BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 11750544 · Received April 29, 2021

    Report

    Report Number
    2210968-2021-04067
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 16, 2011
    Report Date
    March 30, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    N/A
    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.¿ THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.¿ CITATION: INT UROGYNECOL J (2011); 22:781787. DOI 10.1007/S00192-011-1381-8 ¿ TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENT RELATED TO TVT-SECUR DEVICE REPORTED VIA MW # 2210968-2021-04066.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SHORT-TERM RESULTS OF A PROSPECTIVE RANDOMIZED EVALUATOR BLINDED MULTICENTER STUDY COMPARING TVT AND TVT-SECUR. THE AIM OF THIS PROSPECTIVE RANDOMIZED MULTICENTER STUDY WAS TO COMPARE TVT (TENSION-FREE VAGINAL TAPE) WITH TVT-SECUR IN TERMS OF EFFICACY AND SAFETY. BETWEEN 2007 TO 2009, A TOTAL OF 123 FEMALE PATIENTS WITH PRIMARY SUI OR MIXED URINARY INCONTINENCE WITH PREDOMINANT SUI SYMPTOMS WERE INCLUDED IN THE STUDY. OF THESE, 62 PATIENTS (MEDIAN AGE = 48 YEARS; AGE RANGE = 3378 YEARS) WERE TREATED USING TECHNIQUES FOR TVT (GYNECARE, ETHICON) IN THE TVT GROUP WHILE 61 PATIENTS (MEDIAN AGE = 47 YEARS; AGE RANGE = 3384 YEARS) WERE TREATED WITH TVT-SECUR SYSTEM (GYNECARE, ETHICON) IN THE TVT-SECUR GROUP. REPORTED COMPLICATIONS INCLUDED IN THE TVT-SECUR GROUP WERE VOIDING DIFFICULTIES (N=2) WHICH REQUIRED INTERMITTENT CATHETERIZATION FOR 2 DAYS AND 7 DAYS, RESPECTIVELY; ACCIDENTAL PERFORATIONS OF THE VAGINAL WALL BESIDE THE INCISION (N=1); BLEEDING BETWEEN 100 AND 200 ML (N=1); INJURY OF THE CORONA MORTIS (N=1) WHICH REQUIRED IMMEDIATE SURGICAL REINTERVENTION WITH EVACUATION OF A 1 L RETROPUBIC HEMATOMA AND VESSEL LIGATURE; TAPE EROSION INTO THE URETHRA WITH INTENSE URGENCY SHORTLY AFTER SURGERY AND SLIGHT HEMATURIA (N=1), AFTER AN INITIAL EXPECTANT MANAGEMENT, THE SLING WAS REMOVED BY URETROSCOPY 22 MONTHS AFTER SURGERY RESULTING IN AN SUI RECURRENCE (NOT INCLUDED AS A FAILURE IN SHORT-TERM ANALYSIS); A TAPE INADVERTENTLY PLACED INSIDE THE BLADDER, WITH RECURRENT BACTERIURIA AND URGENCY SYMPTOMS (N=1) WHICH REQUIRED REMOVAL OF THE INTRACYSTIC PART OF THE SLING BY A COMBINED ENDOSCOPIC AND CYSTOSCOPIC PROCEDURE; THE SUBJECTIVE OUTCOME WERE SLIGHTLY IMPROVED (N=10), UNCHANGED (N=5), WORSENED (N=2); OVERACTIVE BLADDER/DE NOVO URGENCY WERE MILD (N=4), MODERATE (N=8), SEVERE (N=2), UNCHANGED (N=6); POSTOPERATIVE CYSTITIS WITH 1-2 EPISODES (N=6) AND 3-4 EPISODES (N=3). IN THE TVT GROUP WERE BLEEDING FROM THE CORONA MORTIS (N=1) WHICH REQUIRED REOPERATION; VOIDING DIFFICULTIES (N=2); BLADDER PERFORATIONS (N=2); ACCIDENTAL PERFORATIONS OF THE VAGINAL WALL BESIDE THE INCISION (N=1); VENOUS BLEEDING OF ABOUT 200 ML (N=1) WHICH WAS SOLVED WITH COMPRESSION; SUBJECTIVE OUTCOME WAS SLIGHTLY IMPROVED (N=5); OVERACTIVE BLADDER/DE NOVO URGENCY WERE MILD (N=2), MODERATE (N=2), UNCHANGED (N=8); POSTOPERATIVE CYSTITIS WITH 1-2 EPISODES (N=5) AND 3-4 EPISODES (N=1). IN CONCLUSION, THE SUBJECTIVE CURE RATE FOR TVT-SECUR WAS SIGNIFICANTLY LOWER THAN FOR TVT. THEREFORE, WE SEE NO RATIONALE IN USING TVT-SECUR AND WE BELIEVE THAT IT IS IMPORTANT TO DISCOURAGE FROM IT FOR FURTHER USE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646379 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention