BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8966884 · Received September 5, 2019

    Report

    Report Number
    2210968-2019-86608
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: MENOPAUSE REVIEW 2006; 4: 239-243. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SYSTEMIC ALLERGIC REACTION TO POLYPROPYLENE MESH USED IN SURGICAL TREATMENT OF CYSTOCELE. A CASE REPORT. THIS REPORT PRESENTS THE CASE OF A (B)(6) YEAR OLD FEMALE PATIENT WHO DEVELOPED SIGNS OF SEVERE SYSTEMIC HYPERSENSITIVITY AFTER PROLENE POLYPROPYLENE MESH (ETHICON) WAS USED IN THE SURGICAL TREATMENT OF CYSTOCELE REPAIRED USING THE DOUBLE TOT APPROACH. THE PATIENT WAS ADMITTED BY THE SURGICAL AND ENDOSCOPIC GYNECOLOGY CLINIC AT THE MATKA POLKA HEALTH INSTITUTE IN LÓDZ ON 24 APRIL 2005 DUE TO AN ANTERIOR VAGINAL WALL COLLAPSE WITH A CENTRAL AND LATERAL WALL DEFECT AND CLINICAL SIGNS OF STRESS INCONTINENCE. THE PATIENT¿S MEDICAL HISTORY REVEALED THAT A PREGNANCY TWO YEARS BEFORE HAD ENDED IN A FORCEPS DELIVERY AND SHE ASSOCIATED THE DEVELOPMENT OF THE ABOVE-MENTIONED SYMPTOMS WITH THIS EVENT. ANTERIOR VAGINAL WALL REPAIR WITH PROLENE POLYPROPYLENE MESH (ETHICON) USING THE DOUBLE TOT APPROACH AND POSTERIOR WALL REPAIR WERE RECOMMENDED. THE PATIENT¿S RESULTS OF A HEMATOLOGY AND IMMUNOLOGY (ESPECIALLY A RHEUMATOID FACTOR RF (+) ASSAY AND THE RESULTS OF A RESPIRATORY BURST AND AN IMK ASSAY DEMONSTRATING AN ABNORMAL CD4+/CD8+ RATIO THUS RESULTING IN AN IMBALANCE BETWEEN TH AND TS LYMPHOCYTE POPULATIONS WHILST CD4+ AND CD8+ VALUES REMAINED WITHIN THE NORMAL RANGE) CONSULTATION INDICATED A SYSTEMIC MANIFESTATION OF IMMUNE DISORDERS SECONDARY TO AN ALLERGIC REACTION TO A FOREIGN OBJECT IN WHICH THE PATIENT HAD SYMPTOMATIC TREATMENT INCLUDING ANTIHISTAMINES AND STEROIDS. AN IMPROVEMENT IN THE PATIENT¿S GENERAL CONDITION WAS OBSERVED OVER SUBSEQUENT DAYS. SHE WAS DISCHARGED HOME IN GOOD GENERAL CONDITION. TEN WEEKS AFTER THE PROCEDURE A FOLLOW-UP EXAMINATION REVEALED THAT A MESH FRAGMENT HAD BEEN AFFECTED BY EROSION WITH NO SIGNS OF INFECTION IN WHICH A PROTRUDING FRAGMENT ONE CENTIMETER IN LENGTH WAS RESECTED. THE REMAINING MESH WAS INTEGRATING NORMALLY. THE PATIENT CONTINUES TO MAINTAIN NORMAL URINARY CONTINENCE AND HAS NOT REPORTED ANY SYMPTOMS THAT COULD BE ASSOCIATED WITH THE PRESENCE OF THE DEPLOYED MESH. THE LITERATURE REVIEW BRINGS TO THE FORE THE FACT THAT A HYPERSENSITIVITY REACTION TO POLYPROPYLENE IS INCREDIBLY RARE ¿ EVEN IN PATIENTS THAT HAVE PREVIOUSLY BEEN EXPOSED TO THIS MATERIAL. THE VALUE OF USING THIS SUBSTANCE IN CLINICAL PRACTICE IS THEREFORE UNCOMPROMISED. STANDARD TESTING FOR POLYPROPYLENE ALLERGIES ALSO SEEMS ECONOMICALLY UNJUSTIFIED IN THIS SITUATION. BOTH APPROPRIATE TREATMENT AND DETAILED DIAGNOSTICS MUST BE IMPLEMENTED IN AN APPROPRIATELY RAPID AND PARALLEL MANNER IN THE EVENT OF SIGNS OF AN ALLERGIC REACTION DEVELOPING AFTER THIS MATERIAL IS USED (AS WELL AS OTHER MATERIALS USED DURING SURGICAL PROCEDURES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759399 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention