BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSVAGINAL MESH

    MDR report key: 2423589 · Received January 12, 2012

    Report

    Report Number
    MW5023832
    Event Type
    Other
    Date Received
    January 12, 2012
    Date of Event
    December 31, 2009
    Report Date
    January 12, 2012
    Manufacturer
    UNK
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD RECEIVED HERNIA SURGERY ON (B)(6) 2009 ON MY LOWER RIGHT MUSCLE THAT HOLDS MY UTERUS USING TRANSVAGINAL MESH TO REPAIR. IN (B)(6) 2011, I STARTED FEELING SHARP PAINS IN MY GROIN AREA. I WENT TO MY OB FOR MY ANNUAL AND DURING THIS TIME THEY RAN BASIC PHYSICAL TESTS. ON THESE TESTS THEY DISCOVERED THAT I HAD A VERY HIGH WHILE BLOOD CELL COUNT AND BLOOD IN MY URINE. IT WAS VERY PAINFUL DURING THE EXAMINATION FOR THEM TO EXAMINE ME THOROUGHLY DUE TO THE SHARP PAIN. MY OB PRESCRIBED ANTIBIOTICS AND ASKED ME TO COME BACK IN A WEEK TO RE-RUN TESTS. THE RESULTS WERE THE SAME. AFTER THIS VISIT, I WAS REFERRED TO AN UROLOGIST SINCE THE BLOOD WAS STILL PRESENT IN MY URINE. THE UROLOGIST RAN SEVERAL TESTS OVER A ONE MONTH PERIOD AND WAS NOT ABLE TO FIND ANYTHING THAT WAS CAUSING EITHER THE PAIN NOR THE BLOOD IN MY URINE. HE THEN REFERRED ME BACK TO THE SURGEON WHO HAD CONDUCTED MY SURGERY IN 2009. BY THIS TIME, IT WAS (B)(6) 2011. AFTER VISITING MY SURGEON HE DID NOT THINK THAT IT WAS ANOTHER HERNIA BUT IT WAS A PINCHED NERVE UNDER THE MESH. HE THEN REFERRED ME TO A PAIN MANAGEMENT FACILITY. IN THIS FACILITY I HAVE BEEN SEEN BY 2 MORE DOCTORS AND HAVE UNDER GONE OVER 25 INJECTIONS OF PAIN MEDICINE, 2 NERVE BLOCKS, 3 MONTHS OF PHYSICAL THERAPY, 4 DIFFERENT NERVE BLOCKING DRUGS, 2 NERVE BURN PROCEDURES (5 TOTAL NERVES), AND PAIN MEDICINE. MY LAST NERVE BURN WAS ON (B)(6) 2011. AS OF TODAY, I STILL HAVE PAIN IN MY GROIN AREA BUT NOW IT HAS GONE DOWN THE INSIDE OF MY RIGHT LEG AND UP ON MY RIGHT HIP ALONG THE SURGICAL SCAR AND BELOW WHERE THE MESH SITS. WE ARE NOT SURE WHERE ELSE TO TURN AND FELT THAT THIS IS INFORMATION THAT THE FDA SHOULD BE AWARE OF. I UNDERSTAND THAT THERE ARE SEVERAL CASES REGARDING THIS ISSUE. I WAS FEELING DISCOURAGED WITH A YEAR OF PAIN SINCE IT EFFECTS EVERYTHING THAT I DO; FAMILY, WORK, OR EVEN SIMPLE TASKS LIKE SITTING OR STANDING. I WENT ONLINE AND READ SEVERAL OTHER STORIES SIMILAR TO MINE AND IT MADE ME BETTER THAT I AM NOT ALONE. I AM REPORTING THIS TO YOU SO OTHERS KNOW WHAT THEY TOO ARE NOT ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVAGINAL MESH TRANSVAGINAL MESH FTL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other