BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAGINAL MESH

    MDR report key: 2190719 · Received July 29, 2011

    Report

    Report Number
    MW5021572
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    October 5, 2010
    Report Date
    July 29, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD HYSTERECTOMY, CYSTOCELE AND RECTOCELE REPAIR. POST SURGERY, I HAD BACK PAIN FROM DAY 1. IT HAS NEVER STOPPED AS I WAS TOLD IT WOULD. THE VAGINAL MESH HAS PROTRUDED THROUGH MY VAGINAL WALL. IT WAS TRIMMED IN THE OFFICE IN (B)(6) 2011. I HAVE A CONSTANT DRAINAGE AND HAVE BEEN ON ATB A TIME OR TWO FOR INFECTIONS. I AM NOW TOLD AS LONG AS THE MESH PROTRUDES THROUGH THE WALL, I WILL ALWAYS HAVE INCREASED WBC IN MY VAGINA AND ONLY NEED ATB IF FOUL ODOR OCCURS. I HAVE DAILY DRAINAGE AND NEED PANTY LINERS. I WAS TOLD THE PAIN I HAVE IS NOT RELATED TO MY SURGERY. TO GO TO MY GP. I DID AND I HAD A 5000.00 CT SCAN THAT SHOWED NOTHING. I WAS GIVEN PROTONIX OVER 2 MONTHS AGO AND STILL HAVE PAIN. MY LOWER PELVIC PAIN WAS CONSTANT DAILY CRAMP, THAT HAS NOW TURNED INTO SHARP STABBING PAINS. SEX IS PAINFUL AND I DON'T HAVE IT. AS IT CAUSES THE MESH TO PROTRUDE MORE OUT OF VAGINAL WALL AND INCREASE VAGINAL DRAINAGE. I WENT BACK TO MY OB DOCTOR AND AM TOLD THAT POSSIBLE ADHESIONS HAVE ADHERED TO MY COLON, EXPLORATORY SURGERY WOULD ONLY TELL. THEY (OB DOCTOR) ALSO SAID I WOULD PROBABLY NEED ESTROGEN CREAM, TO HELP HEAL - CLOSE VAGINAL INCISION SITE OF PROTRUDING MESH IN MY VAGINA. AND POSSIBLE GENERAL ANESTHESIA/LOCAL AT VAGINA TO TRIM THE PROTRUDING MESH THAT IS SHOWING NOW. ONLY PROBLEM IS THE MESH COMES OUT FARTHER IF I HAVE INTERCOURSE. SO I DON'T HAVE INTERCOURSE. IT DID NOT HEAL THE FIRST TIME THEY TRIMMED IT AND NO SEX FOR 3 WEEKS, THEN ONLY FOR 2 WEEKS LATER FIND THE MESH AND VAGINAL CUFF WIDER AND MESH 1/4 INCH PROTRUDING, NO SEX NOW FOR 4 WEEKS, MESH HAS GONE BACK IN SOME. BUT VAGINAL CUFF INCISION IS STILL WIDER. I FIND OUT YOU COULD USE A SKIN GRAFT OR PIG SKIN TO SLING MY BLADDER. BUT ONLY AFTER HAVING COMPLICATIONS AND DOING MY OWN RESEARCH. WHY WAS NOT ANY OF THIS ADVISED TO ME? I FEEL THIS MESH, AFTER MY RESEARCH, IS NOT GOOD FOR PUBLIC OR POST SURGERY RELATIONSHIPS. TRANSVAGINAL MESH PLACED DURING SURGERY ON (B)(6) 2011 BY DR (B)(6), NO INFO ON PRODUCT PLACED WAS GIVEN TO ME AND PT IS FILLING OUT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAGINAL MESH VAGINAL MESH FTL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other