BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING SYSTEM

    MDR report key: 1882273 · Received October 20, 2010

    Report

    Report Number
    2183959-2010-00368
    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; #218959-2010-0369, #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 #3: "A (B)(6) PATIENT HAD A VAGINAL REPAIR WITH INFAST SLING PERFORMED FOR STRESS URINARY INCONTINENCE (SUI). HER SUI IMPROVED CONSIDERABLY, BUT SHE DEVELOPED A CHRONIC VAGINAL DISCHARGE. A DIAGNOSIS OF DESQUAMATIVE INFLAMMATORY VAGINITIS WAS MADE, AND SHE WAS TREATED UNSUCCESSFULLY WITH REPEATED COURSE OF LOCAL CORTICOSTEROID CREAM AND ANTIBIOTICS. THREE AND HALF YEARS AFTER INSERTION OF THE SLING, SHE WAS REFERRED TO OUR UNIT WITH CHRONIC VAGINAL DISCHARGE AND IRRITATIVE BLADDER SYMPTOMS. VAGINAL EXAMINATION IN THE OUTPATIENT CLINIC WAS ESSENTIALLY NORMAL, AND IT WAS DIFFICULT TO SEE ANY OBVIOUS SIGN OF INFECTION OR DISCHARGE. VAGINAL SWABS SHOWED HEAVY GROWTH OF MIXED ANAEROBIC AND AEROBIC FLORA. EXAMINATION UNDER ANESTHESIA REVEALED A SMALL RIGHTSIDED SUBURETHRAL SINUS CONNECTED TO AN ABSCESS CAVITY EXTENDING UP INTO THE RETROPUBIC SPACE. A VAGINAL INCISION WAS MADE AND THE SINUS TRACT EXPLORED. THE SLING WAS REMOVED TRANSVAGINALLY WITH TRACTION. THE INFECTED CAVITY WAS IRRIGATED WITH GENTAMYCIN AND NORMAL SALINE. HER PAIN AND VAGINAL DISCHARGE RESOLVED POSTOPERATIVELY, THOUGH SHE EXPERIENCED A RECURRENCE OF HER STRESS INCONTINENCE."

    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 47 YR Hospitalization| R