BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8927458 · Received August 23, 2019

    Report

    Report Number
    2210968-2019-86079
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 (2005) 9: 223¿227; DOI 10.1007/S10029-005-0324-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ONE YEAR RESULTS OF A RANDOMISED CONTROLLED MULTI-CENTRE STUDY COMPARING PROLENE AND VYPRO II-MESH IN LICHTENSTEIN HERNIOPLASTY. THIS INTERNET-BASED STUDY WAS DESIGNED TO COMPARE A STANDARD POLYPROPYLENE MESH WITH THE NEW POLYPROPYLENE/POLYGLACTIN MESH IN THE LICHTENSTEIN OPERATION. FROM DEC2000 TO APR2002, 591 MALE PATIENTS WITH UNILATERAL PRIMARY INGUINAL HERNIA WERE RANDOMIZED TO LICHTENSTEIN OPERATION USING PROLENE MESH (N=295; MEAN AGE SD OF 54 YEARS [14 YEARS]) OR VYPRO MESH (N=296; MEAN AGE SD OF 55 YEARS [14 YEARS]). IN THE PROCEDURE, A PIECE OF 7.5X15 CM (PROLENE, ETHICON (B)(4) OR VYPRO II, ETHICON (B)(4)) MESH WAS USED ACCORDING TO THE ASSIGNMENT. AT 1-YEAR FOLLOW-UP, COMPLICATIONS INCLUDED BULGE IN THE GROIN (N=16 PROLENE GROUP), GROIN PAIN (N=32 PROLENE GROUP), NEURALGIA (N=3 PROLENE GROUP) IN WHICH ONE PATIENT WAS RE-OPERATED WITH NEUROTOMI AFTER 10 WEEKS AND WAS COMPLETELY RECOVERED. IN PROLENE GROUP, RECURRENCE (N=4) WERE TREATED WITH REOPERATION USING PLUG (N=1), TEP (N=2), AND MESH-PLUG (N=1). IN VYPRO II GROUP, RECURRENCES (N=4) WERE TREATED WITH REOPERATION USING MARCY HERNIOPLASTY + MESH (N=1), LICHTENSTEIN (N=1), TEP (N=1) AND MESH PLUG (N=1). IN LICHTENSTEIN¿S OPERATION THERE IS A POSSIBLE RISK OF INJURING OR CATCHING THE SENSORY NERVES (ILEOINGUINAL, GENITAL BRANCH OF GENITOFEMORAL, ILEOHYPOGASTRIC) WHEN SUTURING THE MESH OR DURING THE FIBROBLASTIC IN-GROWTH POST-OPERATIVELY. THE RESULTS OF LICHTENSTEIN¿S OPERATION WITH EITHER PROLENE OR VYPRO II RESULTED IN LOW INCIDENCE OF HERNIA RECURRENCE AND NEURALGIA IN BOTH GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718452 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention