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 Seroma (2069); Insufficient Information (4580)

Event Date 02/01/2021

Event Type  Injury  

Event Description

Title: the 10-year experience with volume distribution mastopexy: a novel, safe, and efficient method for breast rejuvenation.This study presents a clinical experience with the volume distribution mastopexy technique over the past 10 years.Between 2010 and 2020, 50 patients (mean age of 41 years) operated on for mastopexy or contralateral symmetrization following breast reconstruction were included in the study.A vicryl mesh (ethicon) was used in the first 23 patients, and a mixed competitor¿s mesh was used in the following 27 patients.During the procedure, a 2-0 vicryl suture (ethicon) was used to anchor the central flap to the pectoralis fascia cephalad.If more projection is desired, the flap can be folded onto itself with plicating sutures using 2-0 vicryl suture (ethicon).Ultimately, the flap is wrapped and secured in place using a mesh that is fixed onto the fascia using 2-0 vicryl suture (ethicon).The areola is sutured using the interlocking purse-string technique.The vertical scar may then be closed using inverted figure-of-eight deep dermal boxing sutures using 3-0 vicryl suture (ethicon) to shorten it to 6 to 8 cm.Final closure is done using 3-0 and 4-0 monocryl (ethicon) for the vertical incision and the areola, leaving also a drain in the site.A surgical bra is recommended for the first 4 weeks.Sports and strenuous activities are avoided for 6 weeks.At an average of 18-month follow-up (range, 3 to 36 months), the sternal notch¿to-nipple distance and the lower pole distance were measured.The clinical follow-up was 3 years on average (range, 3 to 108 months).Complications include wound dehiscence (n=1) and persistent breast asymmetry with lateral fullness which required repeated mastopexy (n=1).In conclusion, the volume distribution mastopexy technique repositions the ptotic gland with a mesh to suspend the breast gland and to maintain the lifting effect.However, the synthetic mixed mesh proved to be significantly more effective in achieving this goal.

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.Does the surgeon believe that any of the ethicon products (vicryl mesh, vicryl suture, monocryl suture) involved caused and/or contributed to the post-operative complications described in the article? 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? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via / events were submitted via 2210968-2022-02755 and 2210968-2022-02756.Citation: plast.Reconstr.Surg., volume 148, pages 55-64, july 2021; doi: 10.1097/prs.0000000000008112.

Manufacturer Narrative

(b)(4).Date sent to the fda: 4/19/2022.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 inc 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: 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 strass1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14140390
• MDR Text Key: 289488784
• Report Number: 2210968-2022-02754
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention