BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING SYSTEM

    MDR report key: 1882272 · Received October 20, 2010

    Report

    Report Number
    2183959-2010-00366
    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 #218959-2010-0367; #218959-2010-0368; #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 #1: PATIENT WAS IMPLANTED WITH AN INFAST SLING FOR THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI). "THE PATIENT REPORTED RESOLUTION OF HER SUI SYMPTOMS FOLLOWING THE PROCEDURE. FOUR YEARS POSTOPERATIVELY, THE PATIENT DEVELOPED A PERSISTENT BLOOD STAINED VAGINAL DISCHARGE, WHICH NECESSITATED A CHANGE OF PADS 2-3 TIMES A DAY. THE PATIENT DENIED ANY HISTORY OF MENSTRUAL IRREGULARITIES SINCE THE INSERTION OF A DEVICE LNG-IUD 2 YEARS PREVIOUSLY." IN AN INITIAL EFFORT TO ALLEVIATE HER SYMPTOMS THE IUD WAS REMOVED. THE VAGINAL DISCHARGE PERSISTED. "CLINICAL EXAMINATION REVEALED NO ABNORMALITY. VAGINAL SWABS REVEALED UREAPLASMA UREALYTICUM, MIDSTREAM URINE CONFIRMED AN ESCHERICIA COLI URINARY TRACT INFECTION". SHE WAS TREATED. "THE PATIENT THEN UNDERWENT A DIAGNOSTIC LAPAROSCOPY, HYSTEROSCOPY AND CYSTOSCOPIC, CONFIRMING NORMAL ANATOMY WITH NO IDENTIFIABLE CAUSE FOR HER PERSISTENT VAGINAL DISCHARGE OR URINARY FISTULA. MAGNETIC RESONANCE IMAGING OF THE RETROPUBIC SPACE AND ANTERIOR VAGINA REVEALED A PINHOLE COMMUNICATION BETWEEN MESH AND THE VAGINAL MUCOSA, CLOSE TO THE LEVEL OF BLADDER NECK. IT CONFIRMED THE CLINICAL SUSPICION OF A CHRONIC INFECTION IN THE VICINITY OF THE MESH LEADING TO A CHRONIC VAGINAL DISCHARGE. THE PATIENT UNDERWENT REMOVAL OF THE SILICONE-COATED MESH IN TOTO VIA A COMBINED ABDOMINAL/VAGINAL PROCEDURE. THE PATIENT MADE A FULL RECOVERY FROM THE PROCEDURE AND AT 3-MONTHS REVIEW, THERE WAS NO RECURRENCE OF THE VAGINAL DISCHARGE OR SUI."

    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 39 YR Hospitalization| R