BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TENSION-FREE VAGINAL TAPE-OBTURATOR SYSTEM

    MDR report key: 1153526 · Received September 8, 2008

    Report

    Report Number
    MW5008246
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    April 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    GYNECARE, JOHNSON & JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GYNECARE TVT-O WAS PUT IN AT THE WRONG ANGLE AND TOO TIGHT CAUSING EXTREME PAIN WITHIN THE VAGINA AND AT THE URETHRA. IMMEDIATELY AFTER SURGERY, BUTTOCK AND BACK OF THIGH PAIN WAS NOTED. WALKING CAUSED SUN-BURN LIKE PAIN DOWN INSIDE OF THIGHS AND SHARP PAIN IN CREASE OF THE THIGH. SITTING WAS IMPOSSIBLE FOR LONGER THAN 5 MINUTES AT A TIME. LOWER BACK PAIN PRESENTED WHEN STANDING OR BENDING. MOST OF THE TAPE WAS REMOVED IN 2008. THE ENDS OF THE TAPE REMAIN AND HAVE BEEN TOLD IT CANNOT BE REMOVED WITHOUT A "VERY PAINFUL AND DELICATE" OPERATION WHERE NO GUARANTEE CAN BE MADE TO EASE CURRENT PAIN, SITTING OR WALKING DIFFICULTIES AND THE POSSIBILITY THAT FURTHER DAMAGE CAN OCCUR. CURRENTLY WHEN WALKING OR SITTING SHARP PAIN CAN BE FELT IN CREASE OF THIGHS. VARIOUS PELVIC PAINS PRESENT AT ODD TIMES WITHOUT CAUSE OR EXPLANATION. REPEATED UTI'S AND VAGINAL INFECTIONS REQUIRED HEAVY DOSES OF ANTIBIOTICS. STRESS INCONTINENCE HAS RETURNED AND URGE INCONTINENCE NOW PRESENT TOO. FLOW PATTERN AND STREAM STRENGTH HAS CHANGED DRAMATICALLY. BOTOX AND LIDOCAINE INJECTIONS, INTERNAL AND EXTERNAL PHYSICAL THERAPIES HAVE DONE NOTHING TO REDUCE SYMPTOMS, IT AGGRAVATES THEM. DEEP PELVIC ACHES ARE CONSTANT. THE BODY SEEMS TO BE REJECTING THE POLYPROPYLENE MESH AND SUTURES. DOCTORS PERFORMING THIS TYPE OF PROCEDURE MUST BE VERY WELL TRAINED. MOST ARE NOT. MANY HAVE NO HANDS ON EXPERIENCE AT ALL. THERE NEEDS TO BE A WAY TO TEST A PERSON'S TOLERANCE TO POLYPROPYLENE BEFORE IT IS INSERTED INTO THE BODY. MOST WERE TOLD THIS WAS A MINIMALLY INVASIVE, 30 MINUTE PROCEDURE. MOST WERE NOT TOLD OF THE POSSIBLE LIFE-ALTERING SIDE EFFECTS. MORE TESTING NEEDS TO BE DONE BEFORE MORE PEOPLE, WOMEN AND MEN, ARE DISABLED BY THIS MATERIAL AND THE PROCEDURE USED TO INSERT IT. PRODUCT NAMES AND THERAPY DATES: 2008 - PELVIC PT, EXTERNAL TWELVE DAYS LATER - PELVIC EXAM: THE FOLLOWING MONTH - BOTOX & LIDOCAINE INJECTIONS - THREE DAYS LATER - PELVIC PT, EXTERNAL TWELVE DAYS LATER - PELVIC PHYS, FIRST EXAM THE FOLLOWING DAY - PELVIC PT, INTERNAL, VAGINAL/RECTAL SENSOR TWO DAYS LATER - PELVIC PT, EXTERNAL THE FOLLOWING MONTH - PELVIC PT, EXTERNAL THREE DAYS LATER - PELVIC PT, INTERNAL, VAGINAL/RECTAL SENSOR. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: STRESS URINARY INCONTINENCE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TENSION-FREE VAGINAL TAPE-OBTURATOR SYSTEM SUB-URETHRAL SLING FTL GYNECARE, JOHNSON & JOHNSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R| S