MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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

Patient Problems Necrosis (1971); Post Operative Wound Infection (2446)

Event Date 01/01/2021

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 regarding the additional events.   citation: plastic and reconstructive surgery: march 2021; volume 147 (3): p 580-584. Doi: 10. 1097/prs. 0000000000007638.   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 product (vicryl mesh) 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 product involved?.

Event Description

It was reported in a journal article with title: splitting the difference: using synthetic and biologic mesh to decrease cost in prepectoral immediate implant breast reconstruction. The purpose of this retrospective study was to analyze reconstructive outcomes with an acellular dermal matrix sling and vicryl tension band technique as a means of decreasing cost in prepectoral breast reconstruction. A total of 11 patients (21 breasts; average age
=
47. 8 ± 1. 3 years; mean bmi
=
29. 1± 1. 1) who underwent prepectoral immediate implant breast reconstruction with vicryl mesh (ethicon) and acellular dermal matrix anterior coverage, were included in the study. Reported complications included minor infection (n
=
1) which resolved with oral antibiotics, minor mastectomy flap necrosis (n
=
1) and partial nipple necrosis (n
=
1) which resolved with local wound care. In conclusion, prepectoral breast reconstruction using acellular dermal matrix inferiorly and vicryl mesh superiorly is a safe technique that decreases material costs associated with support materials and allows the surgeon to precisely control the implant pocket and position.

• Brand Name: VICRYL POLYGLACTIN 910 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.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12020470
• MDR Text Key: 267561028
• Report Number: 2210968-2021-05650
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/17/2021 Patient Sequence Number: 1