BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7479261 · Received May 2, 2018

    Report

    Report Number
    2210968-2018-72510
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. CITATION: AM J OBSTET GYNECOL. 2011; 204 (74). E1 8. DOI: 10.1016/J.AJOG.2010.08.036. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE:TROCAR-GUIDED MESH REPAIR OF VAGINAL PROLAPSE USING PARTIALLY ABSORBABLE MESH: 1 YEAR OUTCOMES" AUTHOR : ALFREDO L. MILANI, MD; PIET HINOUL, MD; JUDI M. GAULD, BSC; VANJA SIKIRICA, PHARMD, MPH; DOUGLAS VAN DRIE, MD; MICHEL COSSON, MD, PHD CITATION: AM J OBSTET GYNECOL. 2011; 204 (74). E1 8. DOI: 10.1016/J.AJOG.2010.08.036 THE OBJECTIVE OF THIS PROSPECTIVE MULTI-CENTER COHORT STUDY WAS TO EVALUATE THE ANATOMIC AND FUNCTIONAL OUTCOMES AT 1-YEAR FOLLOWING TROCAR-GUIDED TRANSVAGINAL PROLAPSE REPAIR USING A PARTIALLY ABSORBABLE MESH. A TOTAL OF 127 PATIENTS WITH PELVIC ORGAN PROLAPSE STAGE III HAD SURGERY AND WERE EVALUATED AT 3 MONTHS AND 1-YEAR POST-SURGERY COMPARED WITH BASELINE. ALL PATIENTS UNDERWENT THE STANDARDIZED TRANSVAGINAL MESH PLACEMENT TECHNIQUE OF PROLIFT+M MESH. DEPENDING ON THE SITE OF PROLAPSE, THE MESH REPAIR COULD BE ANTERIOR, POSTERIOR, OR TOTAL; IN PATIENTS WITH AN INTACT UTERUS, THE TOTAL MESH WAS MADE. REPORTED COMPLICATIONS INCLUDED RECURRENCE OF PROLAPSE (N-1) WHICH REQUIRED RE-OPERATION WITH NEW PROLIFT+M MESH PLACEMENT, UTERO-VAGINAL PROLAPSE (N-1) WHICH REQUIRED VAGINAL HYSTERECTOMY, POSTERIOR VAGINAL WALL PROLAPSE (N-1) WHICH REQUIRED SUBSEQUENT LAPAROSCOPIC SACROCOLPOPEXY, APICAL FAILURE (N-1) WHICH REQUIRED SUBSEQUENT LAPAROSCOPIC SACROCOLPOPEXY, WOUND INFECTION (N-2), INFECTED HEMATOMA (N-1), AND MESH EXPOSURE (N-13) IN WHICH PARTIAL MESH EXCISION WAS REQUIRED IN 7 PATIENTS AND TREATMENT WITH TOPICAL ESTROGEN WAS MADE IN 6 PATIENTS. IT WAS CONCLUDED THAT THE RESULTS OF THIS STUDY ARE SUGGESTIVE THAT THIS LIGHTWEIGHT MESH PROVIDES ANATOMIC SUPPORT CONSISTENT WITH THE ORIGINAL POLYPROPYLENE MESH AND DEMONSTRATE HIGH FUNCTIONAL IMPROVEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321548 PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention