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

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Therapeutic Response, Decreased (2271)

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.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 (tvt-obturator, tvt-secur) 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 (tvt-obturator, tvt-secur) used in this procedure? citation: menopause: the journal of the north american menopause society vol.21, no.6, pp.641/645; doi: 10.1097/gme.0000000000000119.(b)(4).

Event Description

It was reported via journal article: ¿title: outcome and sexual function after transobturator tape procedure versus tension-free vaginal tape secur: a randomized controlled trial¿.Author(s): xiang tang, phd, md, lan zhu, md, shuo liang, md, and jinghe lang, md.Citation: menopause: the journal of the north american menopause society vol.21, no.6, pp.641/645; doi: 10.1097/gme.0000000000000119.This randomized, non-blinded prospective study aimed to compare the efficacy, safety, and sexual function between inside-out transobturator tape (tvt-o) and tension-free vaginal tape secur (tvt-s) procedures for stress urinary incontinence (sui) treatment.From oct2008 to oct2010, 81 female patients with demonstrable sui who underwent either tvt-o (mean age sd of 51.3 years [7.5 years]) or tvt-s (mean age of 49.8 years [10.1 years]) were included in the analysis.In both procedures, the needles and woven polypropylene tapes were gynecare products (ethicon inc).The tvt-o and tvt-s procedures were performed according to the manufacturer¿s instructions.Postoperatively, complications included hematoma (n=2 tvt-o) which none required blood transfusion or surgical intervention, urinary retention (n=1 tvt-o and n=1 tvt-s), de novo urinary urgency (n=2 tvt-o and n=2 tvt-s), tape erosion (n=3 tvt-o and n=1 tvt-s), groin/thigh pain (n=8 tvt-o and n=1 tvt-s) which none required analgesics drugs, and dyspareunia (n=3 tvt-o and n=1 tvt-s).In a 24-month follow-up, failure was recorded in 5 patients from tvt-o group and 6 patients from tvt-s group.The cause of this pain is unclear but may be related to damage to the posterior division of the obturator nerve or adductor muscles.The tvt-o and tvt-s procedures are effective in chinese women with sui across 2 years of follow-up.The operative time is shorter, and the rate of postoperative groin/thigh pain is lower for patients undergoing the tvt-s procedure.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR 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: 8226407
• MDR Text Key: 132369741
• Report Number: 2210968-2019-78261
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention