BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT SLING

    MDR report key: 1210945 · Received October 23, 2008

    Report

    Report Number
    MW5008749
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    December 14, 2005
    Report Date
    October 23, 2008
    Manufacturer
    JOHNSON & JOHNSON GYNA CARE
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN LATE 2005, I HAD A TVT SLING PUT IN. ON MY FOUR WEEK CK UP RIGHT ARTERY SURGERY, IT HAD ALREADY ERODED INTO MY VAGINA. I HAD CONSTANT PAIN, ESPECIALLY DURING URINATION. SEX WAS OUT OF THE QUESTION. THE DR SAID THEY CANT BE REMOVED. THEY ARE THERE TO STAY. FOR TWO YEARS. I HAD PAIN AND MISERY. IN 2008, I SAW MY DR.. TOLD HER PAIN WAS SO BAD.. SHE LOOKED INSIDE MY BLADDER AND I WATCHED ON TH SCREEN. IT HAD ERODED INTO MY BLADDER, WAS TANGLED IN A MESS OF TISSUES AND STONES HAD FORMED BECAUSE IT HAD BEEN IN THERE FOR SO LONG. ON THE FOLLOWING MONTH, THEY WENT IN AND TOOK OUT THE NET THAT WAS IN MY BLADDER AND IN MY VAGINA. I STILL HAVE SOME NET LEFT IN ME. MY DR SAID IT WOULD BE TOO DANGEROUS TO REMOVE IT. IT WAS A LITTLE OVER FOUR HOUR SURGERY. I WAS IN THE HOSPITAL FOR SIX DAYS WHEN THEY TOOK THE STAPLES OUT, I REOPENED UP 3 1/2 ON MY RIGHT SIDE. I AM STILL OPEN BUT IT IS CLOSING SLOWLY. THIS WAS THE WORST SURGERY I HAVE EVER HAD. MY DR TOLD ME SINCE IT ERODED SO QUICKLY FIRST INTO MY VAGINA THEN INTO MY BLADDER THAT I WILL MORE THAN LIKELY HAVE FUTURE SURGERIES. MY DR FEELS IT WILL ERODE AGAIN SOMEWHERE. I AM HOPING YOU CAN DO SOMETHING TO HELP OTHERS BEFORE THEY HAVE THIS TERRIBLE SURGERY. I AM NOW IN CONSTANT PAIN. I HAVE NUMBNESS IN MY LEFT LEG WITH SHOOTING PAINS. I HAVE STOMACH AND VAGINAL PAIN. MY LIFE SINCE 2005 HAS CHANGED SO MUCH THAT NOW I AM NOT LIVING, ONLY EXISTING. THANK YOU. DIAGNOSIS OR REASON FOR USE: TO HELP BLADDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVT SLING TVT SLING FTL JOHNSON & JOHNSON GYNA CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R