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 Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240); Post Operative Wound Infection (2446); Neuralgia (4413)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint (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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to clarify 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 ethicon products (prolene mesh and vicryl suture) involved caused and/or contributed to the post-operative complications (seroma, wound infection, urinary retention, neuralgia,hernia recurrence, post-op pain) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon product (prolene mesh and vicryl suture) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (seroma, wound infection, urinary retention, neuralgia,hernia recurrence, post-op pain).Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.If available, please provide prolene mesh and vicryl suture product codes/lot numbers used in these cases.Citation: 2019 formosan journal of surgery, formos j surg 2019;52:212-20.Events were submitted 2210968-2021-03067.

Event Description

Title: comparison of mesh fixation and nonfixation in laparoscopic transabdominal preperitoneal repair of inguinal hernia.The aim of this present randomized clinical trial was to evaluate the incidence rate of complications such as urinary retention, seroma, wound infection, and recurrence of hernia, after applying two methods of fixed and nonfixed tapp in an iranian population during 6 months after operation.In addition, this study evaluated the patients¿ pain level and made attempts to report more accurate results by distinguishing the direct and indirect types of hernia.Between april 2017 to march 2018, a total of 80 patients with inguinal hernia underwent tapp laparoscopy with mesh fixation (n = 41; 31 male and 10 female; mean age = 50.51 ± 10.23 years) and nonfixation (n = 39; 32 male and 7 female; mean age = 53.87 ± 8.37 years) in al zahra hospital.Surgery was performed in both groups using a harmonic scalpel (ethicon) and a 10 cm × 15 cm-mesh (prolene mesh; ethicon).Mesh was fixed using a competitor suture or spiral tacks in group a and nonfixed in group b.Continuous absorbable sutures (vicryl 3/0; ethicon) were used to close the peritoneum in both groups.Reported complications included death (n=?); seroma (n=3), urinary retention (n=14), neuralgia (n=11), postoperative pain score of 3.61±2.35 at 1 day after surgery (n=?), postoperative pain score of 3.34±2.26 prior to discharge (n=?), postoperative pain score of 2.76±1.62 at 1 week after surgery (n=?), postoperative pain score of 2.34±1.37 at 2 weeks after surgery (n=?), postoperative pain score of 1.32±1.47 at 1 month after surgery (n=?), and postoperative pain score of 0.66±1.17 at 6 months after surgery (n=?) in group a.While seroma (n=2), wound infection (n=2), urinary retention (n=5), neuralgia (n=1), hernial recurrence (n=2), postoperative pain score of 3.00±2.22 at 1 day after surgery (n=?), postoperative pain score of 2.03±2.18 prior to discharge (n=?), postoperative pain score of 1.74±1.50 at 1 week after surgery (n=?), postoperative pain score of 1.41±1.29 at 2 weeks after surgery (n=?), postoperative pain score of 1.00±0.92 at 1 month after surgery (n=?), and postoperative pain score of 0.26±0.59 at 6 months after surgery (n=?) in group b.In conclusion, mesh nonfixation causes less postoperative complications and pain in patients undergoing tapp repair; however, in long-term follow-up, the level of chronic pain following the application of mesh fixation and non-fixation methods is not different.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11624502
• MDR Text Key: 260982452
• Report Number: 2210968-2021-03064
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1