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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Obstruction/Occlusion (2422)

Event Date 05/22/2021

Event Type  Injury  

Event Description

It was reported in a journal article with title: laparoscopic total extraperitoneal repair and open prolene hernia system for inguinal hernia repair have similar outcomes: a retrospective study.The objectives of this study was to compare the results of laparoscopic total extraperitoneal inguinal hernia repair (ltepr) and the open prolene hernia system repair (ophsr), in terms of complications, postoperative pain and quality of life.All consecutive patients who underwent ltepr of an inguinal hernia from 2003 to 2007 and open ophsr inguinal hernia repair from 2008 to 2015, were analyzed.A total of 577 patients were included in the study divided into two groups, the ltepr group 293 patients and in the ophsr group 284 patient.The average age for ophsr was 62.49 years and for ltepr 55.35 years.For ltepr to repair the groin, the surgeon use a heavyweight polypropylene mesh 15 x 15 centimeters, divided in a piece of 15 x 5 centimeter inserted under the cord and fixed with helical tackers to the ramus pubis and laterally to the transverse abdominal muscle.The second piece of mesh, 10 x 15 centimeter above the cord overlapping the anterior piece and fixing it to the first mesh inserted.For ophsr the posterior patch of the phs prolene® hernia system (ethicon) was introduced pre-peritoneally and the onlay patch was fixed with continuous polypropylene sutures(ethicon).Reported complications included hematoma (n=34), urinary tract infection (n=3), fever (n=6), urinary retention (n=9), infection (n=1), small bowel obstruction (n=1), seroma (n=6), hernia recurrence (n=12), pain in conclusion ltepr has shorter operative time, more intraoperative complications.Ophsr and ltepr have similar postoperative complications, recurrences, pain, and qol.Inguinal hernia repair by open phs or laparoscopic tep approach has a similar outcome.

Manufacturer Narrative

Product complaint #: (b)(4).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).Device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: chirurgia, 116 (3), 2021 http://dx.Doi.Org/10.21614/ chirurgia.116.3.271.Adverse events associated with prolene polypropylene suture device reported via mw # 2210968-2022-00878.Adverse events associated with prolene hernia system mesh device reported.

• Brand Name: PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC MEDICAL; 25 centre road; somersworth NH 03878
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13608788
• MDR Text Key: 292481665
• Report Number: 2210968-2022-01339
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K984220
• 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
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2022
• 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