BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT

    MDR report key: 7857372 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75727
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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 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: KAOHSIUNG JOURNAL OF MEDICAL SCIENCES. 2014; 30: 139 145. DOI: HTTP://DX.DOI.ORG/10.1016/J.KJMS.2013.09.004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: DIFFERENT SLING PROCEDURES FOR STRESS URINARY INCONTINENCE: A LESSON FROM 453 PATIENTS." AUTHORS: DE-YI LUO, KUN-JIE WANG, HAN-CHAO ZHANG, YI DAI, TONG-XING YANG, HONG SHEN. CITATION: KAOHSIUNG JOURNAL OF MEDICAL SCIENCES. 2014; 30: 139 145. DOI: HTTP://DX.DOI.ORG/10.1016/J.KJMS.2013.09.004. SEVERAL MIDURETHRAL SLING (MUS) PROCEDURES, SUCH AS TENSION-FREE VAGINAL TAPE (TVT), TVT OBTURATOR (TVT-O), TENSION-FREE VAGINAL TAPE SECUR (TVT-S), AND PUBOVAGINAL SLING (PVS), HAVE BEEN USED FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI); HOWEVER, WHICH METHOD IS BEST FOR A PARTICULAR PATIENT GROUP IS NOT KNOWN. THIS STUDY AIMED TO IDENTIFY THE BEST RATIONALE FOR CHOOSING THE OPTIMAL MUS PROCEDURE FOR EACH PATIENT. A TOTAL OF 453 CONSECUTIVE FEMALE PATIENTS WITH SUI WHO WERE TREATED WITH MUSS IN WEST CHINA HOSPITAL OF SICHUAN UNIVERSITY FROM SEPTEMBER 2003 TO SEPTEMBER 2011 WERE ENROLLED IN THIS STUDY. OF WHICH, 105 PATIENTS (AGE: 53.9 ± 14.1; BMI: 24.1 ± 2.0) WERE TREATED WITH TVT (ETHICON), 243 PATIENTS (AGE: 51.1 ± 9.1; BMI: 20.4 ± 2.6) WITH TVT-O (ETHICON), 90 PATIENTS (AGE: 52.4 ± 10.7; BMI: 20.2 ± 2.2) WITH TVT-S (ETHICON), AND 15 PATIENTS (AGE: 45.3 ± 7.2; BMI: 22.7 ± 2.3) WITH PVS. IN THE TVT GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER PERFORATION (N-1), FEVER (N-1), POST-OPERATIVE DE NOVO URGENCY (N-3) WHICH REQUIRED ANTICHOLINERGIC AGENTS AND SHOWED IMPROVEMENT, AND URINARY TRACT INFECTION (N-2). IN THE TVT-O GROUP, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE DE NOVO URGENCY (N-5) WHICH REQUIRED ANTICHOLINERGIC AGENTS AND SHOWED IMPROVEMENT AND URINARY TRACT INFECTION (N-1). IN THE TVT-S GROUP, REPORTED COMPLICATION INCLUDED POST-OPERATIVE DE NOVO URGENCY (N-2) WHICH REQUIRED ANTICHOLINERGIC AGENTS AND SHOWED IMPROVEMENT. SLING SURGERY IS CONSIDERED THE GOLD STANDARD FOR THE TREATMENT OF SUI. THE PLACEMENT OF SLINGS IS TECHNICALLY EASY, THE OPERATION TIME IS SHORT, AND THE FREQUENCY OF COMPLICATIONS IS LOW. MOST IMPORTANTLY, THE CURE RATES OF SLINGS ARE BETWEEN 70% AND 90%, AND THEY REMAIN STABLE OVER TIME. IT WAS CONCLUDED THAT THE SLING PROCEDURES (TVT, TVT-O, TVT-S, AND PVS) ARE SAFE AND REPRODUCIBLY EFFECTIVE. HOWEVER, NO SINGLE SLING PROCEDURE IS UNIVERSALLY SUCCESSFUL FOR ANY OF THE DIFFERENT CONDITIONS ASSOCIATED WITH SUI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695152 TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL PAH ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention