BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7484539 · Received May 3, 2018

    Report

    Report Number
    2210968-2018-72572
    Event Type
    Injury
    Date Received
    May 3, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? NO. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? YES. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? APART FROM DESIGN, NO. CITATION: INT UROGYNECOL J (2015) 26:71¿77; DOI 10.1007/S00192-014-2467-X. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: OUTCOMES OF TROCAR-GUIDED GYNEMESH PS¿ VERSUS SINGLE-INCISION TROCARLESS POLYFORM¿ TRANSVAGINAL MESH PROCEDURES¿ AUTHOR(S): MARYSE LAROUCHE & LISA MEROVITZ & JOSÉ A. CORREA & JENS-ERIK WALTER CITATION: INT UROGYNECOL J (2015) 26:71¿77; DOI 10.1007/S00192-014-2467-X. THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO COMPARE RATES OF SUCCESS, MESH EXPOSURE, AND SURGICAL REINTERVENTION AFTER TROCAR-GUIDED GYNEMESH PS AND TROCARLESS POLYFORM TRANSVAGINAL MESH PROCEDURES. BETWEEN JAN2008 AND MAY2012, 103 FEMALE PATIENTS WHO UNDERWENT TRANSVAGINAL MESH PROCEDURES WERE INCLUDED AND ASSIGNED INTO TWO GROUPS: TROCAR-GUIDED GYNEMESH PS TRANSVAGINAL SYSTEM (N=47; MEAN AGE SD OF 69.3±7.8 YEARS) AND TROCARLESS POLYFORM (N=56; MEAN AGE SD OF 69.7±8.2 YEARS). DURING THE FOLLOW-UP, 9 PATIENTS IN TROCAR GROUP HAD TRUE RECURRENCE OF PROLAPSE STAGE II OR MORE IN THE MESH COMPARTMENT FOR WHICH 3 OF THEM WERE TREATED WITH TRADITIONAL COLPORRHAPHY. IN THE TROCAR GROUP, 11 PATIENTS HAD MESH EXPOSURES WHERE 4 PATIENTS WERE TREATED CONSERVATIVELY WITH ESTROGEN CREAM APPLICATION AND 7 PATIENTS TREATED SURGICALLY. ALSO, ONE PATIENT IN THE TROCAR-GUIDED GROUP HAD PELVIC PAIN ASSOCIATED WITH MESH EXPOSURE WHICH WAS TREATED SURGICALLY. THE AUTHORS STATED THAT THE REASON BEHIND RECURRENCE IN THE SAME COMPARTMENT MAY BE RELATED TO MESH ARM RELEASE FROM LIGAMENTOUS SUPPORT. TROCAR-GUIDED GYNEMESH PS AND TROCARLESS POLYFORM TRANSVAGINAL MESH SYSTEMS RESULT IN SIMILAR OBJECTIVE AND SUBJECTIVE SUCCESS RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327381 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention