BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11906374 · Received May 31, 2021

    Report

    Report Number
    2210968-2021-05089
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    July 17, 2015
    Report Date
    May 3, 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
    HK
    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. CITATION: HONG KONG MED J 2015;21:333¿8, DOI: 10.12809/HKMJ144397. 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 THE ETHICON PRODUCT (TENSION FREE VAGINAL TAPE - OBTURATOR) 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: EFFICACY AND OUTCOMES OF TRANS OBTURATOR TENSION FREE VAGINAL TAPE WITH OR WITHOUT CONCOMITANT PELVIC FLOOR REPAIR SURGERY FOR URINARY STRESS INCONTINENCE: FIVE-YEAR FOLLOW-UP. THIS STUDY AIMED TO COMPARE THE 5-YEAR SUBJECTIVE AND OBJECTIVE OUTCOMES OF TRANS OBTURATOR TENSION FREE VAGINAL TAPE ALONE VERSUS THE SAME PROCEDURE WITH CONCOMITANT PELVIC FLOOR REPAIR SURGERY FOR PELVIC ORGAN PROLAPSE IN WOMEN WITH URINARY STRESS INCONTINENCE. THERE WERE 218 WOMEN WITH USI WHO RECEIVED TO-TVT BETWEEN 1 SEPTEMBER 2004 AND 31 DECEMBER 2009. WOMEN WITH USI WHO DID NOT IMPROVE AFTER PELVIC FLOOR EXERCISE WERE OFFERED TO-TVT. WOMEN WHO HAD USI ONLY UNDERWENT TO-TVT SURGERY, WHILE WOMEN WITH BOTH USI AND POP RECEIVED TO-TVT AND CONCOMITANT PFR SURGERY. THE PFR SURGERY WAS USUALLY VAGINAL HYSTERECTOMY WITH ANTERIOR COLPORRHAPHY. WOMEN HAD EITHER TOT (OUTSIDE-IN TECHNIQUE; MONARC SUBFASCIAL HAMMOCK, AMERICAN MEDICAL SYSTEMS INC., MINNETONKA [MN], US) PERFORMED FROM SEPTEMBER 2004 TO JUNE 2006 OR TVT-O (INSIDE-OUT TECHNIQUE; GYNECARE TVT OBTURATOR SYSTEM, ETHICON INC [NJ], US) PERFORMED FROM JULY 2006 TO DECEMBER 2009 IN THE SAME URO-GYNECOLOGY CENTRE. THE CHANGE FROM TOT TO TVT-O WAS BECAUSE TVT-O WAS BECOMING AVAILABLE. THE 5-YEAR SUBJECTIVE AND OBJECTIVE CURE RATES WERE ASSESSED. SUBJECTIVE CURE WAS DEFINED AS NO URINE LOSS DURING PHYSICAL ACTIVITY AND OBJECTIVE CURE WAS DEFINED AS NO URINE LEAKAGE ON COUGHING DURING URODYNAMIC STUDY. OVERALL, 88 WOMEN RECEIVING TRANS OBTURATOR TENSION-FREE VAGINAL TAPE ALONE AND 101 WOMEN RECEIVING TRANS OBTURATOR TENSION-FREE VAGINAL TAPE WITH CONCOMITANT PELVIC FLOOR REPAIR SURGERY WERE FOLLOWED UP FOR 5 YEARS AFTER OPERATION. THE SUBJECTIVE AND OBJECTIVE CURE RATES OF THE TWO GROUPS WERE 70.5% VERSUS 94.1% (P<0.01) AND 80.3% VERSUS 85.7% (P=0.58), RESPECTIVELY. REPORTED COMPLICATIONS IN THE TO-TVT ONLY GROUP INCLUDED TAPE EROSION WITH VAGINAL PAIN (N=1), VOIDING DIFFICULTY WITH OAB SYMPTOMS (N=2) AND GROIN PAIN 4YEARS AFTER THE OPERATION (N=1) WHICH WAS TREATED CONSERVATIVELY WITH ANALGESICS. REPORTED COMPLICATIONS IN THE TO-TVT WITH CONCOMITANT PFR SURGERY GROUP INCLUDED TAPE EROSION WITH VAGINAL PAIN (N=2). EXPOSED TAPE WAS CUT AND THE VAGINAL SKIN WAS REPAIRED UNDER LOCAL OR REGIONAL ANESTHESIA. NO RECURRENCE OF USI AFTER TAPE EXCISION AT THE 5-YEAR FOLLOW-UP. FOR PATIENTS WITH VOIDING DIFFICULTY T APE WAS CUT AT 4MONTHS & 18 MONTHS RESPECTIVELY. THEIR VOIDING PROBLEM WAS RESOLVED AND BOTH HAD NO RECURRENCE OF USI AFTER TAPE RELEASE. IN CONCLUSION, TRANS OBTURATOR TENSION-FREE VAGINAL TAPE IS AN EFFECTIVE TREATMENT FOR URINARY STRESS INCONTINENCE IN WOMEN WHO RECEIVED IT ALONE OR WITH CONCOMITANT PELVIC FLOOR REPAIR SURGERY FOR PELVIC ORGAN PROLAPSE, PROVIDING HIGH SUBJECTIVE AND OBJECTIVE EFFICACY FOR UP TO 5 YEARS AFTER OPERATION. TRANS OBTURATOR TENSION-FREE VAGINAL TAPE WITH CONCOMITANT PELVIC FLOOR REPAIR SURGERY ACHIEVED SIMILAR, IF NOT BETTER, LONG-TERM OUTCOME COMPARED WITH TRANS OBTURATOR TENSION-FREE VAGINAL TAPE ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802833 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention