BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7911425 · Received September 26, 2018

    Report

    Report Number
    2210968-2018-76047
    Event Type
    Injury
    Date Received
    September 26, 2018
    Report Date
    August 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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 (PROLFIT, PDS SUTURE, TVT-O) 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 (PROLFIT, PDS SUTURE, TVT-O) USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J (2015) 26:1013¿1020; DOI 10.1007/S00192-015-2630-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: "MEDIUM-TERM COMPARISON OF UTERUS PRESERVATION VERSUS HYSTERECTOMY IN PELVIC ORGAN PROLAPSE TREATMENT WITH PROLIFT¿ MESH." AUTHOR(S): LI-YI HUANG & LI-CHING CHU & HSIN-JU CHIANG & FEI-CHI CHUANG & FU-TSAI KUNG & KUAN-HUI HUANG. CITATION: INT UROGYNECOL J (2015) 26:1013¿1020; DOI 10.1007/S00192-015-2630-Z. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE MEDIUM-TERM CLINICAL OUTCOMES AND COMPLICATIONS AFTER TRANSVAGINAL MESH (TVM) REPAIR USING THE TOTAL PROLIFT MESH SYSTEM, AND TO IDENTIFY WHETHER CONCOMITANT HYSTERECTOMY OR UTERUS PRESERVATION HAD DISTINCT CLINICAL INFLUENCES ON THE OUTCOME OF PELVIC RECONSTRUCTION IN PATIENTS WITH NO PREVIOUS HISTORY OF UROGENITAL SURGERY. FROM MAY2007 TO JUL2010, 102 FEMALE PATIENTS WITH POPQ STAGE 3/4 UTERINE PROLAPSE UNDERWENT PELVIC ORGAN PROLAPSE REPAIR WITH PROLIFT MESH (PROLIFT GYNECARE SYSTEM) FOR WHICH CONCOMITANT HYSTERECTOMY (HYSTERECTOMY GROUP; N=24; MEAN AGE SD OF 62.0±10.2 YEARS) AND UTERUS-SPARING SURGERY (UTERUS-SPARING GROUP; N=78; MEAN AGE OF 67.1±9.1 YEARS) WERE PERFORMED. ADDITIONALLY, IN THE UTERUS-SPARING GROUP, TOTAL PROLIFT MESH WAS ATTACHED USING 2/0 PDS SUTURES; VAGINAL MUCOSA WAS CLOSED USING 2/0 VICRYL SUTURES. POSTOPERATIVE ADVERSE EVENTS INCLUDED MESH EXPOSURE (N=5 HYSTERECTOMY GROUP, N=6 UTERUS-SPARING GROUP) WHICH REQUIRED REVISION OF SURGERY (N=3 HYSTERECTOMY GROUP, N=2 UTERUS-SPARING GROUP) AND VAGINAL RE-EPITHELIALIZATION WAS SUCCESSFUL AFTER LOCAL APPLICATION OF ESTROGEN FOR A MINIMUM OF 2 MONTHS (OTHER SIX PATIENTS), RECURRENT PROLAPSE (N=1 HYSTERECTOMY GROUP, N=4 UTERUS-SPARING GROUP) WHICH REQUIRED REOPERATION (N=4 UTERUS-SPARING GROUP), URGENCY (N=4 HYSTERECTOMY GROUP, N=9 UTERUS-SPARING GROUP), DE NOVO STRESS INCONTINENCE (N=1 HYSTERECTOMY GROUP, N=7 UTERUS-SPARING GROUP), UTERINE RETENTION (N=4 UTERUS-SPARING GROUP), POST-VOIDING DRIBBLING (N=1 UTERUS-SPARING GROUP), CONSTIPATION (N=2 HYSTERECTOMY GROUP, N=11 UTERUS-SPARING GROUP), FECAL INCONTINENCE (N=1 HYSTERECTOMY GROUP), DYSPAREUNIA (N=1 UTERUS-SPARING GROUP), VAGINAL PAIN (N=2 UTERUS-SPARING GROUP) AND VAGINAL INFECTION (N=2 HYSTERECTOMY GROUP). DAMAGE TO THE VAGINAL TISSUE, SUCH AS HEMATOMA OR INFECTION, MIGHT IMPEDE THE HEALING OF THE VAGINAL MUCOSA AND CAUSE MESH EXPOSURE WITHIN THE FIRST YEAR AFTER SURGERY. IN CONTRAST, DELAYED MESH EXPOSURE MIGHT BE DUE TO CHRONIC EROSION OF THE MUCOSAL TISSUE UNDER PROLONGED MECHANICAL STRESS, AND TO POOR INTERACTION OF THE GRAFT WITH THE SURROUNDING TISSUE. PELVIC RECONSTRUCTION USING PROLIFT WITH CONCOMITANT HYSTERECTOMY AND UTERUS-SPARING SURGERY HAVE SIMILAR ANATOMIC AND FUNCTIONAL RESULTS AT 2.5 YEARS. THEREFORE, WE CONSIDER UTERUS-SPARING SURGERY TO BE AN ALTERNATIVE TO HYSTERECTOMY IN UTERINE PROLAPSE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753950 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention