BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7935830 · Received October 4, 2018

    Report

    Report Number
    2210968-2018-76327
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    September 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE 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 PRODUCT (TENSION FREE VAGINAL TAPE - OBTURATOR) 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 PRODUCT INVOLVED? CITATION: INT UROGYNECOL J (2014) 25:219¿225; DOI 10.1007/S00192-013-2186-8.

    Description of Event or Problem · 1

    TITLE : SEVEN YEARS OF OBJECTIVE AND SUBJECTIVE OUTCOMES OF TRANSOBTURATOR (TVT-O) VAGINAL TAPE: WHY DO TAPES FAIL? THE PRIMARY AIM OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE LONG-TERM OBJECTIVE AND SUBJECTIVE CURE RATES OF THE TVT-O PROCEDURE IN TREATING STRESS URINARY INCONTINENCE (SUI), TO IDENTIFY ANY RISK FACTORS FOR FAILURE AND THE EFFECTS OF TVT-O ON HEALTH-RELATED QUALITY OF LIFE AND PERIOPERATIVE AND LONG-TERM POSTOPERATIVE COMPLICATIONS. BETWEEN JAN2004 AND JUN2006, 124 FEMALE PATIENTS UNDERWENT A TVT-O PROCEDURE (GYNECARE) WITH OR WITHOUT A CONCOMITANT PELVIC FLOOR RECONSTRUCTIVE SURGERY FOR SUI. IN THE PROCEDURE, THE TVT-O WAS PLACED AFTER COMPLETION OF PROLAPSE SURGERY. PERIOPERATIVE COMPLICATIONS INCLUDED POSTOPERATIVE VOIDING DIFFICULTIES (N=1) THAT REQUIRED TAPE DIVISION, VAGINAL EROSION (N=1) SITUATED ON THE MIDURETHRAL MIDLINE THAT REQUIRED EXCISION OF THE LARGE PART OF THE TAPE, AGGRAVATION OF PRE-EXISTING URGENCY (N=3) AND DE NOVO URGENCY (N=6) WHICH REQUIRED FURTHER INVESTIGATION AND MANAGEMENT. THE AUTHORS HYPOTHESIZE THAT THE RISK FACTORS FOR HIGHER SUBJECTIVE FAILURE OBSERVED IN OUR STUDY COULD BE ATTRIBUTED TO VARIOUS PARAMETERS RELATED TO EITHER SURGICAL TECHNIQUE OR DIFFERENCES IN SUI PATHOPHYSIOLOGY. PERIOPERATIVE AND LONG-TERM POSTOPERATIVE MORBIDITY ASSOCIATED WITH THE TVT-O PROCEDURE WERE UNCOMMON. THE MOST PREVALENT COMPLICATION WAS THE DEVELOPMENT OF DE NOVO URGENCY (7 %), ALTHOUGH SOME OF THOSE WOMEN COULD HAVE NATURALLY DEVELOPED AGE-RELATED URGENCY SYMPTOMS. THIS STUDY REPORTS THE LONG-TERM TVT-O OUTCOMES USING A RETROSPECTIVE DESIGN IN A REAL-LIFE COHORT. IT SHOWS THAT THE TVT-O PROCEDURE PROVIDES HIGH LONG-TERM EFFICACY, CLINICALLY MEANINGFUL IMPROVEMENT IN PATIENTS¿ QUALITY OF LIFE, AND AN EXCELLENT SAFETY PROFILE. HOWEVER, WOMEN WITH CENTRAL COMPARTMENT PROLAPSE AND THOSE UNDERGOING CONCOMITANT VH HAD A HIGHER RISK OF SUBJECTIVE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774802 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention