BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8911125 · Received August 20, 2019

    Report

    Report Number
    2210968-2019-85818
    Event Type
    Injury
    Date Received
    August 20, 2019
    Report Date
    July 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: INT UROGYNECOL J. 2008; 19: 261¿266. DOI: 10.1007/S00192-007-0416-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PARTIAL COLPOCLEISIS FOR THE TREATMENT OF SACROCOLPOPEXY MESH EROSIONS. THE PURPOSE OF THIS STUDY IS TO DESCRIBE THE OUTCOMES OF PARTIAL COLPOCLEISIS FOR MESH EROSIONS AFTER SAROCOLPOPEXY. THE AUTHORS RETROSPECTIVELY REVIEWED 499 SACRAL COLPOPEXIES AND TREATED 21 PATIENTS (AGE: 50.9 ± 11.1 YEARS; ALL FEMALE PATIENTS; BMI: 27.9 ± 5.3) FOR MESH EROSION, INCLUDING REFERRALS. GRAFT MATERIAL USED IN THE INITIAL SACROCOLPOPEXY SURGERY INCLUDED MERSILENE BRAIDED POLYESTER (ETHICON) IN 13 PATIENTS AND PROLENE WOVEN POLYPROPYLENE (ETHICON) IN 7 PATIENTS. IN BOTH GROUPS, REPORTED COMPLICATIONS INCLUDED MESH EROSION (N-20) WHICH WERE TREATED INITIALLY BY EITHER INTRAVAGINAL ESTROGEN CREAM AND/OR TRIMMING OF THE EXPOSED MESH. ALL CASES THAT DID NOT RESPOND TO OFFICE TREATMENT UNDERWENT VAGINAL EXCISION OF THE EXPOSED MESH AND PARTIAL COLPOCLEISIS. THIS STUDY DESCRIBES A SUCCESSFUL TECHNIQUE FOR THE INITIAL MANAGEMENT OF VAGINAL MESH EROSION AFTER SACROCOLPOPEXY. ALTHOUGH THE REASONS FOR SURGICAL FAILURE AFTER MESH EXCISION MAY BE MULTIFACTORIAL, THE AUTHORS IDENTIFIED SMOKING AND CONCURRENT ACTINOMYCES INFECTION AS RISK FACTORS FOR RECURRENT EROSION AND MORBIDITY. THE RESULTS PRESENTED IN THIS STUDY PROVIDE IMPORTANT IMPLICATIONS TO CONSIDER WHEN COUNSELING PATIENTS ABOUT THE SUCCESS OF SURGICAL MANAGEMENT AND POSSIBLE COMPLICATIONS OF PERSISTENT MESH EROSIONS AFTER ABDOMINAL SACROCOLPOPEXY. BASED ON EXPERIENCE, THE AUTHORS RECOMMENDED THE INITIAL SURGICAL OPTION FOR MESH RESECTION TO BE PERFORMED VAGINALLY, AS DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703847 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention