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 Unspecified Infection (1930); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); Not Applicable (3189); No Code Available (3191)

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.Citation: iosr journal of dental and medical sciences (iosr-jdms).2013; 10(6): pp 08-10.(b)(4).

Event Description

It was reported via journal article: "title: outcomes of laparoscopic ventral hernia repair as compared to open repair, in a tertiary care government hospital in north india." author: dr gaurav goyal, dr ashok kumar mathur, dr.Shalu gupta, dr.Neetu aggarwal citation: iosr journal of dental and medical sciences (iosr-jdms).2013; 10(6): pp 08-10.The authors undertook a prospective non-randomized study of ventral hernia cases from 1st october 2010 to 30th september 2011, at sawai man singh hospital, a tertiary care government hospital in north india.A total of 30 cases were done (13male and 17 female patients), 15 by laparoscopic and 15 by open repair.The laparoscopic ventral hernia repair was done using 10 mm 0 and 30 degree telescopes.Either prolene polypropylene mesh (ethicon) or proceed dual mesh (ethicon) of appropriate size, giving atleast 3 cm overlap to the hernia defect, was used depending on the affordability of the patient.In all patients, the mesh was placed intraperitoneally.In all cases, the mesh was fixed to the full thickness of the abdominal wall using transabdominal prolene 2-0 sutures (ethicon), placed at fixed intervals along the margin of the defect.In the open mesh repair of ventral hernia, the prolene polypropylene mesh (ethicon) was then placed correspondingly in an onlay fashion with atleast 3 cms overlap over the defect and fixed using prolene 2-0 sutures (ethicon).Suction drains used in all cases.In the laparoscopic ventral hernia repair group, reported complications included paralytic ileus (n-4) and seroma (n-10).In the open mesh repair of ventral hernia, reported complications included paralytic ileus (n-5), seroma (n-3), wound infection (n-6), mesh infection (n-2) which required subsequent mesh removal, and hernia recurrence (n-3).Laparoscopic repair of ventral hernia is a safe and effective technique with lesser post-operative pain, shorter hospital stay and no wound infections.Seroma formation is very common but it doesn¿t adversely affect outcomes.Our study found no mesh infection and no recurrence of hernia at 6 months follow up in the laparoscopic group.Hence, laparoscopic repair should be preferred method of treatment of ventral hernias.

Manufacturer Narrative

(b)(4).Attempts have been 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.If yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (prolene mesh, proceed mesh, and prolene suture) 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 involved?.

• 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
• MDR Report Key: 8887786
• MDR Text Key: 154124979
• Report Number: 2210968-2019-85467
• 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
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 07/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention