GELFOAM
Report
- Report Number
- 1810189-2019-00020
- Event Type
- Malfunction
- Date Received
- May 6, 2019
- Report Date
- July 10, 2017
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
EVENT VERBATIM [PREFERRED TERM] UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS [FALSE POSITIVE INVESTIGATION RESULT] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE J ULTRASOUND MED, 2010, 29; 117-120 ENTITLED, 'APPEARANCE OF ABSORBABLE GELATIN COMPRESSED SPONGE ON EARLY POST THYROIDECTOMY NECK SONOGRAPHY A MIMIC OF LOCALLY RECURRENT OR RESIDUAL THYROID CARCINOMA. A CONTACTABLE PHYSICIAN FOR SIX PATIENTS. THIS IS THE 3 OF 6 REPORTS FOR A FEMALE PATIENT OF UNKNOWN AGE. OBJECTIVE: ABSORBABLE GELATIN COMPRESSED SPONGE (GELFOAM) A BIODEGRADABLE AGENT PREPARED FROM PURIFIED PORCINE SKIN GELATIN, IS FREQUENTLY USED FOR INTRAOPERATIVE HEMOSTASIS. ITS APPEARANCE ON SONOGRAPHY MAY MIMIC TUMOR OR RESIDUAL THYROID WHEN PLACED IN THE RESECTION BED AFTER THYROIDECTOMY. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE APPEARANCE OF GELFOAM ON EARLY POST THYROIDECTOMY SONOGRAPHY SO THAT AN ERRONEOUS DIAGNOSIS OF LOCALLY RECURRENT OR RESIDUAL TUMOR CAN BE AVOIDED. METHODS: WE REVIEWED THE EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS AFTER THYROIDECTOMY IN WHICH GELFOAM WAS USED FOR HEMOSTASIS. SCREENING CERVICAL SONOGRAPHY WAS PERFORMED TO IDENTIFY POSSIBLE LATERAL COMPARTMENT ADENOPATHY BEFORE COMPLETION OF THYROIDECTOMY OR ABLATION. SONOGRAPHIC EXAMINATIONS WERE PERFORMED UP TO 50 DAYS AFTER RESECTION. SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM IN EACH PATIENT. RESULTS: IN ALL CASES, UNIFORM ELONGATED ECHOGENICITY WAS SHOWN WITHIN THE LOBECTOMY BED. IN 1 PATIENT, VIA A SONOGRAPHY GUIDED FINE NEEDLE ASPIRATION OF LOBECTOMY BED ECHOGENICITY YIELDED SCANT RED BLOOD CELLS, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. FOLLOW UP SONOGRAPHY PERFORMED IN 1 PATIENT 14 MONTHS AFTER THYROIDECTOMY CONFIRMED COMPLETE GELFOAM ABSORPTION. CONCLUSIONS: GELFOAM MAY MIMIC RESIDUAL OR RECURRENT THYROID CARCINOMA ON EARLY SURVEILLANCE SONOGRAPHY PERFORMED AFTER THYROIDECTOMY. RECOGNITION OF ITS CHARACTERISTIC APPEARANCE SHOULD PROMPT A SEARCH FOR AN APPROPRIATE SURGICAL HISTORY AND, WHEN PLACED IN THE APPROPRIATE CLINICAL CONTEXT, SHOULD PREVENT AN ERRANT DIAGNOSIS OF TUMOR. THE CENTRAL ROLE OF SONOGRAPHY FOR THE POSTOPERATIVE SURVEILLANCE OF DIFFERENTIATED THYROID CARCINOMA HAS BEEN EMPHASIZED IN THE RECENT ENDOCRINE, ENDOCRINE SURGERY, AND RADIOLOGY LITERATURE. THE COMBINATION OF SONOGRAPHY AND SERUM THYROGLOBULIN HAS LARGELY REPLACED IODINE SCINTIGRAPHY AS THE STANDARD OF CARE FOR THE FOLLOW-UP OF PATIENTS WITH THYROID CANCER. INDEED, THE ABILITY OF SONOGRAPHY TO DEPICT OCCULT SMALL VOLUME RESIDUAL OR RECURRENT DISEASE IS UNPARALLELED. THE SONOGRAPHIC APPEARANCE OF LOCALLY RECURRENT THYROID CANCER AND CERVICAL LYMPHADENOPATHY HAS BEEN WELL DESCRIBED. NONETHELESS, EVEN IN EXPERIENCED HANDS, FALSE POSITIVE NECK SONOGRAPHIC FINDINGS INEVITABLY OCCUR. ALTHOUGH SEVERAL FEATURES OF METASTATIC THYROID CARCINOMA (MICRO CALCIFICATIONS AND CYSTIC CHANGES) ARE HIGHLY SPECIFIC, THE IDENTIFICATION OF BORDERLINE ENLARGED LYMPH NODES OR A CENTRAL COMPARTMENT SCAR OFTEN LEADS TO SONOGRAPHICALLY GUIDED FINE NEEDLE ASPIRATION (FNA). SEVERAL STUDIES HAVE ALSO REPORTED HOW A VARIETY OF TOPICAL HEMOSTATIC AGENTS MAY MIMIC ABSCESSES OR TUMOR RECURRENCE. THESE AGENTS ARE USED AT NUMEROUS SITES, INCLUDING THE THYROIDECTOMY BED. ONE SUCH AGENT IS ABSORBABLE GELATIN SPONGE (GELFOAM). WHEN NOT USED IN EXCESSIVE AMOUNTS, GELFOAM IS TYPICALLY COMPLETELY ABSORBED OVER SEVERAL MONTHS, WITH LITTLE TISSUE REACTION. IN OUR OWN CLINICAL PRACTICE, A RECENT ERRANT DIAGNOSIS OF RESIDUAL CENTRAL COMPARTMENT TUMOR IN A PATIENT SCANNED SEVERAL DAYS AFTER THYROID RESECTION MADE US AWARE OF HOW EASILY ABSORBABLE GELATIN SPONGE MAY MIMIC RESIDUAL DISEASE. AWARENESS OF THIS POTENTIAL MIMIC OF RESIDUAL CENTRAL COMPARTMENT TUMOR MAY PREVENT UNNECESSARY SONOGRAPHICALLY GUIDED FNA SAMPLING. MATERIALS AND METHODS: EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS (5 FEMALE AND 1 MALE) WITH IMAGING FEATURES SUGGESTIVE OF LOBECTOMY BED GELFOAM DEPOSITION WERE SELECTED FROM SECTION TEACHING FILES AND ENDOCRINE SURGICAL LOGS. THE EXAMINATION PROTOCOL WAS SIMILAR FOR ALL PATIENTS: REPRESENTATIVE AXIAL SAGITTAL IMAGES OF NODE STATIONS, THE SURGICAL BED, AND REMAINING THYROID (IF A PARTIAL THYROIDECTOMY WAS PERFORMED) WERE ACQUIRED. TWO FELLOWSHIP TRAINED RADIOLOGISTS RETROSPECTIVELY REVIEWED STATIC AND CINE LOOP IMAGES. THE ECHOGENICITY, LOCATION, AND SIZE OF CENTRAL COMPARTMENT RECURRENCE WERE TABULATED. SURGICAL REPORTS AND FOLLOW UP CLINICAL NOTES WERE THEN REVIEWED. RESULTS: THYROIDECTOMIES WERE PERFORMED IN 4 PATIENTS; SURGICAL INDICATIONS IN THIS SUBSET INCLUDED TRACHEAL COMPRESSION BY AN ENLARGED MULTINODULAR GLAND, GRAVE'S DISEASE WITH REPEATEDLY INCONCLUSIVE FNA SAMPLING OF BILATERAL NODULES, INCONCLUSIVE FNA BUT IMAGING FINDINGS CLASSIC FOR MICRO PAPILLARY CARCINOMA/ADJACENT CENTRAL COMPARTMENT ADENOPATHY, AND MULTIPLE NODULES WITH A PRIOR FNA SPECIMEN SHOWING ATYPIA. ALL OF THESE PATIENTS WERE ULTIMATELY SHOWN TO HAVE MULTIFOCAL PAPILLARY CARCINOMA. ONE PATIENT UNDERWENT RIGHT THYROID LOBECTOMY AND ISTHMUSECTOMY FOR PAPILLARY THYROID CARCINOMA THAT UNEXPECTEDLY INVADED THE RECURRENT LARYNGEAL NERVE AND TRACHEA. THE CONTRALATERAL LOBE WAS NOT RESECTED BECAUSE OF A CONCERN FOR BILATERAL RECURRENT NERVE INJURY. THE FINAL PATIENT UNDERWENT DIAGNOSTIC LOBECTOMY AND ISTHMUSECTOMY FOR A 4CM FOLLICULAR LESION THAT WAS REVEALED TO BE FOLLICULAR VARIANT PAPILLARY THYROID CARCINOMA. ALL SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM FOR HEMOSTASIS WITHIN THE LOBECTOMY BEDS. SONOGRAPHIC EXAMINATIONS WERE PERFORMED ON 21, 25, 29, 33, 49, AND 50 DAYS AFTER SURGERY. STUDIES WERE REQUESTED BY REFERRING ENDOCRINOLOGISTS AND ENDOCRINE SURGEONS TO ASSESS RESIDUAL LATERAL COMPARTMENT LYMPHADENOPATHY BEFORE RADIOIODINE ABLATION OR COMPLETION THYROIDECTOMY. ALL PATIENTS HAD SIMILAR CHARACTERISTIC SONOGRAPHIC FINDINGS. UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS WERE IDENTIFIED WITHIN THE LOBECTOMY BED NO CALCIFICATIONS WERE IDENTIFIED, AND COLOR DOPPLER FLOW WAS NOT SHOWN WITHIN THE CENTRAL COMPARTMENT ECHOGENICITY. RESIDUAL GELFOAM MEASURED 2.4 TO 3.9 CM SAGITTAL AND 0.9 TO 1.6 CM TRANSVERSE. SONOGRAPHICALLY GUIDED FNA BIOPSY OF A LESION IN 1 PATIENT WITH SUSPECTED RESIDUAL CENTRAL COMPARTMENT DISEASE 50 DAYS AFTER LOBECTOMY YIELDED SCANT BLOOD, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. RESIDUAL GELFOAM WAS ULTIMATELY DIAGNOSED ON THE BASIS OF THE SURGICAL FINDINGS AND TECHNIQUE. A FOLLOW UP SONOGRAPHIC EXAMINATION PERFORMED 14 MONTHS AFTER INITIAL SURGERY IN ANOTHER PATIENT SHOWED COMPLETE ABSORPTION OF GELFOAM. DISCUSSION: RECENT REVIEWS AND CONSENSUS STATEMENTS HAVE HIGHLIGHTED THE CENTRAL ROLE OF SONOGRAPHY, COUPLED WITH SERUM THYROGLOBULIN MEASUREMENTS, IN THE PREOPERATIVE STAGING AND POSTOPERATIVE SURVEILLANCE OF PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA. THE DIAGNOSTIC ACCURACY OF SONOGRAPHY, ITS LOW COST, AND ITS EASE OF USE HAVE PROMPTED RADIOLOGISTS, ENDOCRINOLOGISTS, AND ENDOCRINE/HEAD AND NECK SURGEONS TO RAPIDLY ADOPT SONOGRAPHY IN THEIR CLINICAL PRACTICES. AS ALWAYS, THE ACCURACY OF SONOGRAPHY IMPROVES WITH GREATER OPERATOR EXPERIENCE, BUT FALSE-POSITIVE FINDINGS STILL OCCUR. BECAUSE SONOGRAPHY IS A STRICTLY ANATOMIC TEST, IT IS OFTEN IMPOSSIBLE TO DIFFERENTIATE METASTATIC ADENOPATHY OR REGIONAL RECURRENCE FROM REACTIVE LYMPH NODES OR A SCAR IN THE THYROID BED. MOREOVER, RESIDUAL OR RECURRENT THYROID TISSUE OR CANCER MAY STILL BE PRESENT IN THE SETTING OF A LOW THYROGLOBULIN LEVEL (PARTICULARLY WHEN ANTITHYROGLOBULIN ANTIBODIES ARE DETECTED). GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC LESION PROMPTED (NON DIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES. WE ARE UNABLE TO ASCERTAIN HOW LONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: THE EVENT "UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/ FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS" WAS DOWNGRADED TO NON-SERIOUS, AND "OFF LABEL USE" DELETED AS EVENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23APR2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP. THIS REPORT INCLUDED THAT: A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. THE COMPLAINT VERBATIM IS AS FOLLOWS: 'GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC "LESION" PROMPTED (NONDIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES (FIGURE 3). WE ARE UNABLE TO ASCERTAIN HOWLONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS14,15; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING.' PCOM NUMBER: # (NOT PROVIDED) HAZARD NUMBER: # (NOT PROVIDED) HAZARDOUS SITUATION (WORST CASE S4): PRODUCT DOES NOT RESORB AFTER IMPLANTATION INTO THE PATIENT NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (02MAY2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP. A COMPLAINT HAS BEEN RECEIVED BY (COMPANY NAME) WITH REASONABLE SUSPICION OF A MALFUNCTION. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. FOLLOW-UP (10JUN2019): NEW INFORMATION WAS RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP. PRODUCT DESC: GELFOAM STERILE SPONGE SIZE 100 X 6 SAP/UNIQUE IDENTIFIER: 0009-0342-01 LOT NUMBER UNKNOWN REASON: COMPLAINANT UNWILLING TO PROVIDE LOT NUMBER UDI: 10300090342019 RETURNED PRODUCT EXAMINATION: DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE TIME PERIOD: 15OCT2014 - 31MAY2019 ROOT CAUSE: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS AND AN EVALUATION OF TRENDS INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. A REVIEW OF STABILITY DATA DEMONSTRATED THE ACCEPTABILITY OF PRODUCT ON THE MARKET. 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, TRENDS, AND INPROCESS 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 DUE TO THE WORST CASE SEVERITY LEVEL OF S4 FOR THE REPORTED DEFECT AS DETERMINED FROM A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. 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. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER IS NOT REQUIRED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT CODED AS FALSE POSITIVE INVESTIGATION RESULT DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK. THERE WAS AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4 NOTED.
UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS [FALSE POSITIVE INVESTIGATION RESULT]. CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE J ULTRASOUND MED, 2010, 29; 117-120 ENTITLED, 'APPEARANCE OF ABSORBABLE GELATIN COMPRESSED SPONGE ON EARLY POST THYROIDECTOMY NECK SONOGRAPHY A MIMIC OF LOCALLY RECURRENT OR RESIDUAL THYROID CARCINOMA. A CONTACTABLE PHYSICIAN FOR SIX PATIENTS. THIS IS THE 3 OF 6 REPORTS FOR A FEMALE PATIENT OF UNKNOWN AGE. OBJECTIVE: ABSORBABLE GELATIN COMPRESSED SPONGE (GELFOAM) A BIODEGRADABLE AGENT PREPARED FROM PURIFIED PORCINE SKIN GELATIN, IS FREQUENTLY USED FOR INTRAOPERATIVE HEMOSTASIS. ITS APPEARANCE ON SONOGRAPHY MAY MIMIC TUMOR OR RESIDUAL THYROID WHEN PLACED IN THE RESECTION BED AFTER THYROIDECTOMY. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE APPEARANCE OF GELFOAM ON EARLY POST THYROIDECTOMY SONOGRAPHY SO THAT AN ERRONEOUS DIAGNOSIS OF LOCALLY RECURRENT OR RESIDUAL TUMOR CAN BE AVOIDED. METHODS: WE REVIEWED THE EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS AFTER THYROIDECTOMY IN WHICH GELFOAM WAS USED FOR HEMOSTASIS. SCREENING CERVICAL SONOGRAPHY WAS PERFORMED TO IDENTIFY POSSIBLE LATERAL COMPARTMENT ADENOPATHY BEFORE COMPLETION OF THYROIDECTOMY OR ABLATION. SONOGRAPHIC EXAMINATIONS WERE PERFORMED UP TO 50 DAYS AFTER RESECTION. SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM IN EACH PATIENT. RESULTS: IN ALL CASES, UNIFORM ELONGATED ECHOGENICITY WAS SHOWN WITHIN THE LOBECTOMY BED. IN 1 PATIENT, VIA A SONOGRAPHY GUIDED FINE NEEDLE ASPIRATION OF LOBECTOMY BED ECHOGENICITY YIELDED SCANT RED BLOOD CELLS, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. FOLLOW UP SONOGRAPHY PERFORMED IN 1 PATIENT 14 MONTHS AFTER THYROIDECTOMY CONFIRMED COMPLETE GELFOAM ABSORPTION. CONCLUSIONS: GELFOAM MAY MIMIC RESIDUAL OR RECURRENT THYROID CARCINOMA ON EARLY SURVEILLANCE SONOGRAPHY PERFORMED AFTER THYROIDECTOMY. RECOGNITION OF ITS CHARACTERISTIC APPEARANCE SHOULD PROMPT A SEARCH FOR AN APPROPRIATE SURGICAL HISTORY AND, WHEN PLACED IN THE APPROPRIATE CLINICAL CONTEXT, SHOULD PREVENT AN ERRANT DIAGNOSIS OF TUMOR. THE CENTRAL ROLE OF SONOGRAPHY FOR THE POSTOPERATIVE SURVEILLANCE OF DIFFERENTIATED THYROID CARCINOMA HAS BEEN EMPHASIZED IN THE RECENT ENDOCRINE, ENDOCRINE SURGERY, AND RADIOLOGY LITERATURE. THE COMBINATION OF SONOGRAPHY AND SERUM THYROGLOBULIN HAS LARGELY REPLACED IODINE SCINTIGRAPHY AS THE STANDARD OF CARE FOR THE FOLLOW-UP OF PATIENTS WITH THYROID CANCER. INDEED, THE ABILITY OF SONOGRAPHY TO DEPICT OCCULT SMALL VOLUME RESIDUAL OR RECURRENT DISEASE IS UNPARALLELED. THE SONOGRAPHIC APPEARANCE OF LOCALLY RECURRENT THYROID CANCER AND CERVICAL LYMPHADENOPATHY HAS BEEN WELL DESCRIBED. NONETHELESS, EVEN IN EXPERIENCED HANDS, FALSE POSITIVE NECK SONOGRAPHIC FINDINGS INEVITABLY OCCUR. ALTHOUGH SEVERAL FEATURES OF METASTATIC THYROID CARCINOMA (MICRO CALCIFICATIONS AND CYSTIC CHANGES) ARE HIGHLY SPECIFIC, THE IDENTIFICATION OF BORDERLINE ENLARGED LYMPH NODES OR A CENTRAL COMPARTMENT SCAR OFTEN LEADS TO SONOGRAPHICALLY GUIDED FINE NEEDLE ASPIRATION (FNA). SEVERAL STUDIES HAVE ALSO REPORTED HOW A VARIETY OF TOPICAL HEMOSTATIC AGENTS MAY MIMIC ABSCESSES OR TUMOR RECURRENCE. THESE AGENTS ARE USED AT NUMEROUS SITES, INCLUDING THE THYROIDECTOMY BED. ONE SUCH AGENT IS ABSORBABLE GELATIN SPONGE (GELFOAM). WHEN NOT USED IN EXCESSIVE AMOUNTS, GELFOAM IS TYPICALLY COMPLETELY ABSORBED OVER SEVERAL MONTHS, WITH LITTLE TISSUE REACTION. IN OUR OWN CLINICAL PRACTICE, A RECENT ERRANT DIAGNOSIS OF RESIDUAL CENTRAL COMPARTMENT TUMOR IN A PATIENT SCANNED SEVERAL DAYS AFTER THYROID RESECTION MADE US AWARE OF HOW EASILY ABSORBABLE GELATIN SPONGE MAY MIMIC RESIDUAL DISEASE. AWARENESS OF THIS POTENTIAL MIMIC OF RESIDUAL CENTRAL COMPARTMENT TUMOR MAY PREVENT UNNECESSARY SONOGRAPHICALLY GUIDED FNA SAMPLING. MATERIALS AND METHODS: EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS (5 FEMALE AND 1 MALE) WITH IMAGING FEATURES SUGGESTIVE OF LOBECTOMY BED GELFOAM DEPOSITION WERE SELECTED FROM SECTION TEACHING FILES AND ENDOCRINE SURGICAL LOGS. THE EXAMINATION PROTOCOL WAS SIMILAR FOR ALL PATIENTS: REPRESENTATIVE AXIAL SAGITTAL IMAGES OF NODE STATIONS, THE SURGICAL BED, AND REMAINING THYROID (IF A PARTIAL THYROIDECTOMY WAS PERFORMED) WERE ACQUIRED. TWO FELLOWSHIP TRAINED RADIOLOGISTS RETROSPECTIVELY REVIEWED STATIC AND CINE LOOP IMAGES. THE ECHOGENICITY, LOCATION, AND SIZE OF CENTRAL COMPARTMENT RECURRENCE WERE TABULATED. SURGICAL REPORTS AND FOLLOW UP CLINICAL NOTES WERE THEN REVIEWED. RESULTS: THYROIDECTOMIES WERE PERFORMED IN 4 PATIENTS; SURGICAL INDICATIONS IN THIS SUBSET INCLUDED TRACHEAL COMPRESSION BY AN ENLARGED MULTINODULAR GLAND, GRAVE'S DISEASE WITH REPEATEDLY INCONCLUSIVE FNA SAMPLING OF BILATERAL NODULES, INCONCLUSIVE FNA BUT IMAGING FINDINGS CLASSIC FOR MICRO PAPILLARY CARCINOMA/ADJACENT CENTRAL COMPARTMENT ADENOPATHY, AND MULTIPLE NODULES WITH A PRIOR FNA SPECIMEN SHOWING ATYPIA. ALL OF THESE PATIENTS WERE ULTIMATELY SHOWN TO HAVE MULTIFOCAL PAPILLARY CARCINOMA. ONE PATIENT UNDERWENT RIGHT THYROID LOBECTOMY AND ISTHMUSECTOMY FOR PAPILLARY THYROID CARCINOMA THAT UNEXPECTEDLY INVADED THE RECURRENT LARYNGEAL NERVE AND TRACHEA. THE CONTRALATERAL LOBE WAS NOT RESECTED BECAUSE OF A CONCERN FOR BILATERAL RECURRENT NERVE INJURY. THE FINAL PATIENT UNDERWENT DIAGNOSTIC LOBECTOMY AND ISTHMUSECTOMY FOR A 4CM FOLLICULAR LESION THAT WAS REVEALED TO BE FOLLICULAR VARIANT PAPILLARY THYROID CARCINOMA. ALL SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM FOR HEMOSTASIS WITHIN THE LOBECTOMY BEDS. SONOGRAPHIC EXAMINATIONS WERE PERFORMED ON 21, 25, 29, 33, 49, AND 50 DAYS AFTER SURGERY. STUDIES WERE REQUESTED BY REFERRING ENDOCRINOLOGISTS AND ENDOCRINE SURGEONS TO ASSESS RESIDUAL LATERAL COMPARTMENT LYMPHADENOPATHY BEFORE RADIOIODINE ABLATION OR COMPLETION THYROIDECTOMY. ALL PATIENTS HAD SIMILAR CHARACTERISTIC SONOGRAPHIC FINDINGS. UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS WERE IDENTIFIED WITHIN THE LOBECTOMY BED NO CALCIFICATIONS WERE IDENTIFIED, AND COLOR DOPPLER FLOW WAS NOT SHOWN WITHIN THE CENTRAL COMPARTMENT ECHOGENICITY. RESIDUAL GELFOAM MEASURED 2.4 TO 3.9 CM SAGITTAL AND 0.9 TO 1.6 CM TRANSVERSE. SONOGRAPHICALLY GUIDED FNA BIOPSY OF A LESION IN 1 PATIENT WITH SUSPECTED RESIDUAL CENTRAL COMPARTMENT DISEASE 50 DAYS AFTER LOBECTOMY YIELDED SCANT BLOOD, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. RESIDUAL GELFOAM WAS ULTIMATELY DIAGNOSED ON THE BASIS OF THE SURGICAL FINDINGS AND TECHNIQUE. A FOLLOW UP SONOGRAPHIC EXAMINATION PERFORMED 14 MONTHS AFTER INITIAL SURGERY IN ANOTHER PATIENT SHOWED COMPLETE ABSORPTION OF GELFOAM. DISCUSSION: RECENT REVIEWS AND CONSENSUS STATEMENTS HAVE HIGHLIGHTED THE CENTRAL ROLE OF SONOGRAPHY, COUPLED WITH SERUM THYROGLOBULIN MEASUREMENTS, IN THE PREOPERATIVE STAGING AND POSTOPERATIVE SURVEILLANCE OF PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA. THE DIAGNOSTIC ACCURACY OF SONOGRAPHY, ITS LOW COST, AND ITS EASE OF USE HAVE PROMPTED RADIOLOGISTS, ENDOCRINOLOGISTS, AND ENDOCRINE/HEAD AND NECK SURGEONS TO RAPIDLY ADOPT SONOGRAPHY IN THEIR CLINICAL PRACTICES. AS ALWAYS, THE ACCURACY OF SONOGRAPHY IMPROVES WITH GREATER OPERATOR EXPERIENCE, BUT FALSE-POSITIVE FINDINGS STILL OCCUR. BECAUSE SONOGRAPHY IS A STRICTLY ANATOMIC TEST, IT IS OFTEN IMPOSSIBLE TO DIFFERENTIATE METASTATIC ADENOPATHY OR REGIONAL RECURRENCE FROM REACTIVE LYMPH NODES OR A SCAR IN THE THYROID BED. MOREOVER, RESIDUAL OR RECURRENT THYROID TISSUE OR CANCER MAY STILL BE PRESENT IN THE SETTING OF A LOW THYROGLOBULIN LEVEL (PARTICULARLY WHEN ANTITHYROGLOBULIN ANTIBODIES ARE DETECTED). GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC LESION PROMPTED (NON DIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES. WE ARE UNABLE TO ASCERTAIN HOW LONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: THE EVENT "UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/ FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS" WAS DOWNGRADED TO NON-SERIOUS, AND "OFF LABEL USE" DELETED AS EVENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23APR2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP. THIS REPORT INCLUDED THAT: A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. THE COMPLAINT VERBATIM IS AS FOLLOWS: 'GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC "LESION" PROMPTED (NONDIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES (FIGURE 3). WE ARE UNABLE TO ASCERTAIN HOWLONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS14,15; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING.' PCOM NUMBER: # (NOT PROVIDED). HAZARD NUMBER: # (NOT PROVIDED). HAZARDOUS SITUATION (WORST CASE S4): PRODUCT DOES NOT RESORB AFTER IMPLANTATION INTO THE PATIENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. CASE COMMENT: THE REPORTED EVENT CODED AS FALSE POSITIVE INVESTIGATION RESULT DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK. THERE WAS AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4.
EVENT VERBATIM [PREFERRED TERM] UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS [FALSE POSITIVE INVESTIGATION RESULT] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE J ULTRASOUND MED, 2010, 29; 117-120 ENTITLED, 'APPEARANCE OF ABSORBABLE GELATIN COMPRESSED SPONGE ON EARLY POST THYROIDECTOMY NECK SONOGRAPHY A MIMIC OF LOCALLY RECURRENT OR RESIDUAL THYROID CARCINOMA. A CONTACTABLE PHYSICIAN FOR SIX PATIENTS. THIS IS THE 3 OF 6 REPORTS FOR A FEMALE PATIENT OF UNKNOWN AGE. OBJECTIVE: ABSORBABLE GELATIN COMPRESSED SPONGE (GELFOAM) A BIODEGRADABLE AGENT PREPARED FROM PURIFIED PORCINE SKIN GELATIN, IS FREQUENTLY USED FOR INTRAOPERATIVE HEMOSTASIS. ITS APPEARANCE ON SONOGRAPHY MAY MIMIC TUMOR OR RESIDUAL THYROID WHEN PLACED IN THE RESECTION BED AFTER THYROIDECTOMY. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE APPEARANCE OF GELFOAM ON EARLY POST THYROIDECTOMY SONOGRAPHY SO THAT AN ERRONEOUS DIAGNOSIS OF LOCALLY RECURRENT OR RESIDUAL TUMOR CAN BE AVOIDED. METHODS: WE REVIEWED THE EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS AFTER THYROIDECTOMY IN WHICH GELFOAM WAS USED FOR HEMOSTASIS. SCREENING CERVICAL SONOGRAPHY WAS PERFORMED TO IDENTIFY POSSIBLE LATERAL COMPARTMENT ADENOPATHY BEFORE COMPLETION OF THYROIDECTOMY OR ABLATION. SONOGRAPHIC EXAMINATIONS WERE PERFORMED UP TO 50 DAYS AFTER RESECTION. SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM IN EACH PATIENT. RESULTS: IN ALL CASES, UNIFORM ELONGATED ECHOGENICITY WAS SHOWN WITHIN THE LOBECTOMY BED. IN 1 PATIENT, VIA A SONOGRAPHY GUIDED FINE NEEDLE ASPIRATION OF LOBECTOMY BED ECHOGENICITY YIELDED SCANT RED BLOOD CELLS, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. FOLLOW UP SONOGRAPHY PERFORMED IN 1 PATIENT 14 MONTHS AFTER THYROIDECTOMY CONFIRMED COMPLETE GELFOAM ABSORPTION. CONCLUSIONS: GELFOAM MAY MIMIC RESIDUAL OR RECURRENT THYROID CARCINOMA ON EARLY SURVEILLANCE SONOGRAPHY PERFORMED AFTER THYROIDECTOMY. RECOGNITION OF ITS CHARACTERISTIC APPEARANCE SHOULD PROMPT A SEARCH FOR AN APPROPRIATE SURGICAL HISTORY AND, WHEN PLACED IN THE APPROPRIATE CLINICAL CONTEXT, SHOULD PREVENT AN ERRANT DIAGNOSIS OF TUMOR. THE CENTRAL ROLE OF SONOGRAPHY FOR THE POSTOPERATIVE SURVEILLANCE OF DIFFERENTIATED THYROID CARCINOMA HAS BEEN EMPHASIZED IN THE RECENT ENDOCRINE, ENDOCRINE SURGERY, AND RADIOLOGY LITERATURE. THE COMBINATION OF SONOGRAPHY AND SERUM THYROGLOBULIN HAS LARGELY REPLACED IODINE SCINTIGRAPHY AS THE STANDARD OF CARE FOR THE FOLLOW-UP OF PATIENTS WITH THYROID CANCER. INDEED, THE ABILITY OF SONOGRAPHY TO DEPICT OCCULT SMALL VOLUME RESIDUAL OR RECURRENT DISEASE IS UNPARALLELED. THE SONOGRAPHIC APPEARANCE OF LOCALLY RECURRENT THYROID CANCER AND CERVICAL LYMPHADENOPATHY HAS BEEN WELL DESCRIBED. NONETHELESS, EVEN IN EXPERIENCED HANDS, FALSE POSITIVE NECK SONOGRAPHIC FINDINGS INEVITABLY OCCUR. ALTHOUGH SEVERAL FEATURES OF METASTATIC THYROID CARCINOMA (MICRO CALCIFICATIONS AND CYSTIC CHANGES) ARE HIGHLY SPECIFIC, THE IDENTIFICATION OF BORDERLINE ENLARGED LYMPH NODES OR A CENTRAL COMPARTMENT SCAR OFTEN LEADS TO SONOGRAPHICALLY GUIDED FINE NEEDLE ASPIRATION (FNA). SEVERAL STUDIES HAVE ALSO REPORTED HOW A VARIETY OF TOPICAL HEMOSTATIC AGENTS MAY MIMIC ABSCESSES OR TUMOR RECURRENCE. THESE AGENTS ARE USED AT NUMEROUS SITES, INCLUDING THE THYROIDECTOMY BED. ONE SUCH AGENT IS ABSORBABLE GELATIN SPONGE (GELFOAM). WHEN NOT USED IN EXCESSIVE AMOUNTS, GELFOAM IS TYPICALLY COMPLETELY ABSORBED OVER SEVERAL MONTHS, WITH LITTLE TISSUE REACTION. IN OUR OWN CLINICAL PRACTICE, A RECENT ERRANT DIAGNOSIS OF RESIDUAL CENTRAL COMPARTMENT TUMOR IN A PATIENT SCANNED SEVERAL DAYS AFTER THYROID RESECTION MADE US AWARE OF HOW EASILY ABSORBABLE GELATIN SPONGE MAY MIMIC RESIDUAL DISEASE. AWARENESS OF THIS POTENTIAL MIMIC OF RESIDUAL CENTRAL COMPARTMENT TUMOR MAY PREVENT UNNECESSARY SONOGRAPHICALLY GUIDED FNA SAMPLING. MATERIALS AND METHODS: EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS (5 FEMALE AND 1 MALE) WITH IMAGING FEATURES SUGGESTIVE OF LOBECTOMY BED GELFOAM DEPOSITION WERE SELECTED FROM SECTION TEACHING FILES AND ENDOCRINE SURGICAL LOGS. THE EXAMINATION PROTOCOL WAS SIMILAR FOR ALL PATIENTS: REPRESENTATIVE AXIAL SAGITTAL IMAGES OF NODE STATIONS, THE SURGICAL BED, AND REMAINING THYROID (IF A PARTIAL THYROIDECTOMY WAS PERFORMED) WERE ACQUIRED. TWO FELLOWSHIP TRAINED RADIOLOGISTS RETROSPECTIVELY REVIEWED STATIC AND CINE LOOP IMAGES. THE ECHOGENICITY, LOCATION, AND SIZE OF CENTRAL COMPARTMENT RECURRENCE WERE TABULATED. SURGICAL REPORTS AND FOLLOW UP CLINICAL NOTES WERE THEN REVIEWED. RESULTS: THYROIDECTOMIES WERE PERFORMED IN 4 PATIENTS; SURGICAL INDICATIONS IN THIS SUBSET INCLUDED TRACHEAL COMPRESSION BY AN ENLARGED MULTINODULAR GLAND, GRAVE'S DISEASE WITH REPEATEDLY INCONCLUSIVE FNA SAMPLING OF BILATERAL NODULES, INCONCLUSIVE FNA BUT IMAGING FINDINGS CLASSIC FOR MICRO PAPILLARY CARCINOMA/ADJACENT CENTRAL COMPARTMENT ADENOPATHY, AND MULTIPLE NODULES WITH A PRIOR FNA SPECIMEN SHOWING ATYPIA. ALL OF THESE PATIENTS WERE ULTIMATELY SHOWN TO HAVE MULTIFOCAL PAPILLARY CARCINOMA. ONE PATIENT UNDERWENT RIGHT THYROID LOBECTOMY AND ISTHMUSECTOMY FOR PAPILLARY THYROID CARCINOMA THAT UNEXPECTEDLY INVADED THE RECURRENT LARYNGEAL NERVE AND TRACHEA. THE CONTRALATERAL LOBE WAS NOT RESECTED BECAUSE OF A CONCERN FOR BILATERAL RECURRENT NERVE INJURY. THE FINAL PATIENT UNDERWENT DIAGNOSTIC LOBECTOMY AND ISTHMUSECTOMY FOR A 4CM FOLLICULAR LESION THAT WAS REVEALED TO BE FOLLICULAR VARIANT PAPILLARY THYROID CARCINOMA. ALL SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM FOR HEMOSTASIS WITHIN THE LOBECTOMY BEDS. SONOGRAPHIC EXAMINATIONS WERE PERFORMED ON 21, 25, 29, 33, 49, AND 50 DAYS AFTER SURGERY. STUDIES WERE REQUESTED BY REFERRING ENDOCRINOLOGISTS AND ENDOCRINE SURGEONS TO ASSESS RESIDUAL LATERAL COMPARTMENT LYMPHADENOPATHY BEFORE RADIOIODINE ABLATION OR COMPLETION THYROIDECTOMY. ALL PATIENTS HAD SIMILAR CHARACTERISTIC SONOGRAPHIC FINDINGS. UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS WERE IDENTIFIED WITHIN THE LOBECTOMY BED NO CALCIFICATIONS WERE IDENTIFIED, AND COLOR DOPPLER FLOW WAS NOT SHOWN WITHIN THE CENTRAL COMPARTMENT ECHOGENICITY. RESIDUAL GELFOAM MEASURED 2.4 TO 3.9 CM SAGITTAL AND 0.9 TO 1.6 CM TRANSVERSE. SONOGRAPHICALLY GUIDED FNA BIOPSY OF A LESION IN 1 PATIENT WITH SUSPECTED RESIDUAL CENTRAL COMPARTMENT DISEASE 50 DAYS AFTER LOBECTOMY YIELDED SCANT BLOOD, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. RESIDUAL GELFOAM WAS ULTIMATELY DIAGNOSED ON THE BASIS OF THE SURGICAL FINDINGS AND TECHNIQUE. A FOLLOW UP SONOGRAPHIC EXAMINATION PERFORMED 14 MONTHS AFTER INITIAL SURGERY IN ANOTHER PATIENT SHOWED COMPLETE ABSORPTION OF GELFOAM. DISCUSSION: RECENT REVIEWS AND CONSENSUS STATEMENTS HAVE HIGHLIGHTED THE CENTRAL ROLE OF SONOGRAPHY, COUPLED WITH SERUM THYROGLOBULIN MEASUREMENTS, IN THE PREOPERATIVE STAGING AND POSTOPERATIVE SURVEILLANCE OF PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA. THE DIAGNOSTIC ACCURACY OF SONOGRAPHY, ITS LOW COST, AND ITS EASE OF USE HAVE PROMPTED RADIOLOGISTS, ENDOCRINOLOGISTS, AND ENDOCRINE/HEAD AND NECK SURGEONS TO RAPIDLY ADOPT SONOGRAPHY IN THEIR CLINICAL PRACTICES. AS ALWAYS, THE ACCURACY OF SONOGRAPHY IMPROVES WITH GREATER OPERATOR EXPERIENCE, BUT FALSE-POSITIVE FINDINGS STILL OCCUR. BECAUSE SONOGRAPHY IS A STRICTLY ANATOMIC TEST, IT IS OFTEN IMPOSSIBLE TO DIFFERENTIATE METASTATIC ADENOPATHY OR REGIONAL RECURRENCE FROM REACTIVE LYMPH NODES OR A SCAR IN THE THYROID BED. MOREOVER, RESIDUAL OR RECURRENT THYROID TISSUE OR CANCER MAY STILL BE PRESENT IN THE SETTING OF A LOW THYROGLOBULIN LEVEL (PARTICULARLY WHEN ANTITHYROGLOBULIN ANTIBODIES ARE DETECTED). GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC LESION PROMPTED (NON DIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES. WE ARE UNABLE TO ASCERTAIN HOW LONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: THE EVENT "UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/ FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS" WAS DOWNGRADED TO NON-SERIOUS, AND "OFF LABEL USE" DELETED AS EVENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23APR2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP. THIS REPORT INCLUDED THAT: A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. THE COMPLAINT VERBATIM IS AS FOLLOWS: 'GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC "LESION" PROMPTED (NONDIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES (FIGURE 3). WE ARE UNABLE TO ASCERTAIN HOWLONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS14,15; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING.' PCOM NUMBER: # (NOT PROVIDED). HAZARD NUMBER: # (NOT PROVIDED). HAZARDOUS SITUATION (WORST CASE S4): PRODUCT DOES NOT RESORB AFTER IMPLANTATION INTO THE PATIENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (02MAY2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP. A COMPLAINT HAS BEEN RECEIVED BY (COMPANY NAME) WITH REASONABLE SUSPICION OF A MALFUNCTION. IMPACT TO THE DEVICE: DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. CASE COMMENT: THE REPORTED EVENT CODED AS FALSE POSITIVE INVESTIGATION RESULT DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK. THERE WAS AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4 NOTED., COMMENT: THE REPORTED EVENT CODED AS FALSE POSITIVE INVESTIGATION RESULT DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK. THERE WAS AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. DEVICE INTERFERES WITH WOUND HEALING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4 NOTED.
