BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING SYSTEM

    MDR report key: 1882230 · Received October 20, 2010

    Report

    Report Number
    2183959-2010-00370
    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

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #218959-2010-0366; #218959-2010-0367; #218959-2010-0368; 218959-2010-0369. 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 #5. A (B)(6) WOMAN HAD AN INFAST SLING SURGERY FOR STRESS URINARY INCONTINENCE. "TWO MONTHS LATER, VAGINAL EXAMINATION REVEALED MESH EXPOSURE WHICH WAS EXCISED AND VAGINA WAS RESUTURED UNDER GENERAL ANESTHESIA. HOWEVER, HER SYMPTOM OF VAGINAL DISCHARGE CONTINUED. SIXTEEN MONTHS POSTOPERATIVELY, SHE DEVELOPED VAGINAL BLEEDING AND A GRANULOMATOUS VAGINAL POLYP WAS REMOVED. IN YEAR 3 AND 4, SHE DEVELOPED VAGINAL INFECTIONS AND WAS TREATED WITH REPEATED COURSE OF ANTIBIOTICS TOGETHER WITH REMOVAL OF VAGINAL POLYPS BY SILVER NITRATE. SEVEN AND A HALF YEARS LATER, SHE WAS REFERRED TO AN ORTHOPAEDIC SURGEON WHO REMOVED THE MESH AND SUTURES WITH INFAST SCREWS VIA A SYMPHYSIOTOMY. HER ONGOING SYMPTOMS OF VAGINAL DISCHARGE AND IRRITATIVE BLADDER SYMPTOMS RESOLVED, FOLLOWING THE SUCCESSFUL REMOVAL OF THE MESH."

    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 53 YR Hospitalization| R