BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD

    MDR report key: 8043491 · Received November 6, 2018

    Report

    Report Number
    2210968-2018-76983
    Event Type
    Injury
    Date Received
    November 6, 2018
    Report Date
    October 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 (TENSION-FREE VAGINAL TAPE-RETROPUBIC AND 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 PRODUCT INVOLVED? CITATION: INT UROGYNECOL J. 2013; 24: 223¿229. DOI: 10.1007/S00192-012-1840-X. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : ONE-YEAR RESULTS OF A PROSPECTIVE RANDOMIZED, EVALUATOR-BLINDED, MULTICENTER STUDY COMPARING TVT AND TVT SECUR" AUTHOR: MARIA ANDRADA HAMER & PER-GÖRAN LARSSON & PIA TELEMAN & CHRISTINA ETEN BERGQVIST & JAN PERSSON CITATION: INT UROGYNECOL J. 2013; 24: 223¿229. DOI: 10.1007/S00192-012-1840-X. THE AIM OF THIS PROSPECTIVE RANDOMIZED MULTICENTER STUDY WAS TO COMPARE RETROPUBIC TENSION-FREE VAGINAL TAPE (TVT) WITH TVT SECUR IN TERMS OF EFFICACY AND SAFETY. A TOTAL OF 121 PATIENTS WITH PRIMARY STRESS URINARY INCONTINENCE (SUI) OR MIXED URINARY INCONTINENCE (MUI) WITH PREDOMINANT SUI SYMPTOMS UNDERWENT SURGERY AND WERE AVAILABLE FOR FOLLOW-UP. OF WHICH, 61 PATIENTS (AGE RANGE: 33 TO 78 YEARS OLD; BMI: 18.8 TO 36) UNDERWENT TVT (TVT GROUP) AND 60 PATIENTS (AGE RANGE: 33 TO 84 YEARS OLD; BMI: 20.3 TO 42.1) UNDERWENT TVT SECUR PROCEDURE (TVT SECUR GROUP). ALL PATIENTS WERE OPERATED ON AN AMBULATORY BASIS FOLLOWING THE STANDARD TECHNIQUES FOR GYNECARE RETROPUBIC TVT (ETHICON) AND TVT SECUR (ETHICON). PATIENTS WERE OPERATED ON UNDER LOCAL ANESTHESIA USING CARBOCAINE¿ADRENALINE AND SALINE SOLUTION, COMBINED WITH SEDATION WITH FENTANYL AND INTRAVENOUS PROPOFOL. IN THE TVT GROUP, REPORTED COMPLICATIONS INCLUDED VENOUS BLEEDING (N-1) WHICH WAS SOLVED WITH COMPRESSION, EARLY RECURRENCE OF SUI (N-1), DE NOVO URGE SYMPTOMS (N-10), CYSTITIS (N-11), PAIN (N-3), DYSPAREUNIA (N-2), AND MESH EXPOSURE (N-2). IN THE TVT SECUR GROUP, REPORTED COMPLICATIONS INCLUDED BLEEDING FROM CORONA MORTIS (N-1) WHICH REQUIRED IMMEDIATE SURGICAL RE-INTERVENTION WITH EVACUATION OF 1-1 RETROPUBIC HEMATOMA AND VESSEL LIGATURE, VENOUS BLEEDING (N-1) WHICH WAS SOLVED WITH COMPRESSION, TAPE EROSION AND INTENSE URGENCY (N-1) WHICH REQUIRED URETHROCYSTOSCOPY AND A RETROPUBIC TVT PROCEDURE AND THE PATIENT WAS SATISFIED, RECURRENT BACTERURIA AND URGENCY SYMPTOMS (N-1) IN WHICH THE INTRACYSTIC PART OF THE SLING WAS REMOVED BY A COMBINED ENDOSCOPIC AND CYSTOSCOPIC PROCEDURE, WORSENED SUI (N-1), EARLY RECURRENCE OF SUI (N-4), DE NOVO URGE SYMPTOMS (N-7), CYSTITIS (N-13), PAIN (N-2), DYSPAREUNIA (N-3), AND MESH EXPOSURE (N-3). THE TVT SECUR PROCEDURE HAD SIGNIFICANTLY INFERIOR SUBJECTIVE AND OBJECTIVE CURE RATES COMPARED WITH THE RETROPUBIC TVT PROCEDURE. THREE SERIOUS ADVERSE EVENTS OCCURRED IN THE TVT SECUR GROUP. THE AUTHORS THEREFORE DISCOURAGE FURTHER USE OF TVT SECUR. TRADITIONAL RETROPUBIC AND TRANSOBTURATOR APPROACHES ARE WELL STUDIED, EASY TO PERFORM, PROVEN TO BE SAFE, AND HAVE EXCELLENT CURE RATES. THEREFORE, THE AUTHORS BELIEVED THAT SUBURETHRAL (MINI) SLINGS WITH ALTERNATIVE ANCHORING TECHNIQUES SHOULD NOT BE INTRODUCED TO THE MARKET WITHOUT SOLID EVIDENCE ENSURING THAT THEY BRING AN ACTUAL BENEFIT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884478 TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention