BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7594469 · Received June 12, 2018

    Report

    Report Number
    2210968-2018-73429
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    May 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WEB ADDRESS: DOI 10.1007/S00192-007-0539-X (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: THE USE OF POLYPROPYLENE MESH AS A TRANSOBTURATOR SLING FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (EARLY EXPERIENCE WITH 40 CASES)" AUTHOR : ABDELNASER K. H. ELGAMASY & OSAMA M. ELASHRY & MOHAMMED A. ELENIN & HASSAN H. ELTATAWY & MAHMOUD D. ELSHARABY WEB ADDRESS: DOI 10.1007/S00192-007-0539-X THE AIM OF THIS STUDY IS TO PRESENT WAS TO EVALUATE THE USE OF TRADITIONAL POLYPROPYLENE MESH, USE IN HERNIA REPAIRS, AS A SLING IN THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI). FROM DEC2004 TO MAY2006, 40 FEMALE PATIENTS (AGES 28 TO 55 YEARS [40.8±7.8 YEARS]) WITH SUI UNDERWENT TRANSOBTURATOR SLING FASHIONED FROM VYPRO II MESH. PURE SUI WAS FOUND IN 27 (67.5%) AND MIXED INCONTINENCE IN 13 PATIENTS (32.5%). DURING THE PROCEDURE, THE TWO ENDS OF THE PROLENE SUTURES OF THE SLING WERE INSERTED THROUGH THE EYE OF THE TIP OF THE NEEDLE AND GUIDED BACK TO THE OBTURATOR INCISION. THE SAME TECHNIQUE WAS PERFORMED AT THE OTHER SIDE. THE SLING WAS ADJUSTED WITHOUT ANY TENSION, AND THE EXCESS LENGTH WAS CUT OFF AT THE OBTURATOR INCISION. EACH LATERAL END OF THE SLING WAS SECURED BY A ZERO PROLENE SUTURE. EARLY POSTOPERATIVE VOIDING DIFFICULTY WAS NOTED IN 5 PATIENTS WHERE 3 OF THESE RESUMED NORMAL VOIDING WITHIN 2 WEEKS AND 2 HAD PERSISTENT VOIDING DIFFICULTY WHICH WAS MANAGED BY CLEAN INTERMITTENT CATHETERIZATION (CIC). VAGINAL INFECTIONS WERE RECORDED IN 4 PATIENTS AND WERE MANAGED BY ANTIBIOTICS AND VAGINAL HYGIENE MEASURES. DYSPAREUNIA WAS RECORDED IN SIX PATIENTS (15%); LATER ON, THREE OF THEM DEVELOPED VAGINAL EROSION PRESENTING WITH VAGINAL PAIN, DYSPAREUNIA, AND PURULENT VAGINAL DISCHARGE, AND SLINGS WERE REMOVED. OUT OF 13 PATIENTS WITH MIXED INCONTINENCE, 3 OF THEM HAD PERSISTENT DETRUSOR INSTABILITY AND REQUIRED ANTICHOLINERGICS, WHILE 3 OUT OF 27 PATIENTS WITH PURE SUI DEVELOPED DE NOVO DETRUSOR INSTABILITY WHICH IMPROVED WITHIN ONE MONTH UNDER FOLLOW-UPS. THE BEST WAY TO AVOID VAGINAL BLEEDING AND VAGINAL WALL LACERATIONS IS THE DISSECTION IN THE PROPER PLANE AND AWAY FROM THE ANTERIOR VAGINAL WALL. ACCORDING TO THE AUTHORS, THE CAUSE OF THE VOIDING DIFFICULTY IS USUALLY OVERCORRECTION WITH TIGHT TAPE. IN THIS STUDY, THE MANUALLY DESIGNED TRANSOBTURATOR POLYPROPYLENE MESH SLING IS AN EASY, CHEAP, AND COST-EFFECTIVE METHOD FOR THE TREATMENT OF FEMALE SUI WITH HIGH SUCCESS RATE AND FEW SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435034 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention