BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7673869 · Received July 10, 2018

    Report

    Report Number
    2210968-2018-74208
    Event Type
    Injury
    Date Received
    July 10, 2018
    Report Date
    June 13, 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). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 PRODUCTS 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 PRODUCTS INVOLVED? CITATION: THE LANCET VOLUME 391, NO. 10123, P860¿869, 3 2018; DOI: HTTP://DX.DOI.ORG/10.1016/S0140-6736(18)30298-8. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MESH VERSUS SUTURE REPAIR OF UMBILICAL HERNIA IN ADULTS: A RANDOMISED, DOUBLE-BLIND, CONTROLLED, MULTICENTRE TRIAL" AUTHOR(S): RUTH KAUFMANN, JENS A HALM, HASAN H EKER, PIETER J KLITSIE, JEROEN NIEUWENHUIZEN, DICK VAN GELDERE, MAARTEN P SIMONS, ERWIN VAN DER HARST, MARTIJNE VAN ¿T RIET, BRONNO VAN DER HOLT, GERT JAN KLEINRENSINK, JOHANNES JEEKEL, JOHAN F LANGE CITATION: THE LANCET VOLUME 391, NO. 10123, P860¿869, 3 2018; DOI: HTTP://DX.DOI.ORG/10.1016/S0140-6736(18)30298-8. THIS RANDOMIZED, DOUBLE-BLIND, CONTROLLED, MULTI-CENTRE TRIAL AIMED TO INVESTIGATE WHETHER USE OF A MESH WAS BETTER IN REDUCING RECURRENCE COMPARED WITH SUTURE REPAIR FOR SMALLER UMBILICAL HERNIAS. BETWEEN 21JUN2006 AND 16APR2014, 300 PATIENTS WITH UMBILICAL HERNIA FROM 12 HOSPITALS WERE RANDOMLY ASSIGNED TO MESH REPAIR (N=150) AND SUTURE REPAIR (N=150). AFTER A MAXIMUM FOLLOW-UP OF 30 MONTHS, 284 PATIENTS WERE INCLUDED FOR ANALYSIS FOR SUTURE REPAIR (N=138; N=113 MALE AND N=25 FEMALE; MEDIAN AGE OF 52 YEARS) AND MESH REPAIR (N=146; N=122 MALE AND N=24 FEMALE; MEDIAN AGE OF 5 YEARS). IN SUTURE REPAIR, UMBILICAL DEFECT REPAIR WAS CONSISTED OF ADAPTATION OF THE FASCIA IN THE MIDLINE BY EITHER INTERRUPTED OR CONTINUOUS MONOFILAMENT 0/0 PROLENE SUTURE FOR WHICH SUTURES WERE PLACED IN A TRANSVERSE DIRECTION. IN MESH REPAIR, BARD MESH OR PROLENE MESH WERE PLACED IN THE PLANE PREPERITONEAL PLANE WHICH WAS FIXED USING 0/0 PROLENE SUTURES. POSTOPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION (N=1 SUTURE REPAIR AND N=3 MESH REPAIR), HAEMATOMA (N=2 SUTURE REPAIR AND N=3 MESH REPAIR) AND SEROMA (N=1 SUTURE REPAIR AND N=5 MESH REPAIR). ONE PATIENT FROM MESH REPAIR WHO HAD SEROMA UNDERWENT SEROMA EVACUATION. AFTER A MAXIMUM FOLLOW-UP OF 30 MONTHS, RECURRENCE WAS OBSERVED IN SUTURE GROUP (N=17) AND MESH GROUP (N=6). THERE WERE NO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF POSTOPERATIVE WOUND INFECTIONS, ALTHOUGH THE INCIDENCE IN THE MESH GROUP WAS SLIGHTLY HIGHER IN THE MESH GROUP VERSUS THE SUTURE GROUP. NO MESH HAD TO BE SURGICALLY REMOVED BECAUSE OF INFECTION. THE AUTHORS ADVOCATE THE USED OF MESH REPAIR IN ALL PATIENTS WITH AN UMBILICAL HERNIA WITH A DIAMETER OF AT LEAST 1 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516772 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention