BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7902522 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75947
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    August 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    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. CITATION: INT UROGYNECOL J. 2015; 26 (1): S23¿S174.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : LONG-TERM OUTCOME AFTER TRANSVAGINAL MESH REPAIR OF PELVIC ORGAN PROLAPSE. " AUTHOR: P. HEINONEN, R. AALTONEN, K. JORONEN, S. ALANISSILÄ CITATION: INT UROGYNECOL J. 2015; 26 (1): S23¿S174. THE AUTHORS EVALUATED THE SUBJECTIVE AND OBJECTIVE OUTCOME OF THE TRANSVAGINAL MESH (TVM) PROCEDURE AFTER A MEDIAN OF 7 YEARS FOLLOW-UP. THE LONG-TERM COMPLICATIONS, REOPERATIONS AND PATIENT SATISFACTION WERE OF PARTICULAR INTEREST. THIS STUDY CONSISTS OF TVM PROCEDURES PERFORMED IN 161 PATIENTS (MEAN AGE: 71 YEARS; MEAN BMI: 27 KG/M2) BETWEEN MAY 2007 AND MARCH 2009 BY USING PROLIFT TRANSVAGINAL MESH COMMERCIAL KIT (ETHICON). INDICATIONS FOR USING MESH WERE RECURRENT POP OR LARGE PRIMARY POP WITH A PARAVAGINAL DEFECT AND/OR APICAL PROLAPSE. REPORTED COMPLICATIONS INCLUDED ABNORMAL PALPATION OF THE MESH (N-12), MESH EXPOSURE (N-36) WHICH REQUIRED MESH RESECTION (N-18), EXPOSURE THROUGH VAGINAL EPITHELIUM (N-32), EXPOSURE THROUGH BOWEL (N-1), MESH EROSION (N-49), DYSPAREUNIA (N-2), POP IN ANY COMPARTMENT (16.2%) WHICH REQUIRED RE-OPERATION, AND POP IN THE TREATED COMPARTMENT (5%) WHICH REQUIRED RE-OPERATION. IT WAS REPORTED THAT THE LONG-TERM SUBJECTIVE OUTCOME IS SATISFACTORY AND PATIENT SATISFACTION WAS HIGH AFTER THE TVM PROCEDURE. MESH EXPOSURE RATE WAS HIGH; MOST OF THE EXPOSURES WERE LATE ONSET AND ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744555 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention