BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7495902 · Received May 8, 2018

    Report

    Report Number
    2210968-2018-72660
    Event Type
    Injury
    Date Received
    May 8, 2018
    Report Date
    April 10, 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    TITLE: HIGHER RECURRENCE RATE AFTER ENDOSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR WITH ULTRAPRO LIGHTWEIGHT MESH: 5-YEAR RESULTS OF A RANDOMIZED CONTROLLED TRIAL (TULP-TRIAL). THE AIM OF THE PRESENT STUDY (5-YEAR FOLLOW-UP OF A PREVIOUSLY PERFORMED DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL [TULP-TRIAL]) WAS TO DETERMINE THE RECURRENCE RATE 5 YEARS AFTER ENDOSCOPIC TEP INGUINAL HERNIA REPAIR WHEN EITHER A LIGHTWEIGHT OR HEAVYWEIGHT MESH WAS USED. FROM MARCH 2010 TO OCTOBER 2012, 950 MALE PATIENTS OLDER THAN 18 YEARS OF AGE WITH PRIMARY, REDUCIBLE, UNILATERAL INGUINAL HERNIAS AND NO CONTRAINDICATIONS FOR TEP HERNIA REPAIR WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, FIXATION OF THE MESH WAS NOT ROUTINELY PERFORMED. THE LIGHTWEIGHT MESH WAS A POLYPROPYLENE-POLIGLECAPRONE MONOFILAMENT MESH [ULTRAPRO PARTIALLY ABSORBABLE LIGHTWEIGHT MESH, JOHNSON & JOHNSON COMPANY, AMERSFOORT, THE NETHERLANDS, DIMENSIONS: 10X15 CM, PORE SIZE: 3 TO 4 MM, WEIGHT: 55 G/M2 (28 G/M2 AFTER ABSORPTION OF POLIGLECAPRONE)]. THE HEAVYWEIGHT MESH CONSISTED OF MONOFILAMENT POLYPROPYLENE (PROLENE POLYPROPYLENE MESH, JOHNSON & JOHNSON, DIMENSIONS: 10X15 CM, PORE SIZE: 0.8¿1.2 MM, WEIGHT: 80 G/M2). UP TO 2 YEARS OF FOLLOW-UP, 17 PARTICIPANTS DEVELOPED A RECURRENCE (13 LIGHTWEIGHT, 4 HEAVYWEIGHT). BETWEEN 2 AND 5 YEARS POSTOPERATIVELY, 4 ADDITIONAL RECURRENCES WERE DETECTED IN THE ELECTRONIC PATIENT DOCUMENTATION (3 LIGHTWEIGHT, 1 HEAVYWEIGHT) AFTER 27, 39, 46, AND 55 MONTHS, RESPECTIVELY. THE TOTAL 5-YEAR RECURRENCE RATE OF THE STUDY POPULATION WAS 2.4% (N =23), 18 (3.8%) RECURRENCES OCCURRED IN THE LIGHTWEIGHT MESH GROUP AND 5 (1.1%) IN THE HEAVYWEIGHT MESH GROUP (P =0.01). THE EARLIEST RECURRENCE DEVELOPED 1 MONTH AFTER SURGERY AND THE LAST 2 RECURRENCES WERE DETECTED AT THE 5-YEAR FOLLOW-UP POINT (60 MONTHS). HERNIAS RECURRED AFTER REPAIR OF 13 DIRECT (1 HEAVYWEIGHT, 12 LIGHTWEIGHT) AND 10 INDIRECT HERNIAS (4 HEAVYWEIGHT, 6 LIGHTWEIGHT). OF THE 23 RECURRENCES, 15 WERE REOPERATED (5 HEAVYWEIGHT, 10 LIGHTWEIGHT). AT REOPERATION, 6 DIRECT HERNIAS AND 1 INDIRECT HERNIA WERE FOUND, WHEREAS 3 RECURRENCES WERE NOT FURTHER SPECIFIED. IN 5 CASES ONLY A LIPOMA INSTEAD OF A TRUE HERNIA RECURRENCE WAS FOUND. THREE OF THESE PATIENTS RECEIVED A LIGHTWEIGHT MESH AND 2 RECEIVED A HEAVYWEIGHT MESH. A SIGNIFICANT HIGHER RECURRENCE RATE FOR LIGHTWEIGHT MESH REMAINED WHEN EXCLUDING THE PATIENTS WITH ONLY A LIPOMA FROM ANALYSIS (15 LIGHTWEIGHT VS 3 HEAVYWEIGHT, P =0.004). IN CONCLUSION, THE AUTHORS DEMONSTRATED A LOW RECURRENCE RATE OF 2.4% 5 YEARS AFTER TEP INGUINAL HERNIA REPAIR. THE USE OF LIGHTWEIGHT ULTRAPRO MESH RESULTED IN A RECURRENCE RATE OF 3.8%, WHEREAS ONLY A 1.1% RECURRENCE RATE WAS SEEN AFTER HEAVYWEIGHT MESH IMPLANT. PATIENTS WITH PRIMARY MEDIAL HERNIAS WERE AT GREATEST RISK OF DEVELOPING A RECURRENCE WHEN LIGHTWEIGHT MESH WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338152 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention