BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT SURE

    MDR report key: 2171277 · Received July 14, 2011

    Report

    Report Number
    MW5021384
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    September 1, 2006
    Report Date
    July 14, 2011
    Manufacturer
    NOT SURE
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD VAGINAL AND RECTAL PROLAPSE AFTER DELIVERING THREE BABIES. I HAD MY INITIAL SURGERY IN 2006 WITH A HYSTERECTOMY OF MY UTERUS AND HAD MESH IMPLANTED TO BASICALLY HOLD UP MY ORGANS FROM PROLAPSING THROUGH MY VAGINA AND RECTUM AS WELL AS A BLADDER SLING FOR INCONTINENCE. SINCE THE INITIAL SURGERY I HAVE HAD TWO "REPAIR" SURGERIES FOR MESH EROSION. I HAVE ALSO SUFFERED NUMEROUS URINARY TRACT INFECTIONS. I HAVE DEVELOPED RESISTANCE TO ALMOST ALL ORAL ANTIBIOTICS, I SEE AN INFECTIOUS DISEASE DOCTOR NOW FOR TREATMENTS OF THE UTI'S, HAVE BEEN TREATED WITH PAINFUL ANTIBIOTIC INJECTIONS AS WELL AS IV ANTIBIOTICS WITH NUMEROUS TRIPS TO THE ER. THE INFECTIONS DISEASE DOCTOR FEELS THAT THE MESH/SLING IS THE ROOT CAUSE OF MY INFECTIONS. HIS RECOMMENDATION IS TO HAVE THE MESH REMOVED, NOT EASILY DONE SINCE IT HAS GRAFTED INTO MY TISSUE, REMOVAL WOULD LEAVE ME INTERNALLY DISFIGURED (MORBIDITY), ALSO SUFFER PAINFUL INTERCOURSE, PELVIC PAIN, URINARY RETENTION AND LEAKAGE. I DID NOT KNOW UNTIL RECENTLY AFTER RESEARCHING THE VAGINAL MESH AND SLINGS ONLINE THAT THERE ARE A BUNCH OF LAW FIRMS NATIONWIDE GATHERING CLIENTS FOR A CLASS ACTION LAWSUIT AGAINST THE MFRS OF THE MESH/SLING. MY DOCTORS NEVER MENTIONED THIS TO ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT SURE VAGINAL MESH AND SLING FTL NOT SURE NOT SURE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Congenital Anomaly| H| L| O| R| S