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 Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240)

Event Date 03/24/2021

Event Type  Injury  

Event Description

It was reported in a journal article with title: the effects of onlay titanium-coated mesh on recurrence, foreign body sensation and chronic pain after ventral hernia repair.The aim of this study was to investigate the effects of onlay titanium-coated meshes (tcm) on recurrence, foreign body sensation and chronic pain in ventral hernia repair.Between may 2014 and january 2018, 160 patients with ventral hernia who underwent elective ventral hernia repair were included in the study.Patients were divided into 2 groups according to the mesh used: tcm (titanium group) or pm (polypropylene group).In the pm group, there were 97 patients with 54 females and 43 males with a mean age of 55.81 +/-12.77 years (range 26-75 years) and a mean bmi of 29.62 +/-3.26 kg/m2.All patients in the pm group were implanted with proline mesh (ethicon).In the tcm group, there were 63 patients who were implanted with a competitor's titanium-coated meshes.During the procedure, the hernia sac was closed with continuous sutures using 3/0 vicryl polyglactin 910 (ethicon) then the posterior sheath was closed with 2/0 vicryl polyglactin 910 (ethicon)and the anterior sheath was closed with an absorbable no.1 polydioxanone suture pds (ethicon).The meshes were fixed with 2/0 polypropylene suture to the anterior sheath.Subcutaneous tissue was closed with 3/0 vicryl suture polyglactin 910 (ethicon) and skin was sutured with 3/0 proline suture (ethicon).Clinical evaluation was routinely done for all patients at periods of 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months.Complications include surgical site infection (n=13), seroma (n=8), hematoma (n=3), hernia recurrence (n=1), foreign body sensation (n=11), and chronic pain; during physical activity (n=6), during coughing (n=3), and at rest (n=1).In conclusion, in onlay repair of ventral hernia, titanium-coated meshes led to less foreign body sensation and chronic pain than polypropylene mesh.The surgical site infection was associated with recurrence for these meshes.Additionally, the increase in defect size causes a risk for foreign body sensation and chronic pain in repair using polypropylene mesh.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-00825, 2210968-2022-00826 and 2210968-2022-00827.Citation: asian journal of surgery, volume 44 (2021), pages 1158-1165; https://doi.Org/10.1016/j.Asjsur.2021.02.022 please see article attached.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13539365
• MDR Text Key: 285679735
• Report Number: 2210968-2022-01100
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• 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?: No
• Date Manufacturer Received: 03/06/2023
• 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