BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8953925 · Received September 2, 2019

    Report

    Report Number
    2210968-2019-86468
    Event Type
    Injury
    Date Received
    September 2, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 2007; 11: 125128. DOI: 10.1007/S10029-006-0179-YT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: INGUINAL HERNIA REPAIR: THE CHOICE OF PROSTHESIS OUTWEIGHS THAT OF TECHNIQUE. THE USE OF PROSTHESES IN INGUINAL HERNIA REPAIR REDUCES THE INCIDENCE OF RECURRENCE. THE AIM OF THE STUDY WAS TO EVALUATE THE 2-YEAR INCIDENCE OF RECURRENCE AND PAIN FOR TWO TYPES OF HERNIOPLASTY, LICHTENSTEIN REPAIR AND LAPAROSCOPY (TOTALLY EXTRAPERITONEAL APPROACH OR TEP), AND TWO TYPES OF MESH; POLYPROPYLENE MESH AND BETA-D-GLUCAN-COATED MESH. A TOTAL OF 410 CONSECUTIVE PATIENTS (396 MALE AND 14 FEMALE PATIENTS; AGE RANGE: 18 TO 84 YEARS OLD) UNDERWENT REPAIR OF INGUINAL HERNIAS. A TOTAL OF 273 PATIENTS UNDERWENT LICHTENSTEIN REPAIR; 215 PATIENTS WITH POLYPROPYLENE MESH AND 58 PATIENTS WITH GLUCAMESH. A TOTAL OF 137 PATIENTS UNDERWENT LAPAROSCOPY REPAIR; 80 PATIENTS WITH POLYPROPYLENE MESH AND 57 PATIENTS WITH GLUCAMESH. IN PATIENTS WHO UNDERWENT BOTH THE LICHTENSTEIN AND LAPAROSCOPIC REPAIR WITH THE USE OF POLYPROPYLENE MESH, REPORTED COMPLICATIONS INCLUDED RECURRENCE (N-8), CHRONIC PAIN (N-64), AND SEVERE PAIN (N-10). THERE IS NO CONSENSUS CONCERNING THE REPAIR TECHNIQUE FOR INGUINAL HERNIA. HOWEVER, IT IS CLEAR THAT THE UTILIZATION OF PROSTHETIC STRENGTHENING SIGNIFICANTLY REDUCES THE INCIDENCE OF RECURRENCE. THE FINDINGS SUGGEST THAT AT 2-YEAR FOLLOW-UP, THE QUALITY OF HERNIA REPAIR IN TERMS OF EFFICACY AND QUALITY OF LIFE IS DETERMINED MORE BY THE CHARACTERISTICS OF THE PROSTHESIS THAN BY THE TECHNIQUE UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747174 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention