MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Granuloma (1876); Hematoma (1884); Hernia (2240); Urinary Frequency (2275); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Web address: doi: 10.1016/j.Eururo.2007.04.060.Citation: european urology 52 (2007): 1481¿1491.(b)(4).

Event Description

Title: tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of multicentre randomised trial.This prospective, multicenter, randomised study aimed to assess complications and functional outcome of tension-free vaginal tape (tvt) and transobturator tape (tot) procedures (primary end points) and the success rate (secondary end point) in women with stress urinary incontinence after a median follow-up of 31 months.From may2002 to nov 2005, 148 female patients with sui or mixed incontinence underwent midurethral sling procedure and were randomised to either tvt (n=73; mean age ± sd of 61.8±10.7 years) or tot (n=75; mean age ± sd of 60.6±10 years).In tvt group, standard operative techniques were the ulmsten (tvt, gynecare, ethicon) and delorme techniques.In the tvt group, complications included bladder injury (n=1); retropubic haematoma (n=1); transient voiding dysfunction (n=3) which required clean intermittent self-catheterism and in one of these three patients, a suprapubic catheter was inserted due to inability to perform self-cathetherism; urethrolysis (n=1); intractable pain caused by foreign body granuloma (n=1) requiring removal of suprapubic edge of the tvt arm; and suprapubic paraincisional hernia at the edge of the tvt (n=1).At a median follow-up of 33 months in tvt group, outcomes included de novo voiding symptoms (n=5), worsening storage symptoms (n=2) and de novo storage symptoms (n=5).Bladder injury is a main concern with the use of retropubic route (tvt) and is not always recognised during initial cystoscopy and can become the source of late complications such as chronic pain and urinary tract infections requiring further surgery.De novo urinary symptoms is linked to changes in paraurethral collagen metabolism and sclerosis around the prolene tape.The main issue with both techniques remains postoperative symptoms, whose underlying mechanism still needs in-depth investigations.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7971756
• MDR Text Key: 123945912
• Report Number: 2210968-2018-76592
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention