BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8913388 · Received August 20, 2019

    Report

    Report Number
    2210968-2019-85873
    Event Type
    Injury
    Date Received
    August 20, 2019
    Report Date
    July 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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: HERNIA (2002) 6: 51¿55 / DOI 10.1007/S10029-002-0054-4. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: THE USE OF THREE DIFFERENT MESH MATERIALS IN THE TREATMENT OF ABDOMINAL WALL DEFECTS. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE FINAL OUTCOME IN TREATING ABDOMINAL WALL DEFECTS WITH THREE DIFFERENT PROSTHETIC MATERIALS. BETWEEN 1996 AND 2000, A TOTAL OF 56 PATIENTS UNDERWENT SURGERY FOR THE TREATMENT OF LARGE ABDOMINAL WALL DEFECTS WITH THE USE OF SYNTHETIC PROSTHETIC MATERIALS. THE PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO THE PROSTHETIC MATERIAL USED IN THE MESH FOR RECONSTRUCTING THE ABDOMINAL WALL DEFECT: PP GROUP, UTILIZED DOUBLE-FIBER POLYPROPYLENE (PROLENE MESH) (N=24, N=9 MALE, N=15 FEMALE, MEAN AGE 57.4 ± 10 YEARS); E-PTFE GROUP, USED EXPANDED POLYTETRAFLUOROETHYLENE (DUALMESH) (N=23, N=9 MALE, N=14 FEMALE, MEAN AGE 55 ± 17 YEARS); AND HCPE GROUP, UTILIZED HYDROPHILIC AND RESORBABLE MEMBRANE COATED POLYESTER (PARIETEX COMPOSITE MESH) (N=9, N=2 MALE, N=7 FEMALE, MEAN AGE 56 ± 13 YEARS). IN PP GROUP, PROLENE MESH WAS APPLIED PREPERITONEALLY AFTER BLUNT MOBILIZATION OF THE PERITONEUM IN A DISTANCE OF 4¿5 CM FROM THE DEFECT EDGE. POSTOPERATIVE COMPLICATIONS INCLUDED INFECTION (N=2) WHEREIN ONE LED TO THE REMOVAL OF THE MESH IN ONE OBESE WOMAN 19 DAYS AFTER THE INITIAL OPERATION; FISTULA (N=1) WHICH WAS TREATED WITH MESH REMOVAL 3 MONTHS AFTER THE INITIAL OPERATION; RECURRENCE (N=2) WHEREIN ONE OF THEM WAS TREATED WITH THE USE OF E-PTFE MESH 8 MONTHS LATER; AND FEELING OF FIRM ABDOMINAL SENSATION AND DISCOMFORT (N=4). THE USE OF PROSTHETIC MATERIAL HAS SIGNIFICANTLY CONTRIBUTED TO LOWERING OF THE RECURRENCE RATE, DESPITE THE FEW COMPLICATIONS. PP MESH IS CHEAP BUT NOT SUITABLE FOR INTRAPERITONEAL APPLICATION. E-PTFE MESH HAS A LOW REJECTION RATE AND IS RESISTANT TO INFECTIONS, ESPECIALLY IF IT IS TREATED WITH ANTIMICROBIAL AGENTS. ALTHOUGH EXPENSIVE, IT IS STRONG AND PLIANT AND CAUSES NO ANNOYANCE TO THE PATIENT. WE BELIEVE THAT THIS MESH IS SUITABLE FOR INTRAPERITONEAL USE. HCPE MESH, COMBINING THE ADVANTAGES OF THE ABOVE MATERIALS, IS STRONG, STEADY, AND CHEAPER. WE BELIEVE THAT THIS MATERIAL IS THE MOST SUITABLE FOR THE TREATMENT OF LARGE ABDOMINAL WALL DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703272 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention