BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7481415 · Received May 2, 2018

    Report

    Report Number
    2210968-2018-72556
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (2011) 22 (SUPPL 1):S79-80. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: ONE YEAR OUTCOMES AND THE QUALITY OF LIFE OF ELDERLY WOMEN WITH PELVIC ORGAN PROLAPSE AFTER TENSION-FREE VAGINAL MESH (TVM) REPAIR¿. AUTHOR: KATO K., SUZUKI S., YAMAMOTO S., FURUHASHI K., SUZUKI K., MURASE T., GOTOH M. WEB ADDRESS: HTTP://DOI.ORG/10.1007/S00192-011-1434-Z. CITATION: INT UROGYNECOL J (2011) 22 (SUPPL 1):S79-80. THE AIM OF THIS STUDY WAS TO ASSESS THE IMPACT OF AGE ON CLINICAL OUTCOMES AND THE QUALITY OF LIFE (QOL) OF THE PATIENTS WHO UNDERWENT TENSION-FREE VAGINAL MESH (TVM) REPAIR TO TREAT PELVIC ORGAN PROLAPSE (POP). BETWEEN 2006 AND 2008, 505 FEMALE PATIENTS WITH POP QUANTIFICATION (POP-Q) STAGE III OR IV UNDERWENT TVM REPAIR AND WERE STRATIFIED INTO THREE GROUPS ACCORDING TO AGE GROUP: YOUNG (=64 YEARS; N=197), YOUNG-OLD (65-74 YEARS; N=213), AND OLD-OLD (=75 YEARS; N=95). TVM REPAIR WAS PERFORMED BY CUTTING GYNEMESH PS INTO A SIMILAR SHAPE AS PROLIFT¿ AND INSERTING THEIR ARMS THROUGH THE OBTURATOR FORAMEN AND SACROSPINOUS LIGAMENT. WITHIN 1-YEAR FOLLOW-UP, 8 PATIENTS HAD VAGINAL MESH EXPOSURE. PROLAPSE RECURRENCE WAS ALSO OBSERVE IN YOUNG GROUP (N=74), YOUNG OLD GROUP (N=57) AND OLD-OLD GROUP (N=17) WHERE MOST WERE ASYMPTOMATIC POINT AA FAILURE AND ONLY 5 CASES NEEDED REINTERVENTION. COMPLICATIONS AND OUTCOMES OF TVM REPAIR DID NOT DIFFER SIGNIFICANTLY BETWEEN AGE GROUPS. TVM REPAIR MARKEDLY IMPROVED QOL, PROLAPSE SYMPTOMS, OAB SYMPTOMS, AND VOIDING SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324410 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention