BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7847572 · Received September 5, 2018

    Report

    Report Number
    2210968-2018-75631
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J. 2015; 26: 1815 1820. DOI: 10.1007/S00192-015-2772-Z. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RETROSPECTIVE COMPARISON BETWEEN THE PROLIFT AND ELEVATE ANTERIOR VAGINAL MESH PROCEDURES: 18-MONTH CLINICAL OUTCOME". AUTHORS: ARTUR ROGOWSKI, PRZEMYSLAW BIENKOWSKI, DARIUSZ TARWACKI, MONIKA SZAFAROWSKA, JERZY SAMOCHOWIEC, HALINA SIENKIEWICZ-JAROSZ, MALGORZATA JERZAK, WLODZIMIERZ BARANOWSKI. CITATION: INT UROGYNECOL J. 2015; 26: 1815 1820. DOI: 10.1007/S00192-015-2772-Z. THERE ARE FEW DIRECT COMPARISONS BETWEEN THE FIRST-GENERATION TROCAR-GUIDED AND THE SECOND GENERATION SINGLE-INCISION MESH SYSTEMS IN THE TREATMENT OF ANTERIOR PELVIC ORGAN PROLAPSE (POP). THE PURPOSE OF THIS RETROSPECTIVE REVIEW WAS TO COMPARE 18-MONTH OPERATIVE SUCCESS IN FEMALE PATIENTS WHO HAD UNDERGONE POP SURGERY WITH THE IMPLANTATION OF THE GYNECARE PROLIFT ANTERIOR MESH (ETHICON; N-52; AGE: 68.5 ± 7.9 YEARS; BMI: 27.3 ± 3.0) OR THE ANTERIOR ELEVATE MESH (N-62; AGE: 66.1 ± 7.4; BMI: 28.3 ± 3.3). IN THE PROLIFT GROUP, REPORTED COMPLICATIONS INCLUDED VAGINAL EXPOSURE (N-4), DE NOVO STRESS URINARY INCONTINENCE (N-6), DE NOVO OVERACTIVE BLADDER (N-1), POST-OPERATIVE PELVIC FLOOR PAIN (N-6), AND POST-OPERATIVE DYSPAREUNIA (N-6). THE AUTHORS FOUND A SIGNIFICANTLY HIGHER RISK OF VAGINAL EXPOSURE AFTER THE PROLIFT MESH IMPLANTATION. THIS MAY BE DUE TO A LARGER SIZE OF THE PROLIFT MESH RESULTING IN INSUFFICIENT INTRAOPERATIVE MESH SPREADING OR MESH FOLDING SOON AFTER SURGERY. THE RESULTS SHOWED THAT THE USE OF THE ELEVATE SYSTEM IN PATIENTS WITH ANTERIOR COMPARTMENT PROLAPSE RESULTS IN FEWER MESH EROSIONS, BUT SIMILAR EFFICACY, COMPARED WITH THE PROLIFT MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690115 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention