BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 11740515 · Received April 28, 2021

    Report

    Report Number
    2210968-2021-03953
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    September 24, 2010
    Report Date
    April 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CITATION: BJOG. 2010; 117:1493¿1503. DOI: 10.1111/J.1471-0528.2010.02696.X.

    Description of Event or Problem · 1

    TITLE: A RANDOMISED CONTROLLED TRIAL COMPARING TVTTM, PELVICOLTM AND AUTOLOGOUS FASCIAL SLINGS FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN WOMEN. THE AIM OF THIS MULTICENTRE RANDOMISED CONTROL TRIAL IS TO COMPARE THE EFFICACY AND MORBIDITY OF THREE DIFFERENT MATERIALS USED FOR MIDURETHRAL SLING SURGERY IN WOMEN REQUIRING PRIMARY SURGERY FOR SUI. BETWEEN 2001 TO 2006, A TOTAL OF 201 FEMALE PATIENTS WITH URODYNAMICALLY PROVEN STRESS INCONTINENCE WERE RANDOMISED INTO THREE GROUPS. OF THESE, 72 FEMALE PATIENTS (MEAN AGE = 54.3 YEARS; AGE RANGE = 34¿80 YEARS) WERE TREATED USING TYPE-1 POLYPROPYLENE MESH (TVT; GYNECARE, ETHICON). REPORTED COMPLICATIONS INCLUDED IN THE TVT GROUP WERE INTERMITTENT SELF CATHETERISATION (ISC) AT 6 WEEKS (N=1.5%); DAYTIME FREQUENCY OF >7 (N=48%); URGE INCONTINENCE (N=73%); FREQUENCY OF INCONTINENCE (N=63%); STRESS INCONTINENCE (N=50%); UNEXPLAINED INCONTINENCE (N=27%); BLADDER INJURY (N=4); NON-IMPROVED RATES (N=?); AND WET RATES (N=?). IN CONCLUSION, OUR STUDY INDICATES THAT PELVICOL IS AN INFERIOR MATERIAL FOR MID-URETHRAL SLING SUPPORT, AND THIS CANNOT BE RECOMMENDED FOR THE MANAGEMENT OF SUI IN WOMEN. THE MIDURETHRAL BOTTOM-UP TYPE-1 POLYPROPYLENE MESH (TVT) YIELDED SIMILAR RESULTS TO MID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632973 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention