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 Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

(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 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 any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify.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? (b)(4) ¿ device not returned.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 regarding the additional events.Citation: https://doi.Org/10.1080/2000656x.2020.1856673.

Event Description

Title: reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap.A prospective double-blind randomized study.The aim of the present study was to compare donor-site morbidity after reinforcement of the abdominal wall.Regarding development of bulging or hernia, abdominal muscle strength, complications, and abdominal pain hypothesizing that reinforcement with acellular dermal matrix strattice is superior to reinforcement with synthetic mesh prolene (ethicon).A total of 29 patients were included in the study.After randomization 14 patients were assigned to reinforcement of the abdominal donor-site with adm and 15 patients to reinforcement with synthetic mesh prolene (ethicon).No patients were lost to follow-up.Reported complication included bulging frequency (6.7% ;n=1) and necrosis (n=2).In conclusion the present study did not demonstrate any statistically significant differences between treatment.Groups regarding risk of bulging or hernia, abdominal muscle strength, complications, pain or pain related qol within two years of follow-up.Although the small sample size sets limitations for drawing wide conclusions the hypothesis that reinforcement with adm is superior to synthetic mesh cannot be confirmed.Further research into methods for decreasing donor-side morbidity related to the tram flap or other rectus abdominis muscle-based flaps is needed.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/22/2021.Additional information was requested and the following was obtained: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify.No.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.No.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.No.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, 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.Product complaint # (b)(4).Date sent to the fda: 5/22/2021.Corrected information:  b1, h1:  additional information was received that this device was not involved in the event.  therefore, this medwatch report will be voided.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, 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
• MDR Report Key: 11712268
• MDR Text Key: 261742550
• Report Number: 2210968-2021-03646
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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: 04/23/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1