MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Response, Decreased (2271)

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.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? does the surgeon believe that ethicon product ( prolift 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 product involved? citation: european journal of obstetrics & gynecology and reproductive biology 172 (2014) 131¿135; doi: http://dx.Doi.Org/10.1016/j.Ejogrb.2013.11.001.(b)(4).

Event Description

It was reported via journal article: "title : cystocele recurrence after anterior colporrhaphy with and without mesh use".Author: vivien wong, ka lai shek a, judith goh b, hannah krause b, andrew martin c, hans peter dietz.Citation: european journal of obstetrics & gynecology and reproductive biology 172 (2014) 131¿135; doi: http://dx.Doi.Org/10.1016/j.Ejogrb.2013.11.001.This retrospective observational study aimed to evaluate the long-term subjective and objective outcomes following anterior colporrhaphy (ac) with and without mesh use; and assess whether the estimated effect of mesh was modified by the presence of major trauma to the levator ani muscle (¿avulsion¿).Of the 332 patients who underwent ac, 100 female patients (mean age of 64.9 years) underwent ac with mesh (between mar2004 and oct2008) and 83 female patients (mean age of 65.3 years) underwent ac without mesh (between jan2002 and dec2005) attended the audit follow-up.In ac with mesh, mesh used was either prolift (n=49) or perigee (n=51).In the follow-up period, recurrent cystocele of =stage 2 was observed in 33 patients in ac with mesh group.At a mean of four years¿ follow-up, mesh augmentation was associated with reduced cystocele recurrence, but this effect was limited to patients with levator avulsion.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• 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: 7838133
• MDR Text Key: 118962558
• Report Number: 2210968-2018-75566
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013718
• 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: 08/15/2018

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: 08/15/2018
• Initial Date FDA Received: 08/31/2018
• 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