BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8040132 · Received November 5, 2018

    Report

    Report Number
    2210968-2018-76954
    Event Type
    Injury
    Date Received
    November 5, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: HERNIA (2017) 21:887¿894; DOI: HTTPS://DOI.ORG/10.1007/S10029-017-1657-0 PLEASE SEE REFERENCED ARTICLE ATTACHED. (B)(4).

    Description of Event or Problem · 1

    TITLE: BILATERAL ENDOSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR DOES NOT IMPAIR MALE FERTILITY THE AIM OF THIS OBSERVATIONAL PROSPECTIVE COHORT STUDY WAS TO ASSESS FERTILITY AFTER BILATERAL ENDOSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR IN MALE PATIENTS. BETWEEN MAR2010 AND MAR2016, 57 MALE PATIENTS (AGE OF 51.0 YEARS [42.0¿56.2 YEARS]) WITH PRIMARY BILATERAL HERNIA UNDERWENT ENDOSCOPIC TEP HERNIA REPAIR. IN THE PROCEDURE, TWO IDENTICAL PROLENE MESH, MEASURING 10X15 CM, WERE POSITIONED IN A TENSION-FREE MANNER IN THE PREPERITONEAL SPACE. POSTOPERATIVE COMPLICATIONS INCLUDED HEMATOMA (N=4) IN WHICH 2 PATIENTS WERE ASSOCIATED WITH PAIN SUBSIDED WITH CONSERVATIVE TREATMENT, AND RECURRENCE (N=4) IN WHICH TWO UNDERWENT ADDITIONAL OPERATION. THE PRESENT STUDY SHOWS NO IMPAIRMENT OF FERTILITY 6 MONTHS AFTER BILATERAL ENDOSCOPIC TEP INGUINAL HERNIA REPAIR. POLYPROPYLENE, THE BIOMATERIAL MOST COMMONLY USED IN MESH HERNIA REPAIR, HAS GOOD MECHANICAL STABILITY AND INDUCES AN ACUTE INFLAMMATORY REACTION FOLLOWED BY A CHRONIC FOREIGN BODY FIBROBLASTIC REACTION, WHICH IS ESSENTIAL FOR OPTIMAL FIXATION AND INCORPORATION OF THE BIOMATERIAL IN THE ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876973 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention