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); Pain (1994); 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.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 products (prolift mesh, gynecare mesh, tvt secur, tvt unknown and tvt obturator) 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: am j obstet gynecol 2016;215:206.E1-8; doi: http://dx.Doi.Org/10.1016/j.Ajog.2016.04.008.(b)(4).

Event Description

It was reported via journal article: "title: host response to synthetic mesh in women with mesh complications" authors: alexis l.Nolfi, bs; bryan n.Brown, phd; rui liang, md; stacy l.Palcsey, bs; michael j.Bonidie, md; steven d.Abramowitch, phd; pamela a.Moalli, md, phd.Citation: am j obstet gynecol 2016;215:206.E1-8; doi: http://dx.Doi.Org/10.1016/j.Ajog.2016.04.008.The purpose of this study was to define and compare the macrophage response in patients who undergo mesh excision surgery for the indication of pain vs a mesh exposure.Patients who were scheduled to undergo surgical excision of mesh for pain or exposure were included in the study.A total of 27 female patients underwent excision of mesh due to primary complaint of exposure (n=15) and pain without exposure (n=12).Four of the 27 patients mesh were implanted via abdominal sacrocolpexy and the rest were inserted transvaginally.For the type of mesh excised, mesh included gynecare prolift mesh kit (n=2), gynecare gynemesh ps (n=4), gynecare tvt secur (n=3), gynecare tvt (n=2) and gynecare tot (n=1).In these type of meshes, seven had mesh exposure (gynecare prolift mesh kit [n=1], gynecare gynemesh ps [n=4], gynecare tvt secur [n=1], and gynecare tvt [n=1]) which required removal; and five patients had pain (gynecare prolift mesh kit [n=1], gynecare tvt secur [n=2], gynecare tvt [n=1], and gynecare tot [n=1]) which also required removal.Gynemesh ps caused a decrease in key structural proteins (collagen and elastin) and increased mmp activity that led to thinning of the underlying and associated tissues and a deterioration of mechanical properties.Gynemesh ps has a highly unstable geometry when loaded that resulted in pore collapse and increasing stiffness of the product.The findings of the present study suggest that the 2 major mesh complications (exposure and pain) are associated with a marked proinflammatory response that persists years after mesh implantation.In addition, different mechanisms for mesh exposure and pain may be associated with differential macrophage activation.

• 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: 7838419
• MDR Text Key: 118940129
• Report Number: 2210968-2018-75570
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2018
• 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