BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 8226420 · Received January 8, 2019

    Report

    Report Number
    2210968-2019-78260
    Event Type
    Injury
    Date Received
    January 8, 2019
    Report Date
    December 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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 (TVT-OBTURATOR, TVT-SECUR) 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 (TVT-OBTURATOR, TVT-SECUR) USED IN THIS PROCEDURE? CITATION: MENOPAUSE: THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY VOL. 21, NO. 6, PP. 641/645; DOI: 10.1097/GME.0000000000000119. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: OUTCOME AND SEXUAL FUNCTION AFTER TRANSOBTURATOR TAPE PROCEDURE VERSUS TENSION-FREE VAGINAL TAPE SECUR: A RANDOMIZED CONTROLLED TRIAL¿. AUTHOR(S): XIANG TANG, PHD, MD, LAN ZHU, MD, SHUO LIANG, MD, AND JINGHE LANG, MD. CITATION: MENOPAUSE: THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY VOL. 21, NO. 6, PP. 641/645; DOI: 10.1097/GME.0000000000000119. THIS RANDOMIZED, NON-BLINDED PROSPECTIVE STUDY AIMED TO COMPARE THE EFFICACY, SAFETY, AND SEXUAL FUNCTION BETWEEN INSIDE-OUT TRANSOBTURATOR TAPE (TVT-O) AND TENSION-FREE VAGINAL TAPE SECUR (TVT-S) PROCEDURES FOR STRESS URINARY INCONTINENCE (SUI) TREATMENT. FROM OCT2008 TO OCT2010, 81 FEMALE PATIENTS WITH DEMONSTRABLE SUI WHO UNDERWENT EITHER TVT-O (MEAN AGE SD OF 51.3 YEARS [7.5 YEARS]) OR TVT-S (MEAN AGE OF 49.8 YEARS [10.1 YEARS]) WERE INCLUDED IN THE ANALYSIS. IN BOTH PROCEDURES, THE NEEDLES AND WOVEN POLYPROPYLENE TAPES WERE GYNECARE PRODUCTS (ETHICON INC). THE TVT-O AND TVT-S PROCEDURES WERE PERFORMED ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. POSTOPERATIVELY, COMPLICATIONS INCLUDED HEMATOMA (N=2 TVT-O) WHICH NONE REQUIRED BLOOD TRANSFUSION OR SURGICAL INTERVENTION, URINARY RETENTION (N=1 TVT-O AND N=1 TVT-S), DE NOVO URINARY URGENCY (N=2 TVT-O AND N=2 TVT-S), TAPE EROSION (N=3 TVT-O AND N=1 TVT-S), GROIN/THIGH PAIN (N=8 TVT-O AND N=1 TVT-S) WHICH NONE REQUIRED ANALGESICS DRUGS, AND DYSPAREUNIA (N=3 TVT-O AND N=1 TVT-S). IN A 24-MONTH FOLLOW-UP, FAILURE WAS RECORDED IN 5 PATIENTS FROM TVT-O GROUP AND 6 PATIENTS FROM TVT-S GROUP. THE CAUSE OF THIS PAIN IS UNCLEAR BUT MAY BE RELATED TO DAMAGE TO THE POSTERIOR DIVISION OF THE OBTURATOR NERVE OR ADDUCTOR MUSCLES. THE TVT-O AND TVT-S PROCEDURES ARE EFFECTIVE IN CHINESE WOMEN WITH SUI ACROSS 2 YEARS OF FOLLOW-UP. THE OPERATIVE TIME IS SHORTER, AND THE RATE OF POSTOPERATIVE GROIN/THIGH PAIN IS LOWER FOR PATIENTS UNDERGOING THE TVT-S PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20195 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention