BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7935445 · Received October 4, 2018

    Report

    Report Number
    2210968-2018-76322
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL; DOI: HTTPS://DOI.ORG/10.1007/S00192-018-3713-4 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : ASSESSMENT OF THE LONG-TERM OUTCOME OF TVT PROCEDURE FOR STRESS URINARY INCONTINENCE IN A FEMALE POPULATION: RESULTS AT 17 YEARS¿ FOLLOW-UP" AUTHOR: PANAGIOTIS BAKAS, EMMANOUEL PAPADAKIS, CHARALAMPOS KARACHALIOS, ILIAS LIAPIS, NIKOLAOS PANAGOPOULOS, AGGELOS LIAPIS CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL; DOI: HTTPS://DOI.ORG/10.1007/S00192-018-3713-4 THE AIM OF THIS PROSPECTIVE STUDY WAS TO ASSESS THE OUTCOME OF THE TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE IN PATIENTS WHO HAD UNDERGONE THE TVT PROCEDURE FOR THE MANAGEMENT OF URODYNAMIC STRESS URINARY INCONTINENCE 17 YEARS AGO. AT THE 17 YEARS FOLLOW-UP, 56 FEMALE PATIENTS WHO HAD UNDERGONE TVT PROCEDURE FOR THE MANAGEMENT OF URODYNAMIC STRESS URINARY INCONTINENCE WERE INCLUDED. THE TVT PROCEDURE WAS CARRIED OUT WITH TVT (GYNECARE ¿ ETHICON). AT THE FOLLOW-UP PERIOD, TWO PATIENTS REPORTED RECURRENT URINARY TRACT INFECTION WHICH WERE TREATED WITH ANTIBIOTIC THERAPY±PROPHYLALXIS, AND ONE PATIENT HAD TVT EROSION FULLY DEVELOPED AT 29 MONTHS POST-PROCEDURE WHICH WAS TREATED BY CUTTING OF THE PROJECTING EDGES OF TAPE INTO THE VAGINA AND LOCAL ESTROGENS. SUBJECTIVE FAILURE WAS REPORTED BY 7 PATIENTS. THE INCREASE IN THE INCIDENCE OF THE DE NOVO DEVELOPMENT OF OAB SYMPTOMS COULD BE ATTRIBUTED TO THE INCREASED PATIENT¿S AGE. THE POSSIBLE EXPLANATION OF THE PATIENTS WHO REPORTED DIFFICULTY EMPTYING THE BLADDER COULD BE LOCAL CHANGES IN SENSATION SECONDARY TO MENOPAUSE. THE TVT PROCEDURE FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN WOMEN MAINTAINS ITS EFFICACY IN THE LONG TERM, HAVING AN OBJECTIVE CURE RATE OF 83.9% AND A SUBJECTIVE CURE RATE OF 78.6% AT 17 YEARS¿ FOLLOW-UP, WITH A VERY LOW COMPLICATIONS RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776215 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention