MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Impaired Healing (2378); 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Attempts are being made to obtain the additional information. To date no response has been provided. 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 products (tension free vaginal tape - obturator and prolene polypropylene mesh ) 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 involved? citation: int urol nephrol (2015) 47:937¿944; doi 10. 1007/s11255-015-0974-4 please see referenced article attached. (b)(4).

Event Description

It was reported in a journal article title : surgeon-tailored polypropylene mesh as a needleless single-incision sling versus tvt-o for the treatment of female stress urinary incontinence: a comparative study this retrospective cohort study aimed to compare safety and efficacy of surgeon-tailored polypropylene mesh through needleless single incision technique (stm) versus tension-free vaginal tape obturator (tvt-o) aiming to decrease cost of treatment of stress urinary incontinence (sui). From jan2011 to aug2013, all women who underwent stm technique (n
=
72; median age of 43[33-67] years) and tvt-o (n
=
48; median age of 45 [33-56] years) for the treatment of sui were included in the analysis. In stm group, the mesh used was a prolene polypropylene mesh which was surgeon tailored to give a strip of 15x2. 5cm which was inserted through a needleless single incision technique. In tvt-o group, the patients were treated with the original inside out transobturator tension-free vaginal tape technique (tvt-o; ethicon). Complications included vaginal discharge (n
=
6 stm group; n
=
3 tvt-o group), dyspareunia (n
=
3 stm group; n
=
1 tvt-o group), urinary tract infection (n
=
5 stm group; n
=
3 tvt-o group), voiding difficulties (n
=
2 stm group; n
=
1 tvt-o group) for which they were catheterized for few days followed by the relief of symptoms, groin pain (n
=
4 tvt-o group) treated with analgesics within one month, retention of urine (n
=
1 stm group; n
=
1 tvt-o group) treated with catheterization for few days by the relief of symptoms and failure of wound healing (n
=
1 stm group) which did not heal after local estrogen application; treated with control of infection and wound was closed in two layers after trimming of edges. Failure of treatment (persistent sui) was detected in stm group (n
=
1) and tvt-o group (n
=
2). Though no intraoperative injury was detected, the single incision technique reduces the potential risk of transobturator technique of nerve or vascular damage due to the passage of needles. Outcome of stm is comparable to tvt-o. Furthermore, stm is more economic.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7932128
• MDR Text Key: 122629308
• Report Number: 2210968-2018-76300
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/03/2018 Patient Sequence Number: 1