BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 12452751 · Received September 10, 2021

    Report

    Report Number
    2210968-2021-08272
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    May 20, 2020
    Report Date
    August 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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:J. CLIN. MED. 2020, 9, 1538; DOI:10.3390/JCM9051538. 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 VAGINAL TAPE) 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

    TITLE: IMPACT OF MIDURETHRAL SLING IMPLANTATION ON SEXUAL FUNCTION IN WOMEN WITH STRESS URINARY INCONTINENCE. THE PRIMARY OBJECTIVE OF THE STUDY WAS TO EVALUATE THE INFLUENCE OF THE SUCCESSFUL TVT (TENSION-FEE VAGINAL TAPE) PROCEDURE ON DIFFERENT ASPECTS OF SEXUAL LIFE. THE SECOND OBJECTIVE WAS TO ANALYZE VARIOUS ASPECTS OF SEXUAL LIFE IN CASES IN WHOM FAILURE OF THE ANTI-INCONTINENCE PROCEDURE WAS DIAGNOSED. THE PRESENT STUDY WAS PERFORMED DURING THE YEARS 2018¿2020 AS A PROSPECTIVE COHORT STUDY. 171 PATIENTS UNDERGOING THE MUS PROCEDURE. THE INCLUSION CRITERIA COMPRISED SUI AND CONSENT FOR SURGERY. ALL PATIENTS HAD THE RETROPUBIC SLING IMPLANTED (GYNECARE TVT BLUE, ETHICON INC., JOHNSON & JOHNSON, SOMERVILLE, NJ, USA). THE SURGICAL PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, ACCORDING TO THE 1/3 RULE, AFTER PELVIC FLOOR ULTRASOUND EXAMINATION OF URETHRAL LENGTH (THE LOCATION OF THE DISTAL END OF THE VAGINAL INCISION FROM THE EXTERNAL URETHRAL ORIFICE EQUALED ONE THIRD OF THE SONOGRAPHIC URETHRAL LENGTH). IN ALL CASES, TENSIONING OF THE TAPE WAS ACHIEVED WITH THE USE OF INTRAOPERATIVE COUGH TEST. REPORTED COMPLICATION INCLUDED URINE RETENTION AND VOIDING DIFFICULTIES (N=4), SURGICAL FAILURE (N=12), URGENCY(N=4), URINARY RETENTION (N=3), PERSISTENT SUI(N=8), MIXED UI (N=4), DYSPAREUNIA. IN CONCLUSION OUTCOMES SUGGEST THAT SUCCESSFUL TREATMENT OF SUI WITH THE MIDURETHRAL SLING STATISTICALLY SIGNIFICANTLY IMPROVES THE QUALITY OF SEXUAL LIFE. TREATMENT FAILURE, RESULTING IN PERSISTENT INCONTINENCE OR COMPLICATIONS SUCH AS OAB WITH URGENCY, APPEARS TO BE A PROBABLE CAUSE OF LACK OF IMPROVEMENT IN THE QUALITY OF SEXUAL LIFE. FURTHER ANALYSIS OF FAILED CASES IS NEEDED TO CONFIRM THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352593 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention