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

Device Problem Use of Device Problem (1670)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/20/2020

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.Citation:j.Clin.Med.2020, 9, 1538; doi:10.3390/jcm9051538.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 vaginal tape) 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

Title: impact of midurethral sling implantation on sexual function in women with stress urinary incontinence.The primary objective of the study was to evaluate the influence of the successful tvt (tension-fee vaginal tape) procedure on different aspects of sexual life.The second objective was to analyze various aspects of sexual life in cases in whom failure of the anti-incontinence procedure was diagnosed.The present study was performed during the years 2018¿2020 as a prospective cohort study.171 patients undergoing the mus procedure.The inclusion criteria comprised sui and consent for surgery.All patients had the retropubic sling implanted (gynecare tvt blue, ethicon inc., johnson & johnson, somerville, nj, usa).The surgical procedure was performed under general anesthesia, according to the 1/3 rule, after pelvic floor ultrasound examination of urethral length (the location of the distal end of the vaginal incision from the external urethral orifice equaled one third of the sonographic urethral length).In all cases, tensioning of the tape was achieved with the use of intraoperative cough test.Reported complication included urine retention and voiding difficulties (n=4), surgical failure (n=12), urgency(n=4), urinary retention (n=3), persistent sui(n=8), mixed ui (n=4), dyspareunia.In conclusion outcomes suggest that successful treatment of sui with the midurethral sling statistically significantly improves the quality of sexual life.Treatment failure, resulting in persistent incontinence or complications such as oab with urgency, appears to be a probable cause of lack of improvement in the quality of sexual life.Further analysis of failed cases is needed to confirm these findings.

• Brand Name: TENSION FREE VAGINAL TAPE 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: 12452751
• MDR Text Key: 270791512
• Report Number: 2210968-2021-08272
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/12/2021

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: 08/12/2021
• Initial Date FDA Received: 09/10/2021
• 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