BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7948909 · Received October 9, 2018

    Report

    Report Number
    2210968-2018-76420
    Event Type
    Injury
    Date Received
    October 9, 2018
    Report Date
    September 14, 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

    (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 (2016) 27:247¿253, DOI 10.1007/S00192-015-2820-8, PUBLISHED ONLINE: 30 AUGUST 2015 23298 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: INCONTINENCE SURGERY IN OBESE WOMEN: COMPARATIVE ANALYSIS OF SHORT- AND LONG-TERM OUTCOMES WITH A TRANSOBTURATOR SLING" AUTHORS: INÊS PEREIRA, ALEXANDRE VALENTIM-LOURENÇO, CATARINA CASTRO, INÊS MARTINS, ALEXANDRA HENRIQUES AND ANA LUÍSA RIBEIRINHO CITATION: INT UROGYNECOL J (2016) 27:247¿253, DOI 10.1007/S00192-015-2820-8, PUBLISHED ONLINE: 30 AUGUST 2015. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFECTIVENESS AND SAFETY OF A TRANS-OBTURATOR MID-URETHRAL SLING IN INCONTINENT OBESE WOMEN OVER A 4-YEAR PERIOD. BETWEEN JANUARY 2004 AND JUNE 2012, ALL 281 WOMEN WHO UNDERWENT INCONTINENCE SURGERY USING THE INSIDE-OUT MID-URETHRAL TRANSOBTURATOR SLING TVT-O (GYNECARE TVT¿ OBTURATOR SYSTEM, ETHICON) WERE INCLUDED IN THE STUDY. ACCORDING TO THEIR BODY MASS INDEX (BMI), WOMEN WERE STRATIFIED IN TWO GROUPS¿OBESE (BMI=30 KG/M2) (122 WOMEN; MEAN AGE IN YEARS (SD) = 60.3 (10.1)) AND NON-OBESE (BMI<30 KG/M2) (159 WOMEN; MEAN AGE IN YEARS (SD) = 60.3 (9.6)) ¿USING THE CUTOFF POINTS RECOMMENDED BY THE WORLD HEALTH ORGANIZATION FOR THE WESTERN POPULATION. PERIOPERATIVE COMPLICATIONS INCLUDED: IN THE NON-OBESE GROUP 1 CASE OF EXCESSIVE BLEEDING, 2 VAGINAL PERFORATIONS, 1 CASE OF DE NOVO OVERACTIVE BLADDER (OAB), 2 VAGINAL MUCOSAL EROSIONS AND NO CASES OF URINARY RETENTION OR BLADDER PERFORATION. IN THE OBESE GROUP THERE WAS 1 CASE OF EXCESSIVE BLEEDING, 3 VAGINAL PERFORATIONS, 2 CASES OF DE NOVO OAB, 1 CASE OF URINARY RETENTION, 2 VAGINAL MUCOSAL EROSIONS, AND NO CASES OF BLADDER PERFORATION. WE ALSO REGISTERED A LOW RE-OPERATION RATE, WITH 2.5 % OF WOMEN (3 OUT OF 122) IN THE OBESE GROUP BEING SUBJECTED TO A SECOND RELATED PROCEDURE (1 FOR MESH EROSION, 1 FOR URINARY RETENTION, AND 1 FOR SURGICAL FAILURE) AND 1.3 % (2 OUT OF 159) IN THE NON-OBESE GROUP (BOTH FOR MESH EROSION), P=0.66. IN CONCLUSION, THE TVT-O PROCEDURE IS EFFECTIVE AND SAFE IN THE LONG TERM FOR STRESS INCONTINENCE TREATMENT, REGARDLESS OF BMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789893 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention