BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 12454400 · Received September 10, 2021

    Report

    Report Number
    2210968-2021-08298
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    March 12, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: HTTPS://DOI.ORG/10.1016/J.UROLOGY.2020.04.073. 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 THE ETHICON PRODUCT (TENSION FREE VAGINAL TAPE OBTURATOR) 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? PATIENT DEMOGRAPHICS?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: EVALUATION OF EFFICACY AND SAFETY OF SINGLE-INCISION SLING VERSUS TRANSOBTURATOR SLING IN WOMEN WITH STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY. THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF SINGLE-INCISION SLINGS (SISS) VERSUS TRANSOBTURATOR SLINGS (TOSS) IN SUCH PATIENTS. A TOTAL OF 109 PATIENTS (N=37 SIS, N=72 TOS) WHO HAD STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY (ISD) WHO UNDERWENT SIS OR TOS PROCEDURES BETWEEN JANUARY 2010 TO DECEMBER 2017 WERE INCLUDED. THE TOSS USED INCLUDED TVT-O® (ETHICON INC., JOHNSON & JOHNSON, SOMERVILLE, NJ, USA), MONARC® (AMERICAN MEDICAL SYSTEMS, MINNETONKA, MN, USA), AND OBTRYX® (BOSTON SCIENTIFIC CORP; NATICK, MA,USA). ALL OF THE SURGICAL PROCEDURES WERE PERFORMED BY TWO EXPERIENCED SURGEONS. URODYNAMIC MEASUREMENTS AND QUALITY OF LIFE EVALUATIONS WERE CONDUCTED BY TWO TECHNICIANS. THE OBJECTIVE AND SUBJECTIVE CURE RATES AND SURGICAL ADVERSE EVENTS WERE COMPARED BETWEEN DIFFERENT SLINGS. THE MEDIAN FOLLOW-UP TIME WAS 21 MONTHS (RANGE 12¿72 MONTHS) IN THE SIS GROUP AND 24 MONTHS (RANGE 14¿84 MONTHS) IN THE TOS GROUP (P = 0.317). BOTH THE SIS AND TOS GROUPS HAD SIGNIFICANT IMPROVEMENTS IN THE 1-H PAD TEST, INCONTINENCE-RELATED QUALITY OF LIFE, AND SYMPTOM DISTRESS POSTOPERATIVELY, INDICATING THAT BOTH SURGICAL PROCEDURES WERE EFFECTIVE IN THE TREATMENT OF SUI AND ISD. THERE WERE NO SIGNIFICANT DIFFERENCES IN OTHER FACTORS BETWEEN THE TWO GROUPS, AND NEITHER GROUP HAD LONG TERM ADVERSE EFFECTS OR MESH EXTRUSION. THE SUBJECTIVE CURE RATE WAS 78% IN THE SIS GROUP AND 83% IN THE TOS GROUP, WITH THE SAME OBJECTIVE CURE RATES OF 76% IN BOTH GROUPS. THERE WERE NO SIGNIFICANT DIFFERENCES IN ADVERSE EVENTS, EXCEPT SISS HAD A SHORTER SURGERY TIME (16.4 ± 9.3 VS. 27.3 ± 12.4 MIN, P = 0.020) AND LOWER POSTOPERATIVE VISUAL ANALOG SCALE PAIN SCORE (1.3 ± 1.1 VS. 3.9 ± 1.4, P < 0.001). ALTHOUGH THE SUBJECTIVE CURE RATE WAS SLIGHTLY LOWER IN THE SIS GROUP, THE RATE OF REPEAT SLING SURGERIES FOR RECURRENT SUI WAS COMPARABLE IN THE TWO GROUPS. REPORTED POSTOPERATIVE COMPLICATIONS IN THE TOS GROUP INCLUDED N=? PAIN (VAS PAIN SCORE OF 3.9±1.4), N=? BLOOD LOSS, N=5 URINE RETENTION, N=3 TEMPORARY URINARY TRACT INFECTION, N=3 DE NOVO OAB AND N=5 RECURRENT SUI. IN CONCLUSION, SISS AND TOSS HAD SIMILAR SURGICAL RESULTS IN WOMEN WITH STRESS INCONTINENCE AND ISD AFTER AT LEAST 1 YEAR OF FOLLOWUP. HOWEVER, SISS HAD A SHORTER OPERATION TIME AND LOWER POSTOPERATIVE PAIN THAN TOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351701 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention