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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Cyst(s) (1800); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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.Citation: journal of gynecologic surgery volume 37, number 3, 2021.Mary ann liebert, inc.Doi: 10.1089/gyn.2020.0153.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 the ethicon product (tension free vaginal tape - exact) 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 product involved? patient demographics?.

Event Description

It was reported in a journal article with title: outcomes of retropubic sub-mid-urethral sling procedure for recurrent stress urinary incontinence after primary surgical failure in women.This study aims to evaluate the retropubic sub-mid-urethral sling (smus) procedure as an optimal option for treating recurrent stress urinary incontinence (sui) after the failure of a variety of previous operations.Between july 2012 and january 2016, 40 patients underwent the retropubic sub-mid-urethral sling (smus) procedure at the galilee medical center as a secondary surgery for failure after previous incontinence.Surgery were included in the study.All 40 patients underwent sub-mid-urethral sling (smus) using a retropubic sling, gynecare tvt exact continence system (ethicon, usa).Reported complication included: (n=3) had significant stress urinary incontinence (sui).1-month follow-up postoperative: (n=3) significant bladder overactivity symptoms, (n=1) small protrusion of the tape, (n=2) slow urine stream.(n=1) pain in the operating area.3-months follow-up postoperative : (n=9) significant bladder overactivity symptoms, (n=4)slow urine stream , enuresis (n=1) , and(n=1) uti.1-year follow-up postoperative: (n=4) pain, (n=1) pain location: pelvis thighs, (n=2) recurrent uti, (n=1) interstitial cystitis and (n=2) significant bladder overactivity.(n=1) needed urinary catheter placement for 24 hours after surgery because of bladder outlet obstruction.It was concluded, that based on the results of our study, we conclude that retropubic smus procedure performed by trained surgeons for appropriate indications produce favorable outcomes that are comparable with those after most primary surgeries.Therefore, it should be considered in choosing a treatment plan for patients with recurrent sui.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• 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
• MDR Report Key: 14265928
• MDR Text Key: 290527262
• Report Number: 2210968-2022-03183
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2022

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: 04/01/2022
• Initial Date FDA Received: 05/03/2022
• 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
• Patient Sex: Female