BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING SYSTEM

    MDR report key: 1882229 · Received October 20, 2010

    Report

    Report Number
    2183959-2010-00367
    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

    (B)(4).

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #218959-2010-0366; #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 #2: A (B)(6) "WOMAN WITH A PAST HISTORY OF RADICAL HYSTERECTOMY FOR CERVICAL CANCER IN 1974 AND POSTOPERATIVE ADJUVANT RADIOTHERAPY, PRESENTED TO HER GYNAECOLOGIST IN 2004 WITH SYMPTOMS OF STRESS URINARY INCONTINENCE (SUI). SHE UNDERWENT PLACEMENT OF AN INFAST SLING. POSTOPERATIVELY, SHE CONTINUED TO BE INCONTINENT AND DEVELOPED A CHRONIC VAGINAL DISCHARGE. AT THIS POINT, THE PATIENT WAS REFERRED TO OUR UNIT AND IN (B)(6) 2005, 12 MONTHS FOLLOWING INSERTION, EXAMINATION UNDER ANESTHESIA REVEALED A MESH EXTRUSION AT THE LEVEL OF THE PROXIMAL URETHRA. CYSTOSCOPY IDENTIFIED A FISTULOUS TRACT ON THE ANTERIOR BLADDER WALL ABOVE THE BLADDER NECK DISCHARGING PURULENT MATERIAL. A VAGINAL INCISION WAS MADE AND THE INFECTED INFAST SLING WAS REMOVED. THE PATIENT CONTINUED TO EXHIBIT SYMPTOMS OF SUI, VAGINAL DISCHARGE AND RECURRENT URINARY TRACT INFECTION (UTI). AN EUA AND CYSTOSCOPY SHOWED AN INTACT URETHRA AND BLADDER AND AN EXTRUSION OF THE INFAST AT THE RIGHT BLADDER NECK. THERE WAS A CHRONIC FISTULOUS TRACT LEADING TO A SMALL ABSCESS CAVITY TO THE RIGHT OF THE BLADDER NECK WITH PALPABLE MESH. THE RETROPUBIC APPROACH THROUGH A LOW CHERNEY INCISION WAS REQUIRED TO REMOVE 1 CM OF INFECTED RESIDUAL MESH ATTACHED TO THE BACK OF THE SYMPHYSIS; THE BLADDER WALL WAS THEN REPAIRED. "AT THE TIME OF WRITING THIS, THE PATIENT REPORTS AN OVERALL IMPROVEMENT IN LOWER URINARY TRACT SYMPTOMS BUT PERSISTENT STRESS URINARY 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 69 YR Hospitalization| R