BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 14265931 · Received May 3, 2022

    Report

    Report Number
    2210968-2022-03187
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    October 28, 2021
    Report Date
    April 30, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 CITE: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2022) 305:407¿413. HTTPS://DOI.ORG/10.1007/S00404-021-06299-X. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 (TVT EXACT RETROPUBIC SYSTEM) 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? PATIENT DEMOGRAPHICS?

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: A RETROSPECTIVE ANALYSIS OF PERIOPERATIVE COMPLICATIONS ASSOCIATED WITH RETROPUBIC TENSION-FREE VAGINAL TAPE IN 960 WOMEN. THE AIM OF THIS STUDY WAS TO ANALYSE THE PERIOPERATIVE COMPLICATIONS OF RETROPUBIC TVT SURGERY AND THEIR MANAGEMENT IN 960 CONSECUTIVE WOMEN OPERATED ON AT ONE INSTITUTION BY ONE SURGEON BETWEEN 2011 AND 2016. WOMEN UNDERGOING SURGERY WITH RETROPUBIC TVT BETWEEN 2011 AND 2016 CARRIED OUT BY ONE SURGEON (CR) AT THE DEPARTMENT OF GYNECOLOGY AND OBSTETRICS TUEBINGEN WERE IDENTIFIED AND THEIR RECORDS WERE REVIEWED RETROSPECTIVELY. THE OPERATIVE REPORTS, AS WELL AS THE POSTOPERATIVE 6-WEEK PERIOD, WERE EXPLORED. A VISIT 6 WEEKS AFTER THE SURGICAL PROCEDURE WAS ATTENDED BY ALL PATIENTS. DATA COLLECTED INCLUDED BASELINE CHARACTERISTICS, THE INDICATION FOR SURGERY (STRESS INCONTINENCE OR MIXED INCONTINENCE WITH A PREDOMINANT STRESS COMPONENT), THE PRESENCE OF PRIMARY OR RECURRENT INCONTINENCE, PREVIOUS UROGYNECOLOGICAL SURGERIES, ADDITIONAL SURGERIES PERFORMED AT THE SAME TIME WITH THE TVT PROCEDURE, TYPE OF ANESTHESIA, OPERATING TIME, TYPE OF THE INSERTED RETROPUBIC TVT (TVT EXACT®, ETHICON INC. REPORTED COMPLICATIONS INCLUDED BLADDER PERFORATION (N=1) BLADDER LESION OF 5 MM LENGTH (N=1), VOIDING PROBLEMS AND RESIDUAL URINE (N=41),STRESS URINARY INCONTINENCE (N=1), HEMATOMAS IN THE RETZIUS' SPACE OCCURRED (N=4), URINARY TRACT INFECTIONS (N=10), VAGINAL BLEEDING POSTOPERATIVELY, (N=4), VAGINAL EROSION OCCURRED. (N=1), URGE INCONTINENCE AND SUPRAPUBIC PAIN. IN CONCLUSION THE RESULTS OF THE STUDY SHOW THAT THE RETROPUBIC TVT IS ACCOMPANIED BY A LOW NUMBER OF COMPLICATIONS WHEN PERFORMED BY AN EXPERIENCED SURGEON. WE REGARD THE RETROPUBIC TVT PROCEDURE UNDER ANALGOSEDATION AS A VERY FEASIBLE SURGICAL THERAPY FOR WOMEN AFFECTED BY STRESS URINARY INCONTINENCE OR MIXED INCONTINENCE WITH A DOMINANT STRESS COMPONENT. IN SPITE OF SLIGHTLY HIGHER COMPLICATION RATES IN OLDER AND OVERWEIGHTED PATIENTS AS WELL AS IN PATIENTS WITH RECURRENT STRESS INCONTINENCE, THE OVERALL NUMBER OF COMPLICATIONS WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118143 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTRL 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention