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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120)

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 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 used in this procedure? citation: plos one 12 (3): e0174628.Doi: https://doi.Org/10.1371/journal.Pone.0174628.(b)(4).

Event Description

It was reported via journal article: title: "quality of life and objective outcome assessment in women with tape division after surgery for stress urinary incontinence." author: daniela ulrich, vesna bjelic-radisic, anna hollein, gerda trutnovsky, karl tamussino,thomas aigmuller.Citation: plos one 12 (3): e0174628.Doi: https://doi.Org/10.1371/journal.Pone.0174628.This retrospective study aimed to evaluate quality of life (qol) and objective outcome after midurethral tape division or excision.Between 1999 and 2014, 622 female patients underwent suburethral tape operations.Of these, 15 patients (mean age sd of 60.20±7.51 years) needed tape division for voiding dysfunction (n=7), overactive bladder (n=2), mesh extrusion (n=3) and ongoing pain (n=3).This cohort were matched to a control group (n=30; mean age sd of 57.43±4.41 years).In the study group, 8 patients received tension-free vaginal tape (tvt) (gynecare), 6 patients received tvt-o (gynecare), and one patient received tvt secur (tvt-s) (gynecare); whereas in the control group, 16 patients received tvt, 12 patients received tvt-o and 2 patients received tvt-s.In the treatment group, the oab symptoms (n=2) did not resolve but there was no recurrent sui; in 3 patients with persistent tape-related pain, the tape was excised up to 15mm to both sides with subsequent pain resolution.One patient had recurrent sui.Ongoing pain or oab were treated conservatively for quite a long time before a repeat surgery was indicated.Upon follow-up, outcome included subjective sui (n=8 treatment group and n=5 control group) of which incontinence were treated with reoperation (tvt, tvt-o and bulkamid), worsened lower urinary tract symptoms (n=4 treatment group and n=5 control group), oab symptoms (n=8 treatment group and n=5 control group), detrusor overactivity (n=2 treatment group), de novo oab (n=4 treatment group and n=8 control group) with one patient in each group who had symptom resolution.Other outcome on questionnaires included leaking during activity, enuresis, leakage during intercourse, infection, painful bladder and voiding difficulties.Additionally of the patients who underwent suburethral tape operations, one patient had intra-urethral erosions and two patients had vaginal erosions which have been cured in the course of tape excision.In conclusion, women after tape division/ excision have lower qol scores compared to controls mostly because of higher subjective sui rates.

• 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: 7966795
• MDR Text Key: 123749871
• Report Number: 2210968-2018-76537
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/20/2018

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: 09/20/2018
• Initial Date FDA Received: 10/15/2018
• 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