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 Tract Infection (2120); Abnormal Vaginal Discharge (2123)

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 urogynecol j (2015) 26:1533¿1540; doi 10.1007/s00192-015-2725-6.(b)(4).

Event Description

Title : surgeon-tailored polypropylene mesh as a tension-free vaginal tape-obturator versus original tvt-o for the treatment of female stress urinary incontinence: a long-term comparative study.The objective of the retrospective study was to compare the safety and efficacy of surgeon-tailored polypropylene mesh (stm) through tension-free vaginal tape obturator (tvt-o) versus original tvt-o in the treatment of stress urinary incontinence (sui) aiming to decrease the cost of treatment.From may2007 to jun2010, all women who underwent stm through tvt-o (n=79; mean age sd of 48.16±7.61 years [ranged 31¿65 years]) and original tvt-o (n=66; 45.08±4.94 years [ranged 33¿56] years) were included in the analysis.In the stm group, prolene®, polypropylene mesh was tailored to form str0ip of about 11x1.5 cm which was then sutured polypropylene sutures.The second group of patients was treated with the inside-out transobturator tension-free vaginal tape (tvt-o) (ethicon) original technique.Complications included vaginal discharge (n=4 stm group, n=3 tvt-o group) treated with oral antibiotics, local metronidazole, and local antiseptics; dyspareunia (n=1 stm group, n=1 tvt-o group); uti (n=2 stm group, n=3 tvt-o group); voiding difficulties (n=1 stm group, n=1 tvt-o group), groin pain (n=12 stm group, n=9 tvt-o group) treated with analgesics which disappeared completely within 4 months; and retention of urine (n=3 tvt-o group) for which one case was catheterized for 2 days followed by relief of symptoms.Persistent sui was reported in 2 patients in stm group, and failure was detected in 3 patients in tvt-o group.This cohort study suggests that the 5-year objective and subjective outcomes of patients treated with stm are comparable to those treated with tvt-o.Furthermore, stm is more economical due to our resterilizable modified helical passers and the cheap polypropylene mesh.

• 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: 7935781
• MDR Text Key: 122804119
• Report Number: 2210968-2018-76325
• 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: Other
• 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: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• 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