BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON GYNECARE TVT TAPE

    MDR report key: 1152044 · Received September 5, 2008

    Report

    Report Number
    MW5008230
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    October 26, 2005
    Report Date
    September 5, 2008
    Manufacturer
    ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS A VERY BRIEF OUTLINE OF MY EVENTS ON THIS HORRENDOUS TENSION FREE VAGINAL TAPE SURGERY. SEEN GYNY FOR STRESS INCONTINENCE, HAD ALL TESTS TO CONFIRM STRESS CONTINENCE, ADVISED TO HAVE THE TVT PLUS MARINA COIL AT SAME TIME DUE TO HEAVY PERIODS AND NEW CONTRACEPTION METHOD, I WAS TOLD THIS IS A SIMPLE OPERATION WITH AN OVERNIGHT STAY. I WAS NOT GIVEN ANY INFO ON RISKS AND COMPLICATIONS ASSOCIATED WITH THIS TYPE OF SURGERY. TWO WEEKS PRIOR TO MY OPERATION, I HAD AN ASSESSMENT AND CLAIMED FIT FOR SURGERY, SIGNED THE CONSENT FORM TO PROCEED WITH SURGERY. DAY OF SURGERY, ALL PREPPED UP FOR OPERATION. VERY RESTLESS NIGHT, COULD NOT SLEEP. IN THE MORNING, COULD NOT BREATHE PROPERLY AND FELT VERY WEAK. WAS TAKEN FOR A SHORT WALK, COLLAPSED IN HALLWAY, TAKEN BACK TO BED. ANNOUNCED I HAVE GOT A PULMONARY EMBOLUS (CLOTS ON THE LUNGS) PLUS A COLLAPSED LEFT LUNG. PUT ON OXYGEN, HEPARIN, THEN ONCE STABLE WARFARIN. SENT HOME, MONTHS OF CONTINUOUS BLEEDING, THOUGHT IT COULD BE THE MARINA COIL HAD IT REMOVED. STILL BLEEDING EVERY MONTH ONLY MORE SEVERE, BLEEDING CAN BE DESCRIBED AS POURING EVERY MONTH FOR MINIMUM 5 DAYS THEN DYING OFF TO HEAVY BLEED CAN LAST UP TO 2 WEEKS, WEAKNESS, PAIN IN LOWER ABDOMEN, LOWER BACK AND RIGHT BUTTOCK. PLUS 2 MONTHS AFTER THE OPERATION, DIAGNOSED WITH DIABETES TYPE 2. SUFFERED SLURRED SPEACH, CONTINUOUS WEAKNESS, EXTREME TIREDNESS, AFTER LENTHGY TESTS DURING THE NEXT 2 YEARS AND STILL ONGOING TO THIS DAY MRI'S, SCANS, CONTINUOUS BLOOD TESTS, APPOINTMENTS ON AVERAGE MONTHLY, NEAR ON 2 YEARS AFTER OPERATION DIAGNOSED WITH MYASTHENIA GRAVIS -SEVERE MUSCLE WEAKNESS. MESH EROSION HAS NOW APPEARED RECENTLY AND DO NOT KNOW AT THIS STAGE FULL EXTENT OF DAMAGE TO VAGINAL WALL, POSSIBLE BLADDER EROSION TOO. THIS TVT TAPE SURGERY HAS DESTROYED MY LIFE, NOT ONLY MINE BUT HAS EFFECTED MY IMMEDIATE FAMILY. TO THIS DAY, I OCCASIONALLY SUFFER WITH BLOOD IN THE URINE, CONSTIPATION, SEVERE AND SOMETIMES POURING VAGINAL BLEEDING, WEAKNESS, EXTREME TIREDNESS, THE LIST IS ENDLESS!. I URGE YOU TO PLEASE GET THIS PRODUCT OFF THE MARKET. THERE ARE MANY, MANY PEOPLE SUFFERING HUGE COMPLICATIONS, DISABILITIES, AND LIFE THREATENING SITUATIONS TO REMOVE THIS AWFUL TAPE FROM OUR BODIES. SOME NEVER CAN HAVE IT REMOVED AS THE RISKS ARE TOO HIGH FOR SURGERY OR RISKS WILL MAKE MATTERS WORSE FOR THE PT. DATES OF USE: 2005 - 2008. DIAGNOSIS OR REASON FOR USE: STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON GYNECARE TVT TAPE TENSION FREE VAGINAL TAPE FTL ETHICON 830041B 1323093

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R