIONS USING A MICROTOME AND THEN STAINED WITH H&E. THEN, THE SECTIONS WERE EVALUATED BY AN EXPERIENCED NEUROPATHOLOGIST AND INTERESTING AREAS WERE PHOTO DOCUMENTED. PATIENT RECORDS AND IMAGING STUDIES WERE REVIEWED AND ANALYZED. OUTCOME AND FOLLOW-UP DATA WERE REVIEWED AND SUPPLEMENTED WITH RECENT UPDATES WHEN NECESSARY. RESULTS THE STUDY CONSISTED OF 6 MEN AND 6 WOMEN. AGE AT THE TIME OF RESECTION OF THE FOREIGN BODY GRANULOMAS (SECOND SURGERY) IS RANGED BETWEEN 11 AND 68 YEARS (MEAN AGE 51 YEARS). THE PRIMARY SURGERIES WERE CRANIOTOMIES FOR REMOVAL OF INTRACRANIAL TUMORS (7 PATIENTS), EVACUATION OF INTRACEREBRAL HEMATOMAS (2 PATIENTS), TUMOR RESECTION AND CRANIOPLASTY WITH METHYLMETHACRYLATE (1 PATIENT), RESECTION OF AN ARTERIOVENOUS MALFORMATION (1 PATIENT), AND CLIPPING OF A CEREBRAL ANEURYSM (1 PATIENT). SIGNS AND SYMPTOMS ON PRESENTATION: THE MEDIAN TIME BETWEEN THE PRIMARY SURGERY AND THE DIAGNOSIS OF A FOREIGN BODY GRANULOMA WAS 13 MONTHS (SD ± 153, RANGE 1-545 MONTHS,). EIGHT PATIENTS (75%) HAD CLINICAL SIGNS AND SYMPTOMS RELATED TO THE FOREIGN BODY GRANULOMAS, WHILE THE OTHER 4 PATIENTS (25%) HAD NOT. IN THE ASYMPTOMATIC PATIENTS, THE CRANIAL LESIONS WERE DIAGNOSED INCIDENTALLY ON THE CONTROL FOLLOW-UP IMAGING STUDIES. FEVER WAS NOT RECORDED IN ANY INSTANCE. EXCEPT IN ONE PATIENT WITH ASSOCIATED ENDOCARDITIS, THE CRP VALUE, AND THE LEUKOCYTE COUNT WERE WITHIN NORMAL RANGE. CHARACTERISTICS OF THE FOREIGN BODY GRANULOMAS ON IMAGING STUDIES: IN TWO PATIENTS, BOTH CRANIAL MR AND CT IMAGING WERE PERFORMED PREOPERATIVELY. IN EIGHT PATIENTS, ONLY MR, AND IN THE OTHER 2 PATIENTS, ONLY CT WAS OBTAINED. IN THE TWO PATIENTS WHO HAD CT IMAGING ONLY, AN ABSCESS WAS SUSPECTED AND THEY WERE OPERATED IN AN EMERGENCY SETTING. THE MEAN DIAMETER OF THE FOREIGN BODY GRANULOMA WAS 2.9 CM (RANGE 1.5-4 CM). ALL GRANULOMAS ENHANCED WITH CONTRAST IN THE MRI OR THE CT IMAGING STUDIES, ENHANCEMENT WAS HETEROGENEOUS IN 5 PATIENTS, RING SHAPED IN 3 PATIENTS, AND HOMOGENOUS IN 4 PATIENTS. IN PATIENTS WITH EPIDURAL INVOLVEMENT, OSTEOLYSIS OF THE ADJACENT BONE WAS OBSERVED. TREATMENT AND RESULTS OF TISSUE EXAMINATION: IN ALL INSTANCES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. THERE WERE NO POSTOPERATIVE COMPLICATIONS. THE FOREIGN BODY GRANULOMAS WERE ASSOCIATED WITH OXIDIZED CELLULOSE POLYMER (TABOTAMP) IN 6 PATIENTS, SUTURE MATERIAL IN 3 PATIENTS, GELATIN FOAM (GELFOAM) IN 1 PATIENT, METHYLMETHACRYLATE (PALACOS) IN 1 PATIENT, AND BONE WAX IN 1 PATIENT. POSTOPERATIVE CARE AND FOLLOW-UP: THE MEAN FOLLOW-UP TIME AFTER RESECTION OF THE FOREIGN BODY GRANULOMA WAS 54 MONTHS (RANGE, 3-173 MONTHS). NO ADJUVANT TREATMENT WITH CORTICOSTEROIDS OR OTHER IMMUNOSUPPRESSIVE AGENTS WAS APPLIED. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DISCUSSION: IN OUR STUDY, THE FORMATION OF FOREIGN BODY GRANULOMA ASSOCIATED WITH ABSORBABLE MATERIAL LIKE OXIDIZED CELLULOSE, GENERALLY, OCCURRED IN THE FIRST YEAR AFTER THE INITIAL OPERATIVE PROCEDURE; WHEREAS, THE REACTION TO NON-ABSORBABLE MATERIAL SUCH AS METHYLMETHACRYLATE OR BONE WAX WAS OBSERVED DURING A MUCH LONGER TIME FRAME. THE PROGNOSIS OF INTRACRANIAL FOREIGN BODY GRANULOMA IS EXCELLENT WHEN DIAGNOSED APPROPRIATELY. ACCORDING TO OUR STUDY, POSTOPERATIVE TREATMENT IS NOT NECESSARY. ALL PATIENTS WITH PREOPERATIVE SYMPTOMS IMPROVED AFTER RESECTION OF THE FOREIGN BODY GRANULOMA AND FOLLOW-UP STUDIES SHOWED NO RECURRENCE OF THE INFLAMMATORY LESIONS. IT REMAINS, HOWEVER, TO BE DETERMINED WHEN A SURGERY SHOULD BE PERFORMED OR WHEN A WAIT-AND-SEE STRATEGY WITH IMAGING CONTROLS MAY BE ADOPTED. WE SUGGEST THAT SURGERY SHOULD BE PERFORMED IN SYMPTOMATIC PATIENTS AND IN PATIENTS WITH FOREIGN BODY GRANULOMAS RESULTING FROM NON-ABSORBABLE MATERIAL BECAUSE SPONTANEOUS HEALING IS NOT EXPECTED. FURTHERMORE, SURGERY IS INEVITABLE IN PATIENTS WITH SUSPECTED TUMOR RECURRENCE BOTH TO ACHIEVE A DEFINITE DIAGNOSIS AND TO PLAN FURTHER TREATMENT. IT REMAINS UNCLEAR, WHY FOREIGN BODY GRANULOMAS DEVELOP ONLY IN SUCH RARE INSTANCES IN THE INTRACRANIAL SURGERY. FURTHERMORE, THE QUESTION ARISES HOW SUCH FORMATIONS COULD BE PREVENTED IN THE FUTURE. CERTAINLY, CAREFUL AND THRIFTY USE OF SYNTHETIC MATERIAL MIGHT REDUCE FURTHER THE OCCURRENCE OF CLINICAL SIGNIFICANT FOREIGN MATERIAL GRANULOMAS. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: INTERVENTION REQUIRED ADDED AS ADDITIONAL SERIOUSNESS CRITERIA FOR THE EVENT OF INTRACRANIAL GRANULOMA. CASE COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THE PATIENT DEVELOPED INTRACRANIAL FOREIGN BODY GRANULOMA TWENTY SEVEN MONTHS FOLLOWING THE USE OF GELATIN FOAM DURING SURGERY FOR RESECTION OF A METASTASIS IN THE FRONTAL LOBE FOR LUNG CARCINOMA. DUE TO THE PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DEVELOPMENT OF A GIANT-CELL GRANULOMA AT THE IMPLANTATION SITE OF ABSORBABLE GELATIN PRODUCT IN THE BRAIN, THERE IS A POSSIBILITY THAT THE REPORTED SERIOUS EVENT OF INTRACRANIAL GRANULOMA IS RELATED TO GELOAM. HOWEVER, DURING SURGERY SEVERAL SURGICAL MATERIALS WERE POSSIBLY USED LIKE GAUZE, COTTON BALLS ETC. WHICH COULD ALSO TRIGGER A FOREIGN BODY REACTION. CASE WILL BE REASSESSED AS AND WHEN ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1034894 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |