BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING SYSTEM

    MDR report key: 1882276 · Received October 20, 2010

    Report

    Report Number
    2183959-2010-00369
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    October 4, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INT UROGYNECOL J PUBLISHED ONLINE 09/03/2010. DOI 10.1007/S00192-0101244-8EPUB.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #218959-2010-0366; #218959-2010-0367; #218959-2010-0368; 218959-2010-0370. MAGAZINE ARTICLE INDICATED FOUR OF FIVE PATIENTS PRESENTING WITH SYMPTOMS OF CHRONIC VAGINAL DISCHARGE, ONE PRESENTING WITH IRRITATIVE VOIDING SYMPTOMS AND BLADDER PAIN. RESOLUTION OF PRESENTING SYMPTOMS REQUIRED TOTAL REMOVAL OF THE SILICONE-COATED POLYESTER MESH SLING. THE CONCLUSIONS WERE THAT "THE SILICONE-COATED MESH OF THE AMS INFAST SLING, CAN BECOME A FOCUS FOR CHRONIC INFECTION FORMING A SINUS TRACT INTO THE VAGINA OR OTHER VISCUS, CAUSING SYMPTOMS YEARS AFTER ITS PLACEMENT." CASE #4: "A (B)(6) WOMAN WITH A PAST HISTORY OF A VAGINAL AND RECTAL PROLAPSE REPAIR HAD AN INFAST SLING AND ANTERIOR VAGINAL REPAIR IN (B)(6) 2005. POSTOPERATIVELY, SHE HAD VOIDING DIFFICULTY, WHICH SUBSEQUENTLY IMPROVED, ALTHOUGH SHE THEN DEVELOPED URINARY FREQUENCY, URGENCY AND BLADDER PAIN. A CYSTOSCOPY PERFORMED 2 MONTHS LATER REVEALED EROSION OF THE SLING INTO THE BLADDER. THE MESH WAS REMOVED ABDOMINALLY AND THE BLADDER WAS REPAIRED. HER IRRITATIVE BLADDER SYMPTOMS AND BLADDER PAIN RESOLVED POSTOPERATIVELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFAST SLING SYSTEM INTEMESH SILICONE-COATED SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 72403281 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R