BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 12455534 · Received September 10, 2021

    Report

    Report Number
    2210968-2021-08316
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    January 22, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: THE JOURNAL OF OBSTETRICS AND GYNECOLOGY OF INDIA. HTTPS://DOI.ORG/10.1007/S13224-020-01398-2. 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 (TENSION FREE VAGINAL TAPE ABBREVO) 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 · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SHORT AND LONG TERM FOLLOW UP AND EFFICACY OF TRANS OBTURATOR TAPE FOR MANAGEMENT OF STRESS URINARY INCONTINENCE. THIS STUDY AIMS TO OBSERVE THE MID-TERM AND LONG-TERM SUBJECTIVE AND OBJECTIVE OUTCOMES AND ANY ADVERSE EFFECTS OF THE TRANSOBTURATOR TAPE INSIDE-OUT TECHNIQUE FOR PATIENTS OF PURE SUI OR MIXED INCONTINENCE WITH PREDOMINANT SUI. ROM JANUARY 2011 TO JANUARY 2019, A TOTAL OF 85 AGE RANGE FROM 26 TO 75 YEARS WITH MEAN BEING 45.78 ± 11.25 YEARS, PARITY RANGED FROM 0 TO 6 WITH MEAN BEING 2.68 ± 1.38, WHILE BODY MASS INDEX RANGED FROM 17.8 TO 32.5 KG/M2 WITH MEAN BEING 26.38 ± 2.16 KG/M2 WOMEN WHO WERE DIAGNOSED TO HAVE PREDOMINANT SUI AND WHO UNDERWENT THE TENSION FREE TRANSOBTURATOR TAPE PROCEDURE WERE INCLUDED IN THIS STUDY. GYNECARE TVT- ABBREVO CONTINENCE SYSTEM (ETHICON INC., SOMERVILLE, NJ, USA) WAS USED IN ALL CASES. PATIENTS WERE FOLLOWED UP AT 1 WEEK, 6 WEEKS AND 6 MONTHS AND THEN YEARLY FOR SYMPTOMATIC RELIEF AND ANY COMPLICATIONS. ALL 85 PATIENTS HAD ONE YEAR FOLLOW-UP WHEREAS 48 HAD 3 YEARS FOLLOW UP. REPORTED COMPLICATION INCLUDED: EXCESSIVE BLOOD LOSS (> 100 ML) (N=3). URINARY RETENTION (N=6). URINARY URGENCY (N=7). URINARY TRACT INFECTION (N=2). SURGICAL SITE INFECTION (N=1). GROIN PAIN < 1 WEEK (N=24). PERSISTENT GROIN PAIN (N=4). PARTIAL MESH EROSION IN THE VAGINA WITH THE PATIENTS PRESENTING WITH VAGINAL PAIN, VAGINAL DISCHARGE AND DYSPAREUNIA (N=2), ON EXAMINATION UNDER ANESTHESIA, THE MESH WAS SEEN PARTIALLY EXTRUDING IN THE VAGINA. THE EXPOSED MESH WAS REMOVED UNDER GENERAL ANESTHESIA AND VAGINAL MUCOSA WAS SUTURED OVER THE DEFECT PATIENTS REMAINED CONTINENT THEREAFTER. MESH PERFORATION IN THE BLADDER NECK PRESENTING WITH SLIGHT HEMATURIA AND VAGINAL PAIN (N=1), IT WAS MANAGED BY CYSTOSCOPIC EXCISION OF MESH , PATIENT REMAINED CONTINENT THEREAFTER. FAILURE RATE AT 6 MONTHS RATE (N=4). FAILURE AT 3 YEARS FOLLOW-UP (N=4). RESIDUAL SUI (N=14) WHERE 2 NEEDED SECOND SURGICAL PROCEDURE (BURCH COLPOSUSPENSION WAS DONE), AND 12 PATIENTS REQUIRED FURTHER TREATMENT IN THE FORM OF LIFE STYLE CHANGES, FLUID AND DIET MODIFICATIONS, PELVIC FLOOR EXERCISES AND DULOXETINE THERAPY. IT WAS CONCLUDED, THAT TENSION FREE OBTURATOR TAPE IS AN EFFECTIVE AND SAFE SURGICAL TREATMENT MODALITY FOR SUI. HOWEVER, LARGE MULTICENTRE STUDIES ARE RECOMMENDED BEFORE ITS ROUTINE USE IN CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354030 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention