BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    MDR report key: 10057661 · Received May 14, 2020

    Report

    Report Number
    2210968-2020-03929
    Event Type
    Injury
    Date Received
    May 14, 2020
    Report Date
    April 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (TVT/TVT-EXACT) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? ETHICON PRODUCTS INVOLVED CONTRIBUTED TO SOME OF THE POST-OPERATIVE COMPLICATIONS REPORTED WHILE NOT TO OTHER (SOME PROCEDURES WERE PERFORMED WITH BARD PRODUCTS). PLEASE NOTE THAT ALL THE PROCEDURES DESCRIBED WERE DONE IN WOMEN WITH A PREVIOUS FAILED TRANSOBTURATOR-SUBURETHRAL TAPE. FOR THAT REASON, THE COMPLICATIONS DESCRIBED PROBABLY COULD NOT ONLY BE ATTRIBUTED TO RETROPUBIC SLINGS BUT TO THE INTERACTION OF BOTH SLINGS. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (TVT/TVT-EXACT) USED IN THIS PROCEDURE? NO. ALL THE COMPLICATIONS REPORTED WERE THOSE EXPECTED WITH THIS PROCEDURE AND SURGICAL ROUTE. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? NO. PATIENT DEMOGRAPHICS? PATIENT DEMOGRAPHICS ARE ONLY AS DESCRIBED IN THE ARTICLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ADVERSE EVENTS REGARDING TVT SUBMITTED VIA 2210968-2020-03928 ADVERSE EVENTS REGARDING TVT EXACT SUBMITTED. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL / HTTPS://DOI.ORG/10.1007/S00192-019-04169-4. (B)(4).

    Description of Event or Problem · 1

    TITLE: LONG-TERM OUTCOMES OF RETROPUBIC TENSION-FREE VAGINAL TAPE FOR STRESS URINARY INCONTINENCE AFTER A TRANSOBTURATOR TAPE FAILURE: A RETROSPECTIVE STUDY THE PURPOSE OF THIS DESCRIPTIVE RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF RETROPUBIC TENSION-FREE VAGINAL TAPE (RP-TVT) IN THE TREATMENT OF PERSISTENT/RECURRENT STRESS URINARY INCONTINENCE (SUI) AFTER A TRANSOBTURATOR TAPE (TOT) FAILURE IN A COHORT WITH LONG-TERM FOLLOW-UP. BETWEEN JANUARY 2006 AND DECEMBER 2014, A TOTAL OF 41 WOMEN (MEDIAN AGE 62.7 YEARS [47.8¿81.0 YEARS], MEDIAN BMI 29.6 [22¿45]) WITH SUI AFTER A TOT FAILURE TREATED SECONDARILY WITH A RP-TVT PROCEDURE WERE INCLUDED IN THE STUDY. THE RETROPUBIC SUBURETHRAL DEVICES USED WERE TVT/TVTEXACT (GYNECARE, ETHICON) AND URETEX-SUP/ALIGN R (BARD, CRAWLEY, UK). SLING TYPE WAS CHOSEN ACCORDING TO THE SURGEON¿S PREFERENCE AND BY ITS AVAILABILITY. INTRAOPERATIVE COMPLICATION INCLUDED BLADDER PERFORATION (N=4). EARLY POSTOPERATIVE COMPLICATIONS CYSTITS (N=6), VOIDING DIFFICULTY (N=7) REQUIRING INTERMITTENT SELF-CATHETERIZATION (ISC), HEMATOMA (N=2), AND SHORT-TERM SUPRAPUBIC/THIGH PAIN (N=3). LATE POSTOPERATIVE COMPLICATIONS VOIDING DYSFUNCTION (N=3), RECURRENT CYSTITIS (N=4), VAGINAL SLING EXPOSURE (N=2) TREATED WITH LOCAL ESTROGENS, AND LUT SLING EXTRUSION (N=3) WHICH REQUIRED AN INCISION OR EXCISION OF THE RP-TVT, DE NOVO URGENCY (N=7), URINARY OBSTRUCTIVE SYMPTOMS (N=2) WHICH REQUIRED AN INCISION OR EXCISION OF THE RP-TVT, AND BLADDER NECK LESION (N=1) THAT REQUIRED AN INCISION OR EXCISION OF THE RP-TVT. FAILURES INCLUDED PERSISTENT SUI (N=2), SEVERE URGENCY URINARY INCONTINENCE (UUI) (N=2), AND MIXED URINARY INCONTINENCE (MUI) (N=9). RP-TVT SHOWED REASONABLE LONG-TERM EFFECTIVENESS BUT HAD A HIGH OVERALL COMPLICATION RATE IN THE TREATMENT OF PERSISTENT/RECURRENT SUI AFTER TOT. EXPECTED OUTCOMES AND POSSIBLE SIDE EFFECTS SHOULD BE DISCUSSED IN DETAIL DURING COUNSELING BEFORE OPTING FOR A TREATMENT OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521029 TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention