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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884); Neurological Deficit/Dysfunction (1982); Pain (1994); Urinary Tract Infection (2120); Post Operative Wound Infection (2446)

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, tvt-o) 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, tvt-o) used in this procedure? citation: int urogynecol j.2016; 27: 103¿111.Doi: 10.1007/s00192-015-2798-2 (b)(4).

Event Description

It was reported via journal article: "title: retropubic tension-free vaginal tape and inside-out transobturator tape: a long-term randomized trial" authors: zhibo zhang & lan zhu & tao xu & jinghe lang citation: int urogynecol j.2016; 27: 103¿111.Doi: 10.1007/s00192-015-2798-2 the tension-free vaginal tape (tvt) and inside-out transobturator tape (tvt-o) are first line surgical treatments for stress urinary incontinence (sui).However, there is a lack of information regarding the long-term comparative safety of these procedures.A total of 140 sui patients were randomized to the tvt (n-70; age: 55 ± 12; bmi: 25 ± 3) or tvt-o procedure (n-70; age 51 ± 12; bmi: 25 ± 4) and were interviewed by an independent investigator at the follow-up.During the procedure, gynecare tvt (ethicon) and gynecare tvt-o (ethicon) were used respectively.In the gynecare tvt group, reported complications included wound infection (n-2), retropubic hematoma (n-1), postoperative urinary difficulty (n-7), de novo voiding symptoms (n-12), worsened storage symptoms (n-1), de novo storage symptoms (n-7), recurrent urinary tract infection (n-5), de novo dyspareunia (n-3), pain (n-5), and tape exposure (n-2).In the gynecare tvt-o group, reported complications included postoperative urinary difficulty (n-2), worsened voiding symptoms (n-1), de novo voiding symptoms (n-7), worsened storage symptoms (n-2), de novo storage symptoms (n-6), recurrent urinary tract infection (n-3), worsened dyspareunia (n-2), de novo dyspareunia (n-5), pain (n-5), and tape exposure (n-5) which were treated with conservative local estrogens, antiseptic treatment, and partial sling removal.In 1 patient, conservative treatment failed and another operation was performed to explant the tape.For sui patients with urethral hypermobility, the tvt procedure tended to cause more perioperative complications than tvt-o.However, at postoperative 95 months, no significant difference was found in the proportion of patients with long-term postoperative complications.Long-term complications after mus were high and mainly included de novo lower urinary tract symptoms, but the frequency of complications did not vary significantly between the groups.The cure rates did not vary between the groups.Despite the high incidence of long-term complications, most complications were not consequential, and the patients¿ qol retained significant improvements in the long term.Sexual function was unchanged by either procedure.Equivalence trials should be designed for future studies.

• 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: 8209661
• MDR Text Key: 131895818
• Report Number: 2210968-2019-78112
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K974098
• 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: 12/13/2018

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: 12/13/2018
• Initial Date FDA Received: 01/02/2019
• 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