EVENT VERBATIM [PREFERRED TERM] UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS [FALSE POSITIVE INVESTIGATION RESULT]. CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE J ULTRASOUND MED, 2010, 29; 117-120 ENTITLED, 'APPEARANCE OF ABSORBABLE GELATIN COMPRESSED SPONGE ON EARLY POST THYROIDECTOMY NECK SONOGRAPHY A MIMIC OF LOCALLY RECURRENT OR RESIDUAL THYROID CARCINOMA. A CONTACTABLE PHYSICIAN FOR SIX PATIENTS. THIS IS THE 3 OF 6 REPORTS FOR A FEMALE PATIENT OF UNKNOWN AGE. OBJECTIVE: ABSORBABLE GELATIN COMPRESSED SPONGE (GELFOAM) A BIODEGRADABLE AGENT PREPARED FROM PURIFIED PORCINE SKIN GELATIN, IS FREQUENTLY USED FOR INTRAOPERATIVE HEMOSTASIS. ITS APPEARANCE ON SONOGRAPHY MAY MIMIC TUMOR OR RESIDUAL THYROID WHEN PLACED IN THE RESECTION BED AFTER THYROIDECTOMY. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE APPEARANCE OF GELFOAM ON EARLY POST THYROIDECTOMY SONOGRAPHY SO THAT AN ERRONEOUS DIAGNOSIS OF LOCALLY RECURRENT OR RESIDUAL TUMOR CAN BE AVOIDED. METHODS: WE REVIEWED THE EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS AFTER THYROIDECTOMY IN WHICH GELFOAM WAS USED FOR HEMOSTASIS. SCREENING CERVICAL SONOGRAPHY WAS PERFORMED TO IDENTIFY POSSIBLE LATERAL COMPARTMENT ADENOPATHY BEFORE COMPLETION OF THYROIDECTOMY OR ABLATION. SONOGRAPHIC EXAMINATIONS WERE PERFORMED UP TO 50 DAYS AFTER RESECTION. SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM IN EACH PATIENT. RESULTS: IN ALL CASES, UNIFORM ELONGATED ECHOGENICITY WAS SHOWN WITHIN THE LOBECTOMY BED. IN 1 PATIENT, VIA A SONOGRAPHY GUIDED FINE NEEDLE ASPIRATION OF LOBECTOMY BED ECHOGENICITY YIELDED SCANT RED BLOOD CELLS, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. FOLLOW UP SONOGRAPHY PERFORMED IN 1 PATIENT 14 MONTHS AFTER THYROIDECTOMY CONFIRMED COMPLETE GELFOAM ABSORPTION. CONCLUSIONS: GELFOAM MAY MIMIC RESIDUAL OR RECURRENT THYROID CARCINOMA ON EARLY SURVEILLANCE SONOGRAPHY PERFORMED AFTER THYROIDECTOMY. RECOGNITION OF ITS CHARACTERISTIC APPEARANCE SHOULD PROMPT A SEARCH FOR AN APPROPRIATE SURGICAL HISTORY AND, WHEN PLACED IN THE APPROPRIATE CLINICAL CONTEXT, SHOULD PREVENT AN ERRANT DIAGNOSIS OF TUMOR. THE CENTRAL ROLE OF SONOGRAPHY FOR THE POSTOPERATIVE SURVEILLANCE OF DIFFERENTIATED THYROID CARCINOMA HAS BEEN EMPHASIZED IN THE RECENT ENDOCRINE, ENDOCRINE SURGERY, AND RADIOLOGY LITERATURE. THE COMBINATION OF SONOGRAPHY AND SERUM THYROGLOBULIN HAS LARGELY REPLACED IODINE SCINTIGRAPHY AS THE STANDARD OF CARE FOR THE FOLLOW-UP OF PATIENTS WITH THYROID CANCER. INDEED, THE ABILITY OF SONOGRAPHY TO DEPICT OCCULT SMALL VOLUME RESIDUAL OR RECURRENT DISEASE IS UNPARALLELED. THE SONOGRAPHIC APPEARANCE OF LOCALLY RECURRENT THYROID CANCER AND CERVICAL LYMPHADENOPATHY HAS BEEN WELL DESCRIBED. NONETHELESS, EVEN IN EXPERIENCED HANDS, FALSE POSITIVE NECK SONOGRAPHIC FINDINGS INEVITABLY OCCUR. ALTHOUGH SEVERAL FEATURES OF METASTATIC THYROID CARCINOMA (MICRO CALCIFICATIONS AND CYSTIC CHANGES) ARE HIGHLY SPECIFIC, THE IDENTIFICATION OF BORDERLINE ENLARGED LYMPH NODES OR A CENTRAL COMPARTMENT SCAR OFTEN LEADS TO SONOGRAPHICALLY GUIDED FINE NEEDLE ASPIRATION (FNA). SEVERAL STUDIES HAVE ALSO REPORTED HOW A VARIETY OF TOPICAL HEMOSTATIC AGENTS MAY MIMIC ABSCESSES OR TUMOR RECURRENCE. THESE AGENTS ARE USED AT NUMEROUS SITES, INCLUDING THE THYROIDECTOMY BED. ONE SUCH AGENT IS ABSORBABLE GELATIN SPONGE (GELFOAM). WHEN NOT USED IN EXCESSIVE AMOUNTS, GELFOAM IS TYPICALLY COMPLETELY ABSORBED OVER SEVERAL MONTHS, WITH LITTLE TISSUE REACTION. IN OUR OWN CLINICAL PRACTICE, A RECENT ERRANT DIAGNOSIS OF RESIDUAL CENTRAL COMPARTMENT TUMOR IN A PATIENT SCANNED SEVERAL DAYS AFTER THYROID RESECTION MADE US AWARE OF HOW EASILY ABSORBABLE GELATIN SPONGE MAY MIMIC RESIDUAL DISEASE. AWARENESS OF THIS POTENTIAL MIMIC OF RESIDUAL CENTRAL COMPARTMENT TUMOR MAY PREVENT UNNECESSARY SONOGRAPHICALLY GUIDED FNA SAMPLING. MATERIALS AND METHODS: EARLY POSTOPERATIVE SONOGRAPHIC EXAMINATIONS OF 6 PATIENTS (5 FEMALE AND 1 MALE) WITH IMAGING FEATURES SUGGESTIVE OF LOBECTOMY BED GELFOAM DEPOSITION WERE SELECTED FROM SECTION TEACHING FILES AND ENDOCRINE SURGICAL LOGS. THE EXAMINATION PROTOCOL WAS SIMILAR FOR ALL PATIENTS: REPRESENTATIVE AXIAL SAGITTAL IMAGES OF NODE STATIONS, THE SURGICAL BED, AND REMAINING THYROID (IF A PARTIAL THYROIDECTOMY WAS PERFORMED) WERE ACQUIRED. TWO FELLOWSHIP TRAINED RADIOLOGISTS RETROSPECTIVELY REVIEWED STATIC AND CINE LOOP IMAGES. THE ECHOGENICITY, LOCATION, AND SIZE OF CENTRAL COMPARTMENT RECURRENCE WERE TABULATED. SURGICAL REPORTS AND FOLLOW UP CLINICAL NOTES WERE THEN REVIEWED. RESULTS: THYROIDECTOMIES WERE PERFORMED IN 4 PATIENTS; SURGICAL INDICATIONS IN THIS SUBSET INCLUDED TRACHEAL COMPRESSION BY AN ENLARGED MULTINODULAR GLAND, GRAVE'S DISEASE WITH REPEATEDLY INCONCLUSIVE FNA SAMPLING OF BILATERAL NODULES, INCONCLUSIVE FNA BUT IMAGING FINDINGS CLASSIC FOR MICRO PAPILLARY CARCINOMA/ADJACENT CENTRAL COMPARTMENT ADENOPATHY, AND MULTIPLE NODULES WITH A PRIOR FNA SPECIMEN SHOWING ATYPIA. ALL OF THESE PATIENTS WERE ULTIMATELY SHOWN TO HAVE MULTIFOCAL PAPILLARY CARCINOMA. ONE PATIENT UNDERWENT RIGHT THYROID LOBECTOMY AND ISTHMUSECTOMY FOR PAPILLARY THYROID CARCINOMA THAT UNEXPECTEDLY INVADED THE RECURRENT LARYNGEAL NERVE AND TRACHEA. THE CONTRALATERAL LOBE WAS NOT RESECTED BECAUSE OF A CONCERN FOR BILATERAL RECURRENT NERVE INJURY. THE FINAL PATIENT UNDERWENT DIAGNOSTIC LOBECTOMY AND ISTHMUSECTOMY FOR A 4CM FOLLICULAR LESION THAT WAS REVEALED TO BE FOLLICULAR VARIANT PAPILLARY THYROID CARCINOMA. ALL SURGICAL REPORTS CONFIRMED THE USE OF GELFOAM FOR HEMOSTASIS WITHIN THE LOBECTOMY BEDS. SONOGRAPHIC EXAMINATIONS WERE PERFORMED ON 21, 25, 29, 33, 49, AND 50 DAYS AFTER SURGERY. STUDIES WERE REQUESTED BY REFERRING ENDOCRINOLOGISTS AND ENDOCRINE SURGEONS TO ASSESS RESIDUAL LATERAL COMPARTMENT LYMPHADENOPATHY BEFORE RADIOIODINE ABLATION OR COMPLETION THYROIDECTOMY. ALL PATIENTS HAD SIMILAR CHARACTERISTIC SONOGRAPHIC FINDINGS. UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS WERE IDENTIFIED WITHIN THE LOBECTOMY BED NO CALCIFICATIONS WERE IDENTIFIED, AND COLOR DOPPLER FLOW WAS NOT SHOWN WITHIN THE CENTRAL COMPARTMENT ECHOGENICITY. RESIDUAL GELFOAM MEASURED 2.4 TO 3.9 CM SAGITTAL AND 0.9 TO 1.6 CM TRANSVERSE. SONOGRAPHICALLY GUIDED FNA BIOPSY OF A LESION IN 1 PATIENT WITH SUSPECTED RESIDUAL CENTRAL COMPARTMENT DISEASE 50 DAYS AFTER LOBECTOMY YIELDED SCANT BLOOD, MULTINUCLEATED GIANT CELLS, AND MACROPHAGES. RESIDUAL GELFOAM WAS ULTIMATELY DIAGNOSED ON THE BASIS OF THE SURGICAL FINDINGS AND TECHNIQUE. A FOLLOW UP SONOGRAPHIC EXAMINATION PERFORMED 14 MONTHS AFTER INITIAL SURGERY IN ANOTHER PATIENT SHOWED COMPLETE ABSORPTION OF GELFOAM. DISCUSSION: RECENT REVIEWS AND CONSENSUS STATEMENTS HAVE HIGHLIGHTED THE CENTRAL ROLE OF SONOGRAPHY, COUPLED WITH SERUM THYROGLOBULIN MEASUREMENTS, IN THE PREOPERATIVE STAGING AND POSTOPERATIVE SURVEILLANCE OF PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA. THE DIAGNOSTIC ACCURACY OF SONOGRAPHY, ITS LOW COST, AND ITS EASE OF USE HAVE PROMPTED RADIOLOGISTS, ENDOCRINOLOGISTS, AND ENDOCRINE/HEAD AND NECK SURGEONS TO RAPIDLY ADOPT SONOGRAPHY IN THEIR CLINICAL PRACTICES. AS ALWAYS, THE ACCURACY OF SONOGRAPHY IMPROVES WITH GREATER OPERATOR EXPERIENCE, BUT FALSE-POSITIVE FINDINGS STILL OCCUR. BECAUSE SONOGRAPHY IS A STRICTLY ANATOMIC TEST, IT IS OFTEN IMPOSSIBLE TO DIFFERENTIATE METASTATIC ADENOPATHY OR REGIONAL RECURRENCE FROM REACTIVE LYMPH NODES OR A SCAR IN THE THYROID BED. MOREOVER, RESIDUAL OR RECURRENT THYROID TISSUE OR CANCER MAY STILL BE PRESENT IN THE SETTING OF A LOW THYROGLOBULIN LEVEL (PARTICULARLY WHEN ANTITHYROGLOBULIN ANTIBODIES ARE DETECTED). GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC LESION PROMPTED (NON DIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES. WE ARE UNABLE TO ASCERTAIN HOW LONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: THE EVENT "UNIFORM ELONGATED ECHOGENIC LESIONS WITH THIN HYPOECHOIC HALOS/ FALSE-POSITIVE NECK SONOGRAPHIC FINDINGS" WAS DOWNGRADED TO NON-SERIOUS, AND "OFF LABEL USE" DELETED AS EVENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23APR2019): THIS IS A FOLLOW-UP REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP. THIS REPORT INCLUDED THAT: A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4. THE COMPLAINT VERBATIM IS AS FOLLOWS: 'GELFOAM, A TOPICAL HEMOSTATIC AGENT PREPARED FROM PORCINE SKIN GELATIN, CAN MIMIC RESIDUAL THYROID TISSUE OR TUMOR ON EARLY POSTOPERATIVE SONOGRAPHY. INDEED, THE SONOGRAPHIC APPEARANCE OF GELFOAM AS A UNIFORM ECHOGENIC "LESION" PROMPTED (NONDIAGNOSTIC) SONOGRAPHICALLY GUIDED FNA BIOPSY OF THE FIRST PATIENT INCLUDED IN OUR SERIES. THIS EXPERIENCE ALLOWED US TO CONFIDENTLY DIAGNOSE RESIDUAL GELFOAM (AND NOT CENTRAL COMPARTMENT TUMOR) IN 5 ADDITIONAL PATIENTS INCLUDED IN THIS SERIES (FIGURE 3). WE ARE UNABLE TO ASCERTAIN HOWLONG GELFOAM PERSISTS AFTER THYROID SURGERY. IT HAS BEEN REPORTED THAT ABSORBABLE GELATIN IN SOFT TISSUE SHOULD BE COMPLETELY ABSORBED WITHIN 4 TO 6 WEEKS 14,15; NONETHELESS, IN OUR SERIES, GELFOAM WAS STILL APPARENT ON SONOGRAPHY UP TO 7 WEEKS AFTER SURGERY. GELFOAM WAS NO LONGER APPARENT IN 1 PATIENT SCANNED 14 MONTHS AFTER SURGERY. IN CONCLUSION, RECOGNITION OF THE TYPICAL APPEARANCE OF GELFOAM ON EARLY POSTOPERATIVE SONOGRAPHY SHOULD HELP PREVENT AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING.' PCOM NUMBER: # (NOT PROVIDED). HAZARD NUMBER: # (NOT PROVIDED). HAZARDOUS SITUATION (WORST CASE S4): PRODUCT DOES NOT RESORB AFTER IMPLANTATION INTO THE PATIENT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. CASE COMMENT: THE REPORTED EVENT CODED AS FALSE POSITIVE INVESTIGATION RESULT DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK. THERE WAS AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4., COMMENT: THE REPORTED EVENT CODED AS FALSE POSITIVE INVESTIGATION RESULT DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK. THERE WAS AN ERRONEOUS INTERPRETATION OF RESIDUAL OR RAPIDLY RECURRENT THYROID TUMOR AFTER THYROIDECTOMY. ALTHOUGH SUSPICIOUS THYROID BED LESIONS SHOULD UNDERGO DIAGNOSTIC FNA, RECOGNITION OF THE APPEARANCE OF GELFOAM AND OTHER TOPICAL HEMOSTATIC AGENTS MIMICKING TUMORS SHOULD INCREASE THE ACCURACY OF EARLY POSTOPERATIVE SONOGRAPHY FOR THYROID CANCER SURVEILLANCE AND CERVICAL LYMPH NODE STAGING. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH CONFIRMATION OF A MALFUNCTION. IMPACT TO THE DEVICE: FAILURE TO REABSORB, REABSORPTION TAKES LONGER THAN EXPECTED, AND PRODUCT SWELLING, WITH AN ASSOCIATED WORST CASE SEVERITY OF S4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374296 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |