BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 11688784 · Received April 19, 2021

    Report

    Report Number
    2210968-2021-03505
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    January 1, 2003
    Report Date
    April 2, 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
    FI
    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. EVENTS RELATED TO 4-0 VICRYL SUTURE CAPTURE VIA 2210968-2021-03506. CITATION: ACTA OBSTET GYNECOL SCAND 2003; 82: 665¿671. # ACTA OBSTET GYNECOL SCAND 82 2003.

    Description of Event or Problem · 1

    TITLE: TENSION-FREE VAGINAL TAPE AND LAPAROSCOPIC MESH COLPOSUSPENSION IN THE TREATMENT OF STRESS URINARY INCONTINENCE: IMMEDIATE OUTCOME AND COMPLICATIONS A RANDOMIZED CLINICAL TRIAL THIS STUDY AIMED TO EVALUATE THE IMMEDIATE OUTCOME AND COMPLICATIONS OF THE TENSION-FREE VAGINAL TAPE (TVT) AND LAPAROSCOPIC MESH COLPOSUSPENSION (LC) PROCEDURES IN THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI). A TOTAL OF 121 PATIENTS WERE OPERATED UPON: PATIENTS IN THE TVT GROUP AND 51 IN THE LC GROUP. WITH A TVT NEEDLE (TVT DEVICE, GYNECARE, JOHNSSON & JOHNSSON, SOMERVILLE, NJ, USA) THE UROGENITAL DIAPHRAGM WAS PERFORATED AND THE TIP OF THE NEEDLE WAS BROUGHT UP TO ONE OF THE ABDOMINAL INCISIONS. THE PROCEDURE WAS THEN REPEATED ON THE OTHER SIDE. THE BLADDER WAS THEN EMPTIED AND THE INCISIONS SUTURED WITH 4-0 VICRYL (ETHICON).THE PATIENTS WERE EVALUATED ACCORDING TO THE STUDY PROTOCOL BEFORE OPERATION AND 6 WEEKS AFTER IT. THE INDEPENDENT SAMPLE T-TEST AND THE MANN¿WHITNEY U-TEST WERE USED TO CALCULATE STATISTICAL DIFFERENCES BETWEEN THE STUDY GROUPS. REPORTED EVENT IN THE TVT GROUP INCLUDED BLOOD LOSS (N=34), BLADDER PERFORATION (N=1), PROLONGED RETENTION (N=2), WOUND INFECTION (N=1), URINARY TRACT INFECTION (N=3) AND URGE SYMPTOMS (N=2). A PATIENT WITH PROLONGED RETENTION IN TVT GROUP WAS MANAGED BY SELF-CATHETERIZATION FOR 6 DAYS. AT THE 6-WEEK FOLLOW-UP VISIT THE RESIDUAL URINE VOLUME WAS 35ML AND THE PATIENT REPORTED NO VOIDING PROBLEMS. WOUND INFECTION WAS CURED WITH ORAL ANTIBIOTICS. IMMEDIATE CURE RATES, DEFINED AS NEGATIVE STRESS TEST WITH 300ML SALINE IN THE BLADDER, WERE SIMILAR (92.9% IN THE TVT GROUP AND 88.2% IN THE LC GROUP; P¼NS). RETURN TO NORMAL VOIDING WAS FASTER IN THE TVT GROUP (9.2 H IN THE TVT GROUP VS. 24.4 H IN THE LC GROUP; P¼0.004). FEWER ANALGESICS WERE USED IN THE TVT GROUP AND HOSPITAL STAY WAS SHORTER IN THIS GROUP. COMPLICATION RATES ASSOCIATED WITH THE PROCEDURES WERE SIMILAR AND THE NUMBER OF COMPLICATIONS WAS SMALL. IN CONCLUSION, THE IMMEDIATE OUTCOME OF BOTH PROCEDURES IS THE SAME. THE RATES OF COMPLICATIONS WERE SIMILAR. HOWEVER, THE TVT PROCEDURE SEEMS TO BE LESS INVASIVE AND REQUIRES FEVER HOSPITAL RESOURCES THAN LC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587077 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention