BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD

    MDR report key: 8209108 · Received January 2, 2019

    Report

    Report Number
    2210968-2019-78107
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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: 33¿40. DOI: 10.1007/S00192-013-2150-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "PELVIC ORGAN PROLAPSE SURGERY WITH AND WITHOUT TENSION-FREE VAGINAL TAPE IN WOMEN WITH OCCULT OR ASYMPTOMATIC URODYNAMIC STRESS INCONTINENCE: A RANDOMISED CONTROLLED TRIAL." AUTHORS: LORE SCHIERLITZ, PETER L. DWYER, ANNA ROSAMILIA, ALISON DE SOUZA, CHRISTINE MURRAY, ELIZABETH THOMAS, RICHARD HISCOCK, CHAHIN ACHTARI. CITATION: INT UROGYNECOL J. 2014; 25: 33¿40. DOI: 10.1007/S00192-013-2150-7. THE AUTHORS SET OUT TO DETERMINE IF INSERTION OF A RETROPUBIC TENSION-FREE VAGINAL TAPE (TVT) SLING AT THE TIME OF PELVIC ORGAN PROLAPSE SURGERY IMPROVES CONTINENCE OUTCOMES IN WOMEN WITH PRE-OPERATIVE OCCULT STRESS INCONTINENCE (OSI) OR ASYMPTOMATIC URODYNAMIC STRESS INCONTINENCE (USI). THE AUTHORS CONDUCTED A RANDOMIZED CONTROLLED STUDY OF PROLAPSE SURGERY WITH OR WITHOUT A TVT MIDURETHRAL SLING. A TOTAL OF 80 WOMEN RECEIVED PROLAPSE SURGERY. OF WHICH, 43 PATIENTS (AGE: 66 YEARS; BMI: 27) RECEIVED PROLAPSE SURGERY ALONE AND 37 PATIENTS (AGE: 67 YEARS; BMI: 26) WITH CONCURRENT TVT. DURING THE SURGICAL PROCEDURE IN THE TVT GROUP, GYNECARE TVT (ETHICON) WAS USED AS DESCRIBED. IN THE TVT GROUP, REPORTED COMPLICATIONS INCLUDED HEMORRHAGE (N-1), VOIDING DIFFICULTY (N-4), URODYNAMIC STRESS INCONTINENCE (N-4), DE NOVO URGENCY AT 6 MONTHS POSTOPERATIVELY (N-5), AND DE NOVO URGENCY AT 24 MONTHS POSTOPERATIVELY (N-5). THE LOW NUMBER OF SLING PROCEDURES REQUIRED IN THE NONINTERVENTION GROUP TO CORRECT SYMPTOMATIC STRESS URINARY INCONTINENCE AFTER MORE THAN 24 MONTHS¿ FOLLOW-UP SUPPORTS THE VIEW THAT ROUTINE INSERTION OF A SLING IN WOMEN WITH OSI AT THE TIME OF PROLAPSE REPAIR IS QUESTIONABLE AND SHOULD BE SUBJECT TO SHARED DECISION-MAKING. WOMEN SHOULD BE CAREFULLY COUNSELLED REGARDING THE POSSIBILITY OF SUI OCCURRING POSTOPERATIVELY AND THE RISKS AS WELL AS THE BENEFITS OF CONCOMITANT SLING SURGERY. THESE FINDINGS ALSO HAVE IMPLICATIONS FOR THE ROUTINE USE OF URODYNAMIC ASSESSMENT IN THE DETECTION OF OSI AND WOULD SUGGEST THAT THEY MIGHT NOT BE WARRANTED FOR THIS PURPOSE IN THE PATIENT ASYMPTOMATIC FOR SUI PRIOR TO PROLAPSE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591 TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention