BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7912535 · Received September 26, 2018

    Report

    Report Number
    2210968-2018-76064
    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 Location
    BR
    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. 2015; 26: 335¿342. DOI: 10.1007/S00192-014-2501-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MULTICENTER, RANDOMIZED TRIAL COMPARING NATIVE VAGINAL TISSUE REPAIR AND SYNTHETIC MESH REPAIR FOR GENITAL PROLAPSE SURGICAL TREATMENT". AUTHORS: SIMONE DOS REIS BRANDÃO DA SILVEIRA & JORGE MILHEM HADDAD & ZSUZSANNA ILONA KATALIN DE JÁRMY-DI BELLA & FERNANDA NASTRI & MIRIAM GONCALVES MARKOS KAWABATA & SILVIA DA SILVA CARRAMÃO & CLAUDINEI ALVES RODRIGUES & EDMUND CHADA BARACAT & ANTONIO PEDRO FLORES AUGE. CITATION: INT UROGYNECOL J. 2015; 26: 335¿342. DOI: 10.1007/S00192-014-2501-Z. THIS TRIAL AIMED TO COMPARE THE OUTCOMES OF NATIVE VAGINAL TISSUE REPAIR VERSUS POLYPROPYLENE MESH REPAIR FOR THE TREATMENT OF SEVERE GENITAL PROLAPSE. THIS MULTICENTER RANDOMIZED TRIAL INCLUDED 184 WOMEN, WITH POP-Q STAGE 3 OR 4. THEY WERE RANDOMLY ASSIGNED TO UNDERGO SURGICAL TREATMENT USING NATIVE TISSUE REPAIR (N-90; AGE: 64.91 ± 7.48; BMI: 27.84 ± 4.03) OR SYNTHETIC MESH REPAIR (N-94; AGE: 66.31 ± 7.01; BMI: 27.32 ± 4.62). IN THE NATIVE TISSUE REPAIR GROUP, A TVT-O TRANSOBTURATOR MEDIAN URETHRAL SLING (ETHICON) WAS USED AS AN ASSOCIATED PROCEDURE IN 5 PATIENTS. IN THE SYNTHETIC MESH REPAIR GROUP, THE DEVICE USED WAS A PROLIFT TYPE 1 MONOFILAMENT MACROPORE MESH (ETHICON). ALL PATIENTS WITH UTERINE PROLAPSE UNDERWENT HYSTERECTOMY, WITH THE MESH BEING PASSED THROUGH THE HYSTERECTOMY INCISION; NO ¿T¿ INCISIONS WERE MADE. TVT-O TRANSOBTURATOR MEDIAN URETHRAL SLING (ETHICON) WAS USED AS AN ASSOCIATED PROCEDURE IN 9 PATIENTS. IN THE NATIVE TISSUE REPAIR GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER INJURY (N-1), DYSPAREUNIA (N-5), DIFFICULT URINATION (N-3), AND RECURRENCE (N-16) WHICH REQUIRED RE-OPERATION (N-3). IN THE SYNTHETIC MESH REPAIR GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER INJURY (N-3), BOWEL LOOP INJURY (N-1), BLEEDING (N-3) WHICH REQUIRED TRANSFUSION, INFECTION (N-3), DYSPAREUNIA (N-3), DIFFICULT URINATION (N-3), EXTRUSION (N-18) WHICH REQUIRED RE-OPERATION USING VAGINAL AND TRANSRECTAL APPROACHES IN ORDER TO REMOVE ALL THE MESH AND UNDERWENT REPAIR OF THE RECTUM MUCOSA AND APPROXIMATION OF THE LEVATOR-ANI MUSCLE WITH A POLYGALACTIN SUTURE IN 1 PATIENT, MESH EXPOSURE (N-18) WHICH REQUIRED MESH CORRECTION OF THE ANTERIOR COMPARTMENT (N-5), MESH CORRECTION OF THE POSTERIOR COMPARTMENT (N-2), AND ANTERIOR AND POSTERIOR MESH REPAIR (N-11), COMPLETE DEHISCENCE OF THE VAGINAL VAULT SUTURES AND MESH EXPOSURE (N-1) WHICH REQUIRED REVISION SURGERY FOR MESH REMOVAL AND RESUTURING OF THE VAGINAL VAULT, AND THE FOLLOW-UP WAS SATISFACTORY, AND RECURRENCE (N-7) WHICH REQUIRED RE-OPERATION (N-2). THE AUTHORS CONCLUDED THAT BOTH TESTED TECHNIQUES FOR TREATMENT OF SEVERE GENITAL PROLAPSE WERE EFFECTIVE. BOTH TECHNIQUES WERE EFFECTIVE. ANATOMICAL EFFICACY WAS SUPERIOR IN THE MESH GROUP REGARDING THE ANTERIOR COMPARTMENT; QUALITY OF LIFE CHANGES WERE ALSO GREATER IN THE MESH GROUP. COMPLICATIONS WERE SIGNIFICANTLY HIGHER IN THE MESH GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753265 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention