BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH UNKNOWN PRODUCT

    MDR report key: 8928603 · Received August 23, 2019

    Report

    Report Number
    2210968-2019-86082
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    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: BRITISH JOURNAL OF SURGERY 2006; 93: 1056¿1059 / DOI: 10.1002/BJS.5403. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: THREE-YEAR RESULTS OF A RANDOMIZED CLINICAL TRIAL OF LIGHTWEIGHT OR STANDARD POLYPROPYLENE MESH IN LICHTENSTEIN REPAIR OF PRIMARY INGUINAL HERNIA. THE PURPOSE OF THIS RANDOMIZED CLINICAL TRIAL WAS TO COMPARE THE BENEFITS OF LIGHTWEIGHT (LW) POLYPROPYLENE MESH (LARGE PORE SIZE, PARTIALLY ABSORBABLE) AND STANDARD POLYPROPYLENE MESH IN REDUCING CHRONIC PAIN AND INFLAMMATION AFTER INGUINAL HERNIA REPAIR. FROM DEC 2000 TO APR 2002, A TOTAL OF 494 MALE PATIENTS (OVER 25 YEARS OF AGE) WITH A UNILATERAL PRIMARY INGUINAL HERNIA WERE ELIGIBLE TO PARTICIPATE IN THE STUDY. THE PATIENTS WERE RANDOMIZED TO LICHTENSTEIN REPAIR USING A STANDARD POLYPROPYLENE MESH (PROLENE MESH) OR A LW MESH (VYPRO II). A 7.5 X 15CM PROLENE MESH (ETHICON) OR A VYPRO II MESH (ETHICON) WAS USED ACCORDING TO THE RANDOMIZATION. POSTOPERATIVE COMPLICATIONS INCLUDED RECURRENCE (N=18, N=9 IN PROLENE, N=9 IN VYPRO II); TESTICULAR ATROPHY (N=7, N=3 IN PROLENE, N=4 IN VYPRO II); NEURALGIA (N=15, N=9 IN PROLENE, N=6 IN VYPRO II); PAIN ON PALPATION (N=10, N=8 IN PROLENE, N=2 IN VYPRO II); HYPOAESTHESIA OR HYPERAESTHESIA (N=34, N=19 IN PROLENE, N=15 IN VYPRO II); PAIN IN THE GROIN (N=118, N=66 IN PROLENE, N=52 IN VYPRO II); FEELING THE MESH IN THE GROIN (N=92, N=55 IN PROLENE, N=37 IN VYPRO II); AND DISCOMFORT IN THE GROIN (N=77, N=40 IN PROLENE, N=33 IN VYPRO II). USE OF LW MESH FOR LICHTENSTEIN HERNIA REPAIR DID NOT AFFECT RECURRENCE RATES, BUT IMPROVED SOME ASPECTS OF PAIN AND DISCOMFORT 3 YEARS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718000 VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention