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); Hernia (2240); Post Operative Wound Infection (2446)

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.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that 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 the ethicon products used in this procedure? citation: hernia.2015; 19: 383¿387.Doi: 10.1007/s10029-015-1350-0.(b)(4).

Event Description

It was reported via journal article: "title: prospective randomized clinical trial of jean rives technique versus laparoscopic tep repair for primary inguinal hernia: 10-year follow-up" authors: k.Tomaoglu, y.S.Sari, h.Bektas, o.Koc, e.Gunes, g.Uzum, m.Kucukyilmaz citation: hernia.2015; 19: 383¿387.Doi: 10.1007/s10029-015-1350-0.The purpose of the present randomized trial was to compare the jean rives (jr) technique and the laparoscopic totally extraperitoneal (tep) repair for the treatment of primary inguinal hernias with respect to operating time, hospital stay, sick leave, chronic pain, and recurrences after a follow-up of 10 years.A total of 110 patients with primary inguinal hernia were randomized to either a jr repair (53 patients; mean age: 40.54 ± 4.52) or to a laparoscopic tep repair (57 patients; mean age: 41.19 ± 2.82) and were included in the study.During the jr repair procedure, the synthetic prosthesis, prolene mesh (ethicon) of 12 × 8 cm dimensions was arranged in the preperitoneal space so that the material stretches transversely and fixed inferiorly to the cooper¿s ligament by three applications of tacker.The mesh was fixed medially to the posterior face of rectus muscle and laterally to the inguinal ligament by prolene 0 non-absorbable sutures (ethicon).In the jr group, reported complications included post-operative wound infection (n-1), chronic pain (n-2), and recurrences (n-2).It was reported that the long-term results has brought to light that the tep technique and the jr technique were equally efficient.The jr technique was significantly advantageous in terms of operating time.The jr technique is a relatively easy technique to perform, requires shorter operating time when compared to laparoscopic tep technique.Jr technique should be taken into consideration while planning surgical treatment of inguinal hernia.

• 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.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7929816
• MDR Text Key: 122483916
• Report Number: 2210968-2018-76258
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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: 09/10/2018
• 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
• Treatment: PROLENE SUTURE
• Patient Outcome(s): Required Intervention