BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7730150 · Received July 29, 2018

    Report

    Report Number
    2210968-2018-74709
    Event Type
    Injury
    Date Received
    July 29, 2018
    Report Date
    July 13, 2018
    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

    PC-000236008 DATE SENT TO THE FDA: 07/29/2018 ADDITIONAL PATIENT CODES:

    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: INT UROGYNECOL J; DOI 10.1007/S00192-009-0879-9. (B)(4)

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLE : COMPLICATIONS OF TRANSVAGINAL MONOFILAMENT POLYPROPYLENE MESH IN PELVIC ORGAN PROLAPSE REPAIR. THIS RETROSPECTIVE CASE SERIES AIMED TO DOCUMENT THE INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS ASSOCIATED WITH THE USE OF TRANSVAGINAL POLYPROPYLENE MESH IN THE REPAIR OF POP FROM ONE SURGEON. BETWEEN SEP2005 AND JUL2007, 127 FEMALE PATIENTS (MEAN AGE SD OF 63.5±10.2 YEARS) UNDERWENT VAGINAL RECONSTRUCTIVE SURGERY FOR ANTERIOR, POSTERIOR, AND APICAL PROLAPSE CORRECTION REINFORCED BY MONOFILAMENT POLYPROPYLENE MESH. IN THE PROCEDURE, A TRAPEZOID PIECE OF GYNECARE POLYPROPYLENE MESH (ETHICON) IN THE RECONSTRUCTION (ANTERIOR [N=74], POSTERIOR [N=27] AND COMBINED ANTERIOR-POSTERIOR [N=26]). POSTOPERATIVE COMPLICATIONS INCLUDED DE NOVO URINARY INCONTINENCE (N=23) FOR WHICH 16 REQUIRED FURTHER SURGERY OF SUBURETHRAL SLINGS, MESH EROSION (N=13) WHICH 11 REQUIRED FURTHER SURGERY, PROLAPSE IN ANY PELVIC COMPARTMENT (N=9) FOUR OF THEM REQUIRED REPAIR, VAGINAL HEMATOMA (N=7) WHICH WERE MANAGED CONSERVATIVELY AND RESOLVED IN 6-8 WEEKS WITHOUT ANY SURGICAL MEASURES, URINARY TRACT INFECTION (N=5), VAGINAL DISCHARGE (N=1), VISCERAL EROSION (N=1), GRANULATION TISSUE (N=1) AND FEBRILE MORBIDITY (N=1).THE POSTERIOR WALL MESH MAY HAVE PRODUCED PROLAPSE IN UNINVOLVED COMPARTMENT WHEN COMBINED WITH APICAL SUPPORT PROCEDURES. THE POSTOPERATIVE BUTTOCKS PAIN WAS ASSOCIATED WITH SACROSPINOUS LIGAMENT FIXATION. CONCURRENT VAGINAL HYSTERECTOMY IS ASSOCIATED WITH INCREASED RISK OF VAGINAL MESH EROSION. COMBINED ANTERIOR AND POSTERIOR VAGINAL MESH REPAIR IS AN INCREASED RISK FACTOR FOR INTRAOPERATIVE BLEEDING AND BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571940 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention