BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7469232 · Received April 27, 2018

    Report

    Report Number
    2210968-2018-72395
    Event Type
    Injury
    Date Received
    April 27, 2018
    Report Date
    April 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TITLE: SUBURETHRAL SLINGPLASTY USING A SELF-FASHIONED GYNEMESH FOR TREATING URINARY INCONTINENCE AND ANTERIOR VAGINAL WALL PROLAPSE AUTHORS: CHI-FENG SU, SOO-CHEEN NG, KWONG-PANG TSUI, GIN-DEN CHEN, HORNG-JYH TSAI CITATION: TAIWAN J OBSTET GYNECOL. 2009; 48(1). IN THIS PROSPECTIVE STUDY, THE AUTHORS AIMED TO EVALUATE THE EFFECTIVENESS OF THE SELF-FASHIONED MESH FOR THE CONCOMITANT TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI) AND PELVIC ORGAN PROLAPSE, AND THE FACTORS ASSOCIATED WITH MESH EROSION. A TOTAL OF 65 PATIENTS WITH URINARY INCONTINENCE, WITH OR WITHOUT PELVIC ORGAN PROLAPSE OR PRIOR SURGERY FOR PROLAPSE OR INCONTINENCE UNDERWENT SUBURETHRAL SLINGPLASTY AND/OR CONCOMITANT PELVIC RECONSTRUCTIVE OPERATIONS AND WERE INCLUDED IN THE STUDY. BEFORE THE PUBOVAGINAL SLING (PVS) PROCEDURE, A SELF-FASHIONED MESH WAS PREPARED BY TRIMMING THE GYNEMESH AND SEWING IT WITH VICRYL 1-0 SYNTHETIC ABSORBABLE SUTURES ALONG BOTH ENDS. THE TIP OF THE NEEDLE WAS ADVANCED INTO THE TUNNEL BETWEEN THE PUBOURETHRAL LIGAMENT AND THE UNDERLYING VAGINAL MUCOSA, THREADED WITH VICRYL 1-0 SUTURE AND WITHDRAWN FROM THE SUPRAPUBIC INCISION. THE VICRYL 1-0 SUTURE WAS PULLED UNTIL THE EDGE OF THE ATTACHED GYNEMESH PASSED THROUGH THE ENDOPELVIC FASCIA, AND IT WAS THEN ANCHORED INTO THE ARCUS TENDINEUS FASCIA PELVIS. THE PROCEDURE WAS REPEATED ON THE OTHER SIDE. THE GYNEMESH WAS PLACED WITHOUT TENSION UNDERNEATH THE BLADDER NECK AND PROXIMAL URETHRA AS WELL AS THE SUPPORTING PART OF THE ANTERIOR VAGINAL WALL. REPORTED COMPLICATIONS INCLUDED URINARY TRACT INFECTION (N-3) WHICH REQUIRED ORAL ANTIBIOTICS AND VAGINAL MESH EROSION IN A (B)(6)-YEAR-OLD FEMALE AT 6 MONTHS POST-OPERATIVELY WITH MECHANICAL REJECTION DUE TO FOLDED MESH AND (B)(6)-YEAR-OLD FEMALE AT 22 MONTHS POST-OPERATIVELY DUE TO CHRONIC INFLAMMATION AND POOR VAGINAL MUCOSAL STATUS ESTROGEN DEFICIENCY IN WHICH THE EXPOSED VAGINAL MESH WAS REMOVED. THE AUTHORS REPORTED THAT THE OTHER CASES OF VAGINAL MESH EROSION IN A (B)(6)-YEAR-OLD FEMALE AT 1 MONTH POST-OPERATIVELY AND (B)(6)-YEAR-OLD FEMALE AT 5 MONTHS POST-OPERATIVELY WERE DUE TO OVER-TRIMMED SUBURETHRAL MUCOSA AND POOR VAGINAL MUCOSA STATUS DUE TO ESTROGEN DEFICIENCY, AND WEAKENING AND OVER-DISSECTING OF THE LATERAL RECESS OF THE VAGINA AND POOR VAGINAL MUCOSAL STATUS ESTROGEN DEFICIENCY, RESPECTIVELY. IT WAS CONCLUDED THAT USING A SELF-FASHIONED GYNEMESH FOR SUBURETHRAL AND ANTERIOR VAGINAL SLINGPLASTY WITH A TENSION-FREE PROCEDURE CAN PROVIDE A HIGH SUCCESS RATE FOR TREATING URINARY INCONTINENCE ASSOCIATED WITH ANTERIOR VAGINAL WALL PROLAPSE. HOWEVER, MECHANICAL REJECTION MAY BE ONE OF THE CAUSES OF VAGINAL MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311243 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention