BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8920963 · Received August 22, 2019

    Report

    Report Number
    2210968-2019-85982
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: SAUDI MED J (2010); 31(2): 180-184. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: MESH EROSION AFTER PELVIC RECONSTRUCTIVE SURGERIES. THE AIM OF THE STUDY IS TO REPORT AN EXPERIENCE ON THE EROSION OF POLYPROPYLENE MESH USED IN PELVIC RECONSTRUCTIVE SURGERIES, AND TO DISCUSS THE PATHOLOGICAL CHANGES OF MESH EROSION. THIS RETROSPECTIVE STUDY INVOLVES 128 FEMALE PATIENTS (AGE RANGE: 30-83 YEARS) WHO RECEIVED PELVIC RECONSTRUCTIVE SURGERIES WITH POLYPROPYLENE MESH FROM MAY 2006 TO MAY 2009. IN THE ANTEROPOSTERIOR COLPORRHAPHY, THE VAGINA WAS DISSECTED CAREFULLY, AND THE BLADDER WAS SEPARATED FROM THE VAGINA. THE PARAVESICAL FOSSA WAS OPENED ON BOTH SIDES, AND THE MESH WAS THEN INTRODUCED TENSION-FREE. THE MESH WAS CUT TO A PROPER SIZE (6 CM IN WIDTH X 15 CM IN LENGTH), AND PREPARED UNDER STRICT ASEPTIC CONDITIONS. IN THE LAPAROSCOPIC SACRAL SUSPENSION, THE MESH WAS SECURED IN THE RECTOVAGINAL SEPTUM AND VESICOVAGINAL SEPTUM, AND SUTURED PERIOSTEUM ABOVE THE FIRST SACRAL VERTEBRA WITH AT LEAST 3 PERMANENT SUTURES. PROLENE POLYPROPYLENE MESH (ETHICON) WAS USED IN ALL 128 PATIENTS. REPORTED COMPLICATIONS INCLUDED: A MULTINUCLEATED GIANT CELL AND FOREIGN-BODY GRANULOMA WAS DETECTED IN THE ERODED TISSUE (N-1). IN CONCLUSION, MOST POLYPROPYLENE MESH EROSIONS OCCUR WITHIN ONE YEAR POSTOPERATIVELY. REMOVAL OF THE MESH COULD BE THE BEST THERAPY FOR MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716248 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention