BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8923742 · Received August 22, 2019

    Report

    Report Number
    2210968-2019-86030
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: HERNIA (2002) 5: 192¿195; DOI 10.1007/S10029-001-0029-X. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ENDOSCOPIC REPAIR OF BILATERAL INGUINAL HERNIAS ¿ SHORT AND LATE OUTCOME. THE AIM OF THIS RETROSPECTIVE STUDY OF MEDICA RECORDS WAS TO EVALUATE THE OUTCOME OF ALL LAPAROSCOPIC SIMULTANEOUS BILATERAL HERNIA REPAIRS AT A SINGLE CENTER, FOCUSING ON COMPLICATIONS, RECURRENCE RATE, AND LATE DISCOMFORT. BETWEEN OCT1993 AND DEC1998, 168 PATIENTS (N=163 MALE AND N=5 FEMALE; MEDIAN AGE OF 64 YEARS (26-86 YEARS) WITH 336 INGUINAL HERNIAS UNDERWENT SIMULTANEOUS LAPAROSCOPIC OPERATION IN WHICH TWO OPERATIVE TECHNIQUES WERE USED: TRANS-ABDOMINAL PREPERITONEAL PATCH (TAPP) AND TOTALLY EXTRAPERITONEAL PATCH (TEP). BOTH REPAIR TECHNIQUES UTILIZED POLYPROPYLENE MESH (PROLENE, ETHICON, SOMERVILLE, N.J.). ADDITIONALLY IN TAPP REPAIR, THE MESH WAS FIXED WITH ENDOSCOPIC STAPLER (EMS MULTIFEED STAPLEGUN, ETHICON) AND THE TWO MESHES OVERLAPPED IN THE MIDLINE. MINOR COMPLICATIONS INCLUDED HEMATOMA (N=7) WHICH WERE TREATED CONSERVATIVELY; SEROMA (N=5) IN WHICH TWO PATIENTS WERE TREATED WITH PUNCTURE AND ASPIRATION; WOUND INFECTION (N=1) AND NEURALGIA (N=1). MAJOR COMPLICATIONS INCLUDED SMALL BOWEL OBSTRUCTION DUE TO ADHESIONS BETWEEN THE MESH AND THE SMALL BOWEL (N=1) IN WHICH THE PATIENT WAS RE-ADMITTED 6 WEEKS POSTOPERATIVELY; AND LATE-ONSET DEEP PROSTHETIC INFECTION (N=1) IN WHICH PATIENT WAS RE-OPERATED AND THE MESH WAS REMOVED. IN TAPP REPAIR, RECURRENCE (N=9) WAS OBSERVED AT A MEDIAN FOLLOW-UP OF 36 MONTHS. EIGHT OF NINE RECURRENCES APPEARED AFTER REPAIRS USING SMALL MESHES AND ONE OF OUR CONCLUSIONS FROM THIS STUDY IS THAT IT IS IMPORTANT TO USE BIG MESHES THAT OVERLAP IN THE MIDLINE. THE SMALL-BOWEL OBSTRUCTION IS THE ONLY COMPLICATION SPECIFICALLY RELATED TO THE TAPP TECHNIQUE. LAPAROSCOPIC SIMULTANEOUS OPERATION OF BILATERAL INGUINAL HERNIAS IS SAFE AND THAT COMPLICATIONS, RECURRENCE RATE AND LATE DISCOMFORT ARE EQUIVALENT TO THOSE SEEN AFTER UNILATERAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716396 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention