BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD

    MDR report key: 7947366 · Received October 9, 2018

    Report

    Report Number
    2210968-2018-76415
    Event Type
    Injury
    Date Received
    October 9, 2018
    Report Date
    September 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF FURTHER DETAILS ARE RECEIVED AT THE 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 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 USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J (2014) 25:319¿322; DOI 10.1007/S00192-013-2212-X -(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: URETHROVAGINAL FISTULAE ASSOCIATED WITH TENSION-FREE VAGINAL TAPE PROCEDURES: A CLINICAL CHALLENGE" AUTHOR(S): CHRISTL REISENAUER & JULIAN JANOWITZ & DIETHELM WALLWIENER & MARKUS HUEBNER CITATION: INT UROGYNECOL J (2014) 25:319¿322; DOI 10.1007/S00192-013-2212-X THIS STUDY AIMED TO PRESENT THE SURGICAL REPAIR OF SEVEN URETHROVAGINAL FISTULAE THAT OCCURRED AFTER TENSION-FREE VAGINAL TAPE PROCEDURES AND SUBSEQUENT TREATMENT OF SUI. BETWEEN JUL2007 AND MAR2013, SEVEN PATIENTS WHO UNDERWENT TENSION-FREE VAGINAL TAPE PROCEDURE FOR STRESS URINARY INCONTINENCE DEVELOPED URETHROVAGINAL FISTULAE AND PENETRATION OF THE TENSION-FREE VAGINAL TAPE INTO THE URETHRA. ALL PATIENTS COMPLAINED OF URETHRAL PAIN, REPEATED URINARY INFECTIONS, AND URINE LOSS. VAGINAL EXAMINATIONS REVEALED URETHROVAGINAL FISTULAE. THE TREATMENT OF THE PATIENTS WERE AS FOLLOWS: IN FIRST CASE, A (B)(6) FEMALE PATIENT, WHO INITIALLY UNDERWENT RETROPUBIC TVT (GYNECARE) FOR SUI, WAS TREATED WITH EXCISION OF SUBURETHRAL PART OF THE TAPE AND THE URETHRAL DEFECT CLOSED WITH 3-0 INTERRUPTED POLYGLACTIN SUTURES IN TWO TENSION-FREE LAYERS. AFTER FISTULAE CLOSURE, SHE COMPLAINED ABOUT SUI AND THIS PATIENT HAD ONGOING CONSERVATIVE TREATMENT. IN SECOND CASE, A (B)(6) FEMALE PATIENT, WHO INITIALLY UNDERWENT RETROPUBIC TVT (GYNECARE) FOR SUI, WAS TREATED WITH PARTIAL TVT¿ REMOVAL AND CLOSURE OF URETHRAL WALL AT OTHER HOSPITAL. THIS PATIENT HAD RECURRENT FISTULAE WHICH WAS TREATED BY CLOSING A MARTIUS FLAP. AFTER FISTULAE CLOSURE, SHE COMPLAINED ABOUT SUI AND WAS TREATED CONSERVATIVELY, BUT ADDITIONAL SURGICAL PROCEDURE OF RETROPUBIC TVT WAS PERFORMED AFTER INEFFECTIVE CONSERVATIVE TREATMENT DUE TO LACK OF URETHRAL MOBILITY AND INTRINSIC URETHRAL DEFICIENCY. IN THIRD CASE, A (B)(6) FEMALE PATIENT, WHO INITIALLY UNDERWENT TRANSOBTURATOR INSIDE-OUT (TVT-O) (GYNECARE) FOR SUI, WAS TREATED WITH PARTIAL TVT-O REMOVAL AND CLOSURE OF URETHRAL WALL AT OTHER HOSPITAL. THIS PATIENT HAD RECURRENT FISTULAE WHICH WAS TREATED BY CLOSING A MARTIUS FLAP. AFTER FISTULAE CLOSURE, SHE COMPLAINED ABOUT SUI AND WAS TREATED CONSERVATIVELY, BUT ADDITIONAL SURGICAL PROCEDURE OF RETROPUBIC TVT WAS PERFORMED AFTER INEFFECTIVE CONSERVATIVE TREATMENT DUE TO LACK OF URETHRAL MOBILITY AND INTRINSIC URETHRAL DEFICIENCY. IN FOURTH CASE, A (B)(6) FEMALE PATIENT, WHO INITIALLY UNDERWENT RETROPUBIC TVT (GYNECARE) FOR SUI, WAS TREATED WITH PARTIAL TVT REMOVAL AND CLOSURE OF URETHRAL WALL AT OTHER HOSPITAL. THIS PATIENT HAD RECURRENT FISTULAE WHICH WAS TREATED BY CLOSING A MARTIUS FLAP. AFTER FISTULAE CLOSURE, SHE COMPLAINED ABOUT SUI AND THIS PATIENT HAD ONGOING CONSERVATIVE TREATMENT. IN FIFTH CASE, A (B)(6) FEMALE PATIENT, WHO INITIALLY UNDERWENT RETROPUBIC TVT (GYNECARE) FOR SUI, WAS TREATED WITH PARTIAL TVT REMOVAL AND CLOSURE OF URETHRAL WALL. THIS PATIENT HAD RECURRENT FISTULAE WHICH WAS TREATED BY CLOSING A VAGINAL FLAP SITUATED CLOSE TO THE EXTERNAL URETHRAL MEATUS. POSTOPERATIVELY, THIS PATIENT WAS CONTINENT. IN SIXTH CASE, AN (B)(6) FEMALE PATIENT, WHO INITIALLY UNDERWENT RETROPUBIC TVT (GYNECARE) FOR SUI, WAS TREATED WITH PARTIAL TVT REMOVAL AT OTHER HOSPITAL. ADDITIONALLY, SHE HAD COMPLETE TVT SLING REMOVAL DUE TO PERSISTENT EXTENSIVE INFLAMMATION OF THE ANTERIOR VAGINAL WALL REACHING HIGH INTO THE RETROPUBIC SPACE. DUE TO HER COMPLETELY DESTROYED URETHRA ASSOCIATED WITH SEVERE INCONTINENCE, SHE WAS TREATED WITH ILEAL CONDUIT. POSTOPERATIVELY, SHE WAS CONTINENT. FISTULAE DIAGNOSED YEARS AFTER THE TAPE PROCEDURE MAY BE EXPLAINED BY SLING PENETRATION INTO THE URETHRA OVER THE YEARS. THE CASES REPORTED HERE SHOULD RAISE AWARENESS OF POTENTIAL COMPLICATIONS THAT CAN OCCUR AFTER MIDURETERAL SLING PLACEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787224 TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention