BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH PS

    MDR report key: 629141 · Received August 24, 2005

    Report

    Report Number
    2210968-2005-00509
    Event Type
    Injury
    Date Received
    August 24, 2005
    Date of Event
    July 4, 2005
    Report Date
    July 25, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    B5: PT REPORT STRESS URINARY INCONTINENCE AND HYPERMOBILITY AND GRADE 1-2 CYSTOCELE DIAGNOSED ON 5/17/06. A SLING PROCEDURE WAS PERFORMED ON 5/30/06 TO ADDRESS THE INCONTINENCE. THE CYSTOCELE IS ASYMPTOMATIC, AND NOTHING IS TO BE DONE AT THIS TIME. THE PT IS CURRENTLY DOING WELL. ADDITIONAL INFO F-10: 1928 - NOT LABELED, 2200 - CYSTOCLE OCCURRED - NOT LABELED. H-6 CONCLUSION: IN THIS CASE, THE DEVICE PERFORMED AS INTENDED, CORRECTING THE NON-OPERATED COMPARTMENT IS A WELL DESCRIBED PROBLEM OF PROLAPSE SURGERY, OCCURRING APPROX 30% OF THE TIME. IN THIS CASE, THE POSTERIOR COMPARTMENT UNDERWENT PROLIFT, WHILE THE ANTERIOR COMPARTMENT DID NOT, AND ULTIMATELY THE PT DEVELOPED A CYSTOCELE AND SUI. APPARENTLY THE CYSTOCELE IS ASYMPTOMATIC AS THE PT IS TO UNDERGO A SLING FOR THE SUI WITH NO CORRECTION OF THE CYSTOCELE. AT ANY RATE, THE PROBLEM IS NOT DEVICE RELATED NOR IS THE FURTHER INTERVENTION. PELVIC FLOOR REPAIR WITH GYNEMESH IS NOT INTENDED TO TREAT OR PREVENT URINARY INCONTINENCE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT PELVIC SURGERY IN 2004. IN ABOUT ONE YEAR LATER, THE PATIENT'S FAMILY MEMBER WAS ABLE TO FEEL THE MESH. DURING EXAMINATION IN ABOUT 3 WEEKS LATER, A 3 X 2 MM MESH EXPOSURE WAS NOTED. ESTROGEN VAGINAL CREAM HAS BEEN PRESCIBED AND THE MESH WILL BE SURGICALLY RESECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA JCG03265

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention