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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Fibrosis (3167)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.

Event Description

Title: chronic pain after tep inguinal hernia repair, does mri reveal a cause?.The study aimed to evaluate the role of mri in detecting causes of chronic pain following endoscopic hernia repair.A prospective cohort study was done between (b)(6) 2011 and (b)(6) 2012 comprising of 53 patients with chronic post-operative pain after total extraperitoneal (tep) hernia repair.Sixty seven groins out of 106 were operated; 14 patients had bilateral hernia repair.In 26 patients, a prolene mesh was used, in 14 patients ultrapro mesh, in 2 patients bard 3d mesh, in 2 patients physiomesh, in 1 patient a parietex mesh, and in 8 patients the type of mesh were unknown.Patients were untreated at the time of mri scanning and only used paracetamol in case of pain.Fibrosis was more often observed in painful operated groins than in unoperated groins.A trend towards significance was seen for the observation of fibrosis in painful groins.Moderate to extensive fibrosis was seen significantly more often when a prolene mesh had been used (in 13 of 26 patients) than after implantation of an ultrapro mesh (1 of 14 patients; p=0.02).Pain treatment included injections, implantation of a neuromodulating device, and physiotherapy.In patients with moderate to extensive fibrosis, pain diminished over time with or without treatment.In this study, mri in patients with post-tep hernia pain identified a correctly placed mesh, but it did not identify a specific cause for groin repair-related pain.Post-herniorrhaphy pain may be the result of different pathogenic mechanisms such as inflammatory response with concomitant fibrosis due to the presence of a mesh, mechanical irritation through the mesh and/or its fixation-device.Patients treated with a prolene mesh showed significantly more moderate to extensive fibrosis on mri compared to an ultrapro mesh, but numbers were small.It is generally agreed that meshes containing more material result in a more extensive inflammatory response resulting in more fibrosis.In conclusion, mri cannot be recommended to identify a specific cause for groin repair-related pain, but it does identify rare other causes of pain and to some extent does demonstrate the presence of (extensive) fibrosis.

• 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.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7498460
• MDR Text Key: 107771985
• Report Number: 2210968-2018-72672
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• 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: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1