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); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Pain (1994); Blood Loss (2597); 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.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 (tension-free vaginal tape-retropubic and 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: int urogynecol j.2013; 24: 223¿229.Doi: 10.1007/s00192-012-1840-x.(b)(4).

Event Description

It was reported via journal article: "title : one-year results of a prospective randomized, evaluator-blinded, multicenter study comparing tvt and tvt secur" author: maria andrada hamer & per-göran larsson & pia teleman & christina eten bergqvist & jan persson citation: int urogynecol j.2013; 24: 223¿229.Doi: 10.1007/s00192-012-1840-x.The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (tvt) with tvt secur in terms of efficacy and safety.A total of 121 patients with primary stress urinary incontinence (sui) or mixed urinary incontinence (mui) with predominant sui symptoms underwent surgery and were available for follow-up.Of which, 61 patients (age range: 33 to 78 years old; bmi: 18.8 to 36) underwent tvt (tvt group) and 60 patients (age range: 33 to 84 years old; bmi: 20.3 to 42.1) underwent tvt secur procedure (tvt secur group).All patients were operated on an ambulatory basis following the standard techniques for gynecare retropubic tvt (ethicon) and tvt secur (ethicon).Patients were operated on under local anesthesia using carbocaine¿adrenaline and saline solution, combined with sedation with fentanyl and intravenous propofol.In the tvt group, reported complications included venous bleeding (n-1) which was solved with compression, early recurrence of sui (n-1), de novo urge symptoms (n-10), cystitis (n-11), pain (n-3), dyspareunia (n-2), and mesh exposure (n-2).In the tvt secur group, reported complications included bleeding from corona mortis (n-1) which required immediate surgical re-intervention with evacuation of 1-1 retropubic hematoma and vessel ligature, venous bleeding (n-1) which was solved with compression, tape erosion and intense urgency (n-1) which required urethrocystoscopy and a retropubic tvt procedure and the patient was satisfied, recurrent bacteruria and urgency symptoms (n-1) in which the intracystic part of the sling was removed by a combined endoscopic and cystoscopic procedure, worsened sui (n-1), early recurrence of sui (n-4), de novo urge symptoms (n-7), cystitis (n-13), pain (n-2), dyspareunia (n-3), and mesh exposure (n-3).The tvt secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic tvt procedure.Three serious adverse events occurred in the tvt secur group.The authors therefore discourage further use of tvt secur.Traditional retropubic and transobturator approaches are well studied, easy to perform, proven to be safe, and have excellent cure rates.Therefore, the authors believed that suburethral (mini) slings with alternative anchoring techniques should not be introduced to the market without solid evidence ensuring that they bring an actual benefit to the patient.

• 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: 8043498
• MDR Text Key: 126371870
• Report Number: 2210968-2018-76984
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/19/2018

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: 10/19/2018
• Initial Date FDA Received: 11/06/2018
• 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