MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Urinary Frequency (2275); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 09/11/2022

Event Type  Injury  

Event Description

Title: the efficacy and complications of retropubic tension-free vaginal tapes after 20 years: a prospective observational study.This study aimed to assess the very long-term efficacy and safety of the retropubic tvt for the primary treatment of stress urinary incontinence in a single centre.Between 1999 and 2004, 350 women who had a retropubic tension-free vaginal tape procedure for stress urinary incontinence were included in the study.167 patients were lost to follow-up while 183 patients responded to questionnaire.The median age of women at follow up was 67 years (range 53¿93 years) and the median follow up was 20 years (17¿24 years).All patients received gynecare tvt¿ retropubic system (ethicon).Reported complications included urinary tract infection (n=14), voiding difficulty (n=12), urinary retention (n=8), urinary urgency (6 weeks post-op (n=11), occasionally at follow-up (n=77), occurring all the time at follow-up (n=9), nocturia (6 weeks post-op (n=1), at follow-up (n=12), urinary frequency at follow-up (n=132), severe urinary frequency at follow-up (n=11),vaginal pain (n=3), pain requiring resection of tape (n=2), dyspareunia (n=2), mesh erosion (n=2), wound infection (n=6), hematoma (n=1), hernia (n=1), stress urinary incontinence at the time of follow-up (n=111).In conclusion, tension-free vaginal tape has high levels of satisfaction and cure up to 24 years after placement.Pain was uncommon and its impact on quality of life was low.Symptoms of urgency were prevalent but may be related to age.Tvt is an effective treatment for stress urinary incontinence more than 20 years after initial placement.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.An attempt has been 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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned.Citation: bjog.2023;130:107¿113; doi: 10.1111/1471-0528.17282.

• Brand Name: TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18876643
• MDR Text Key: 337347060
• Report Number: 2210968-2024-02819
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female