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

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Fever (1858); Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Obstruction/Occlusion (2422); Not Applicable (3189)

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.If further details are received at the 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 product (tension free vaginal tape ¿ obturator and tension free vaginal tape ¿ 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 product involved? citation: rjpbcs.2015; 6(1): 1902 (b)(4).

Event Description

It was reported via journal article "title: a comparative analysis of different types of sling system for the treatment of female stress urinary incontinence" authors: zyaka asaf ogly dovlatov, alexander vasilyevich seregin, and oleg borisovich loran citation: rjpbcs.2015; 6(1): 1902.The objective of the study was to compare comparison of the long-term results of using different options sling systems for the treatment of female stress urinary incontinence (sui).The study included 698 women aged 42 to 68 years old with sui (bmi: 23.6 to 30.3).The authors used 4 types of sling: tvt in 167 women, gynecare tvt-o (ethicon) in 359 women, tvt-o in 105 women, and tvt-secur mini-sling system (ethicon) in 67 women.In the gynecare tvt-o group, reported complications included perforation of the bladder (n-3), perforation of the vagina (n-1), retropubic or perineal hematoma (n-3), wound infection (n-1), post-operative fever and urinary tract infection (n-6), hematuria (n-3), irritative and obstructive symptoms without acute urinary retention (n-5), acute urinary retention (n-2), presence of urinary incontinence (n-24), tape protrusion into the vagina (n-2), bladder outlet obstruction, which required tape dissection (n-2), recurrence of stress urinary incontinence (n-12), de novo imperative incontinence (n-4), de novo overactive bladder (n-4), dyspareunia (n-5), and chronic pelvic pain syndrome (n-3).In the tvt-secur mini sling system group, reported complications included perforation of the vagina (n-1), retropubic or perineal hematoma (n-1), post-operative fever and urinary tract infection (n-2), irritative and obstructive symptoms without acute urinary retention (n-1), presence of urinary incontinence (n-5), tape protrusion into the vagina (n-1), recurrence of stress urinary incontinence (n-2), de novo overactive bladder (n-1), dyspareunia (n-1), and chronic pelvic pain syndrome (n-1).The effectiveness of surgical treatment of stress urinary incontinence using the sling systems can achieve more than 90% irrespective of the type sling procedure.This efficacy of the treatment, as well as high safety and low morbidity are the main advantages of sling procedures prior to the classical approach to the surgical treatment of urinary incontinence.The study showed that compared sling techniques had no significant differences in objective and subjective criteria for the effectiveness of treatment.

• 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: 7970901
• MDR Text Key: 123940025
• Report Number: 2210968-2018-76581
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2018

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: 09/24/2018
• 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