BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8898868 · Received August 15, 2019

    Report

    Report Number
    2210968-2019-85643
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HONG KONG MED J (2011);17(1):54-60. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: LAPAROSCOPIC SACROCOLPOPEXY FOR THE TREATMENT OF VAGINAL VAULT PROLAPSE: WITH OR WITHOUT ROBOTIC ASSISTANCE. THE AIM OF THIS STUDY IS TO ASSESS PERIOPERATIVE AND MEDIUM-TERM OUTCOME AFTER LAPAROSCOPIC SACROCOLPOPEXY WITH OR WITHOUT ROBOTIC ASSISTANCE FOR VAGINAL VAULT PROLAPSE IN A HONG KONG TERTIARY CENTRE. THIS RETROSPECTIVE STUDY INVOLVES 36 FEMALE PATIENTS (66.8±8.2 YEARS) WHO UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY FOR VAGINAL VAULT PROLAPSE FROM MARCH 2005 TO MAY 2010. FROM 2005 TO 2007, 20 FEMALE PATIENTS UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY (LS) AND FROM MID 2007, 16 PATIENTS UNDERWENT THE ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY (RALS). A Y-SHAPE POLYPROPYLENE MESH (ETHICON) WAS PREPARED AND WAS INTRODUCED, WITH THE TWO DISTAL ARMS ANCHORED TO THE ANTERIOR AND POSTERIOR VAGINAL WALL RESPECTIVELY, USING 2 TO 3 STITCHES ON EACH SIDE. THE PROXIMAL ARM WAS ANCHORED TO THE LONGITUDINAL SACRAL LIGAMENT USING INTERRUPTED ABSORBABLE SUTURES, EXCEPT THAT TITANIUM HELICAL TACKS WERE USED IN TWO PATIENTS. IN LS, FOUR PORTS WERE USED WHILE A TOTAL OF FOUR OR FIVE PORTS WERE INTRODUCED IN RALS. REPORTED COMPLICATIONS IN LS GROUP INCLUDED BLADDER INJURY RELATED TO SACROCOLPOPEXY (N-?) WHICH WAS REPAIRED, DE-NOVO STRESS INCONTINENCE (N-?), DE-NOVO URINARY URGENCY (N-?), DE-NOVO URGE INCONTINENCE (N-?), RECURRENCE OF STAGE II PROLAPSE (N-3), RECURRENCE OF STAGE III PROLAPSE (N-1). IN RALS GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER INJURY RELATED TO SACROCOLPOPEXY (N-?) WHICH WAS REPAIRED, DE-NOVO STRESS INCONTINENCE (N-?), DE-NOVO URINARY URGENCY (N-?), DE-NOVO URGE INCONTINENCE (N-?), RECURRENCE OF STAGE II PROLAPSE (N-2). ONE PATIENT WITH RECURRENCE OF STAGE II PROLAPSE IN EACH LS AND RALS GROUP HAD REOPERATION BY TOTAL VAGINAL MESH REPAIR, AND ANOTHER ONE PREFERRED TO HAVE CONSERVATIVE MANAGEMENT. IN CONCLUSION, LAPAROSCOPIC SACROCOLPOPEXY FOR VAGINAL VAULT PROLAPSE IS SAFE, ALTHOUGH COMPLICATIONS ARISING FROM CONCOMITANT SURGERY SHOULD NOT BE NEGLECTED. LAPAROSCOPIC SACROCOLPOPEXY SHOULD BE CONSIDERED AN OPTION FOR WOMEN WITH VAGINAL VAULT PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690634 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention