BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7939137 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76341
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. 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 PRODUCT (TENSION FREE VAGINAL TAPE ) 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? CITATION: WORLD J UROL (2016) 34:585¿593; DOI 10.1007/S00345-015-1651-Z . (B)(4).

    Description of Event or Problem · 1

    TITLE : LONG-TERM EFFICACY OF THE TRANS-OBTURATOR AND RETROPUBIC MID-URETHRAL SLINGS FOR STRESS URINARY INCONTINENCE: UPDATE FROM A RANDOMIZED CLINICAL TRIAL. THIS PROSPECTIVE, MULTICENTER RANDOMIZED CLINICAL TRIAL AIMED TO REPORT THE EXTENDED LONG-TERM RESULTS OF THE USE OF TENSION-FREE VAGINAL TAPE (TVT) AND TRANS-OBTURATOR TAPE (TOT) FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI). ON THE CLINICAL ASSESSMENT BETWEEN OCT2012 AND JUN2013, 87 FEMALE PATIENTS WITH SUI UNDERWENT SURGERY OF EITHER TVT (N=40; MEDIAN AGE OF 60.9 YEARS [RANGED 40-91 YEARS]) OR TOT (N=47; MEDIAN AGE OF 59 [RANGED 42-79 YEARS]). IN TVT GROUP, TVT GYNECARE WAS USED. POSTOPERATIVE MEAN VAS SCORE OF 8.2 ± 2.1 WAS REPORTED IN 35 PATIENTS IN TVT GROUP. IN THE FOLLOW-UP PERIOD UNDER TVT GROUP, ONE PATIENT DEVELOPED PELVIC ORGAN PROLAPSE (POP), ONE PATIENT HAD PARA-INCISIONAL HERNIA, AND ANOTHER PATIENT HAD SUPRAPUBIC GRANULOMA. ALL THREE PATIENT UNDERWENT REINTERVENTION. ADDITIONALLY, EIGHT PATIENTS FROM THIS GROUP DEVELOPED SPORADIC UNCOMPLICATED URINARY TRACT INFECTIONS. THE LONG-TERM FINDINGS (PRESENCE OF STORAGE SYMPTOMS IN 20 % OF THE TOT GROUP AND 36.8 % OF THE TVT GROUP) AND THE KAPLAN¿MEIER CURVE, DESCRIBING THE ONSET OF POST-OPERATIVE STORAGE SYMPTOMS, CONFIRMED THE RELEVANCE OF THIS PROBLEM AND HOW IT TENDS TO WORSEN OVER TIME. THIS DOES NOT SEEM TO BE RELATED TO THE ANTI-INCONTINENCE PROCEDURE, BECAUSE WE CANNOT EXCLUDE THE POSSIBILITY THAT A CERTAIN PERCENTAGE OF WOMEN MAY NATURALLY DEVELOP OAB SYMPTOMS DUE TO THEIR AGEING AND OTHER COMORBIDITIES WITH THEIR CONFOUNDING ROLES. SIMILAR CONSIDERATION WAS MADE AT THE ONSET OF POST-OPERATIVE VOIDING SYMPTOMS AS THEY WORSENED WITHIN THE FIRST FEW MONTHS AFTER THE PROCEDURE, STABILIZED UP UNTIL 75 MONTHS, AND THEN TENDED TO WORSEN OVER TIME, CLEARLY RELATED TO OTHER FACTORS. THE VOIDING SYMPTOMS COULD BE RELATED TO FACTORS NOT DEPENDENT ON ANTI-INCONTINENCE SURGERY SUCH AS NORMAL AGEING DETRUSOR PROCESS OR NEW PATHOLOGIES THAT OCCURRED DURING THE FOLLOW UP (VAGINAL PROLAPSE, STROKE, PARKINSON¿S DISEASE, MYELOMA, KIDNEY TUMOUR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780590 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention