BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 8219066 · Received January 4, 2019

    Report

    Report Number
    2210968-2019-78191
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NO, THE CASES WERE NOT REPORTED TO ETHICON. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (TVT-ABBREVO) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? -THE VOIDING PROBLEMS AND THE DE NOVO URGENCY ARE COMPLICATIONS OBSERVED FOLLOWING ANY SUB-URETHRAL SLING POSITIONING, TVT-ABBREVO INCLUDED. UTIS ARE A COMMON POST-OPERATIVE COMPLICATION AND DO NOT SEEM TO BE PARTICULARLY RELATED TO TVT-ABBREVO. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (TVT-ABBREVO) USED IN THIS PROCEDURE? NO, WE DO NOT BELIEVE THAT TVT-ABBREVO HAD ANY DEFICIENCY.

    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 (TVT-ABBREVO) 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 (TVT-ABBREVO) USED IN THIS PROCEDURE? CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 197 (2016) 116¿119; HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2015.11.014 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EFFICACY AND SAFETY OF THE TRANS-OBTURATOR TVT-ABBREVO DEVICE IN NORMAL WEIGHT COMPARED TO OVERWEIGHT PATIENTS AFFECTED BY STRESS URINARY INCONTINENCE" AUTHORS: GIOVANNI A. TOMMASELLI, VALERIO NAPOLITANO, COSTANTINO DI CARLO, CARMEN FORMISANO, ANNAMARIA FABOZZI, AND CARMINE NAPPI CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 197 (2016) 116¿119; HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2015.11.014. THE AIM OF THIS CURRENT RETROSPECTIVE STUDY WAS TO INVESTIGATE IF TVT-ABBREVO HAS SIMILAR OUTCOMES IN NORMAL WEIGHT AND OVERWEIGHT PATIENTS. BETWEEN SEPTEMBER 2011 TO MARCH 2014, 205 PATIENTS WERE INCLUDED IN THE STUDY. THEY WERE STRATIFIED INTO TWO GROUPS BASED ON BODY MASS INDEX (BMI) ACCORDING TO THE WHO DEFINITION OF OVERWEIGHT AND OBESITY: WOMEN WITH A BMI < 25 KG/M2 (NORMAL WEIGHT GROUP, N = 105, AGE RANGE: 55.9 +/- 6.4 YEARS) AND WOMEN WITH A BMI > OR = 25 KG/M2 (OVERWEIGHT GROUP, N = 100, AGE RANGE: 58.5 +/- 7.6 YEARS). ALL PROCEDURES WERE PERFORMED BY TWO INVESTIGATORS ((B)(6)) WHO HAD ALREADY PERFORMED MORE THAN 10 TVT ABBREVO PROCEDURES BEFORE THE PERIOD CONSIDERED FOR THE STUDY. THE TVT-ABBREVO PROCEDURE WAS PERFORMED AS PREVIOUSLY DESCRIBED. DURING THE PROCEDURE, BONE CONTACT WAS MAINTAINED AT ALL TIMES DURING INSERTION, ENSURING A TIGHT PASSAGE AROUND THE BONY STRUCTURE, WITH THE TIP OF THE PASSER EXITING AT THE SKIN LEVEL 0.5¿1 CM LATERALLY OF THE CRURAL PLICAE, MORE MEDIAL THAN THE EXIT POINTS DESCRIBED FOR THE TRADITIONAL TVT-O TECHNIQUE. POSTOPERATIVE COMPLICATIONS WERE 5 POST-OPERATIVE VOIDING PROBLEMS (NORMAL WEIGHT GROUP: 2, OVERWEIGHT GROUP: 3), AND 6 UTIS (NORMAL WEIGHT GROUP: 2; OVERWEIGHT GROUP: 4). EIGHT PATIENTS (NORMAL WEIGHT GROUP: 3 AND OVERWEIGHT GROUP: 5) COMPLAINED ABOUT DE NOVO URGENCY. THESE WOMEN WERE SUCCESSFULLY TREATED WITH ANTICHOLINERGIC DRUGS. NO VAGINAL EROSION WAS OBSERVED IN BOTH GROUPS. IN CONCLUSION, THE MODIFIED AND SHORTENED INSIDE-OUT TRANSOBTURATOR ABBREVO SEEMS TO HAVE SIMILAR EFFICACY AND SAFETY IN NORMAL WEIGHT AND OVERWEIGHT WOMEN. MORE STUDIES ARE NEEDED TO ASSESS THE EFFICACY OF THIS DEVICE IN FRANKLY OBESE WOMEN AS WELL AS LONG-TERM EFFICACY AND SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9019 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention