MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problems Wound Dehiscence (1154); Scar Tissue (2060); Insufficient Information (4580)

Event Date 01/24/2022

Event Type  Injury  

Event Description

Title: reoperative augmentation mammoplasty: an algorithm to optimize soft-tissue support, pocket control, and smooth implant stability with composite reverse inferior muscle sling (crims) and its technical variations.The objectives of this study was to revisit a previously described predictable approach in primary breast augmentation and defines a surgical treatment algorithm for ram technique selection.Between 2017 and 2021, 72 patients (144 breasts) underwent ram with composite reverse inferior muscle sling (crims) technique and its technical variations (types i¿iv).Crims technique involves placing a silicone gel implant into the submuscular (sm) pocket with an inferior sling of the pectoralis major muscle based on the dimensions of the implant, in combination with support points/dermal bridge sutures to stabilize the implant and glandular tissue at the lower breast pole (lbp).Reasons for surgery were ptosis (92%), implant and malposition (59.6%).Patients were followed for at least 6 months in 5 cases (6.9%), at least 12 months in 50 cases (69.4%), for at least 36 months in 10 cases (13.8%), and more than 36 months in 7 cases (9.7%) (mean 34 months; range 6¿48 months).Nylon 2-0, mersilene 2-0 suture and 3-0 and 4-0 vicryl suture were used.Reported complications included hypertrophic scars (n=4), wound dehiscence (n=4), asymmetry (n=1), displacement (n=1) in conclusions crims and its variations can be performed successfully in ram.An algorithmic approach can facilitate the pre- and intraoperative decision-making process and provide the new pocket control and implant stability with acceptable complication rates.Further accurate evaluation is recommended to understand the benefits or disadvantages of crims compared to other ram techniques.

Manufacturer Narrative

(b)(4).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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? 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 2210968-2023-00075, and 2210968-2023-00076.Citation: aesth plast surg (2022) 46:1116¿1132.Https://doi.Org/10.1007/s00266-021-02726-1.

• Brand Name: NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16098968
• MDR Text Key: 306682171
• Report Number: 2210968-2023-00074
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• 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
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• 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: 12/19/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention