BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8387886 · Received March 4, 2019

    Report

    Report Number
    2210968-2019-79240
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    February 28, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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: THE AMERICAN JOURNAL OF SURGERY (2011) 202, 188¿193; DOI:10.1016/J.AMJSURG.2010.06.027.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL COMPARING THE PROLENE HERNIA SYSTEM® AND THE LICHTENSTEIN PATCH TECHNIQUE FOR INGUINAL HERNIA REPAIR IN LONG TERM: 2- AND 5-YEAR RESULTS. THIS PROSPECTIVE STUDY WAS DESIGNED TO COMPARE THE CONVALESCENCE AND THE LONG-TERM SEQUELAE IN INGUINAL HERNIA REPAIR WITH EITHER A BILAYER MESH AS DEVISED BY GILBERT ET AL OR AN ONLAY MESH APPLIED ACCORDING TO LICHTENSTEIN. BETWEEN SEP2001 AND JAN2004, 300 ADULT PATIENTS (N=282 MALE AND N=18 FEMALE) UNDERWENT ELECTIVE REPAIR FOR UNILATERAL OR BILATERAL INGUINAL HERNIAS AND WERE DIVIDED INTO TWO GROUPS BASED ON THE REPAIR TECHNIQUE: PROLENE HERNIA SYSTEM (N=150; N=140 MALE AND N=10 FEMALE; MEAN AGE OF 46 YEARS [19-72 YEARS]) AND LICHTENSTEIN (N=150; N=142 MALE AND N=8 FEMALE; MEAN AGE OF 47 YEARS [20-70 YEARS]). IN PROLENE HERNIA SYSTEM, NO FIXING SUTURES WERE USED WHEN APPLYING THE BILAYER MESH (PHS) EXCEPT FOR A NEW LARGE DIRECT HERNIAS, FOR WHICH THE ONLAY PART WAS SECURED MEDIALLY WITH 2 OR 3 POLYGLACTIN ABSORBABLE (VICRYL; ETHICON ENDO-SURGERY, INC) SUTURES (20 PATIENTS, 13% OF THE PATIENTS IN THE PHS GROUP). POSTOPERATIVELY RESULTS AT 5 YEARS IN PHS GROUP INCLUDED PAIN ALTOGETHER (N=12) TREATED WITH PAIN MEDICATION (N=1); MESH PERCEPTIBLE (N=16); SENSORY DYSFUNCTION OF THE SKIN (N=6); AND DISCOMFORT (N=23). THIS STUDY INDICATES THAT THE BILAYER MESH DEVICE PHS GIVES COMPARABLE LONG-TERM RESULTS WITH THE LICHTENSTEIN PROCEDURE IN TERMS OF RECURRENCE RATE AND CHRONIC PAIN IN THE REPAIR OF INGUINAL HERNIA. BESIDES CHRONIC POSTOPERATIVE PAIN, DOWNSIDES OF INGUINAL HERNIA SURGERY SEEM TO INCLUDE SENSORY DYSFUNCTION OF THE SKIN AND DISCOMFORT IN A RELATIVELY HIGH PROPORTION OF PATIENTS, EVEN AFTER >5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181481 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention