BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 9274433 · Received November 4, 2019

    Report

    Report Number
    2210968-2019-89451
    Event Type
    Injury
    Date Received
    November 4, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: ANN PLAST SURG 2019;82: S332¿S338; DOI: 10.1097/SAP.0000000000001768. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: HEALTH-RELATED QUALITY OF LIFE AFTER VENTRAL HERNIA REPAIR WITH BIOLOGIC AND SYNTHETIC MESH. THIS STUDY AIMED TO ASSESS QUALITY OF LIFE (QOL) IN PATIENTS WHO HAD UNDERGONE VHR AT (B)(6) MEDICAL CENTER. BETWEEN 1998 AND 2017, A TOTAL OF 175 PATIENTS (N=89 FEMALES N=86 MALES, MEAN AGE OF 54 YEARS, RANGE 22¿81 YEARS) WERE INCLUDED IN THE STUDY. OF THESE PATIENTS, 91 HAD UNDERGONE SYNTHETIC MESH REPAIR (SMR), 23 HAD BIOLOGIC MESH REPAIR (BMR) AND SUTURE REPAIR (SR) HAD BEEN PERFORMED IN 60 PATIENTS. SYNTHETIC MESH TYPES INCLUDED PROLENE (ETHICON) (N = 46), PHYSIOMESH (ETHICON) (N=3), COMBINED PROLENE AND PARIETEX (N=3), COMBINED PHYSIOMESH AND PROGRIP (N=1), PROCEED (ETHICON) (N=1), AND COMBINED PROCEED AND PROLENE (N=1). COMPLAINTS FOR PROLENE MESH INCLUDED HEMATOMA (N=5), SEROMA (N=3), INFECTION (N=3), RECURRENCE (N=3), AND ANY COMPLICATIONS (N=9). COMPLAINTS FOR OTHER SMR GROUP INCLUDES HEMATOMA, SEROMA, INFECTION, RECURRENCE, AND ANY COMPLICATIONS (PHYSIOMESH N=?, COMBINED PROLENE AND PARIETEX N=?, COMBINED PHYSIOMESH AND PROGRIP N=?, PROCEED N=?, AND COMBINED PROCEED AND PROLENE N=?). THE DATA IN THIS STUDY INDICATE THAT QOL IS COMPARABLE BETWEEN PATIENTS WITH SMR AND SR; HOWEVER, IT IS LOWER IN PATIENTS WITH MVHWG GRADE 2 HERNIAS AND BMR COMPARED WITH SMR AND SR. MOREOVER, OUR DATA SHOW THAT CS DOES NOT IMPACT POSTOPERATIVE QOL REGARDLESS OF THE TYPE OF MESH BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069673 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention