BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11752710 · Received April 30, 2021

    Report

    Report Number
    2210968-2021-04098
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    March 2, 2011
    Report Date
    April 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: INT UROGYNECOL J; DOI 10.1007/S00192-011-1380-9. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: CONTASURE-NEEDLELESS® COMPARED WITH TRANSOBTURATOR-TVT® FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE MAIN OBJECTIVE OF THIS STUDY IS TO ASSESS WHETHER OR NOT THE CONTASURE-NEEDLELESS® (C-NDL®) SLING IS INFERIOR TO TRANSOBTURATOR VAGINAL TAPE (TVT®-O) MESH IN THE TREATMENT OF STRESS URINARY INCONTINENCE IN PATIENTS WITH OR WITHOUT ASSOCIATED PELVIC ORGAN PROLAPSE. FROM SEPTEMBER 2006 TO JULY 2009, 158 WOMEN WITH AFFECTED BY STRESS URINARY INCONTINENCE WITH POSITIVE STRESS TEST, WITH OR WITHOUT ASSOCIATED GENITAL PROLAPSE AND WHO ARE CANDIDATES FOR SURGICAL TREATMENT. THE PATIENTS WERE ASSIGNED TO ONE OR ANOTHER GROUP OF TREATMENT DEPENDING ON THE LAST FIGURE OF THEIR MEDICAL HISTORY NUMBER; LAST EVEN FIGURE WAS ALLOCATED FOR TECHNICAL TVT®-O AND LAST ODD FIGURE FOR C-NDL®. A TOTAL OF 26 PATIENTS (11 IN THE TVT®-O GROUP AND 15 IN THE C-NDL® GROUP), DID NOT COMPLETE THE FOLLOW-UP SCHEDULE AND THUS WERE CONSIDERED EXCLUDED FROM THE STUDY. THIS LEFT A TOTAL OF 60 PATIENTS (MEAN AGE 60.6 YEARS, RANGE 40-85; MEAN BMI 29.01, RANGE 19.5-42.1) IN THE TVT®-O GROUP AND 72 IN THE C-NDL® GROUP. ALL PATIENTS IN THE TVT-O GROUP RECEIVED THE 450×11 MM TRANSOBTURATOR VAGINAL TAPE (TVT®-O) MESH (ETHICON) FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. MEANWHILE THE C-NDL® GROUP RECEIVED THE CONTASURE-NEEDLELESS® (C-NDL®) SLING, A COMPETITOR'S DEVICE. SURGICAL PROCEDURE OF PURE INCONTINENCE WAS PERFORMED IN 55 PATIENTS (34.8%), 34 IN THE C-NDL® GROUP AND 21 IN THE TVT®-O GROUP. THE REMAINING PATIENTS UNDERWENT GENITAL PROLAPSE ASSOCIATED INTERVENTIONS. ALL PATIENTS ARE MONITORED AT INTERVALS OF 1 MONTH, 3 MONTHS, 6 MONTHS AND ANNUALLY AFTER SURGERY. A UROGYNECOLOGICAL EXAMINATION IS PERFORMED WHICH INCLUDES: ASSESSMENT OF EXTERNAL GENITALIA, STRESS TEST AND COMPLETION OF TWO QUESTIONNAIRES: THE ICI-Q SHORT FORM QUALITY OF LIFE AND THE SANDVIK SEVERITY TEST. COMPLICATIONS IN THE TVT®-O GROUP INCLUDE INTRAOPERATIVE BLADDER INJURY (N=1), POST OPERATIVE PAIN OF >5 IN VAS (N=7) DURING THE FIRST DAY OF AFTER PROCEDURE, URINARY RETENTION (N=3); DE NOVO URGE INCONTINENCE (N=10), DIFFICULTY IN URINATION (N=1), MESH EXTRUSION (N=1), RECURRENT URINARY TRACT INFECTIONS (N=1), AND NON NEGATIVE STRESS TEST (AS CURE RATE/NEGATIVE STRESS TEST N=54/60 (90%)) AT 12 MONTHS FOLLOW-UP. IN CONCLUSION, OUR EXPERIENCE AND THE RESULTS IN 1-YEAR FOLLOW-UP OF NON-INFERIORITY OF THE C-NDL® COMPARED TO TVT-O®, DEMONSTRATE THAT IT IS A SAFE TECHNIQUE, REPRODUCIBLE, AND ACCOMPLISHES THE GOAL OF MINIMALLY INVASIVE SURGERY. ADDITIONALLY, IT WIDENS THE SURGICAL ARMAMENTARIUM TO TREAT URINARY STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653558 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention