MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3543407MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); Swollen Lymph Nodes/Glands (4432)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(64) caucasian female patient underwent a breast augmentation revision with a mentor memorygel breast implant 340cc and experienced breast pain and device rupture on the right side.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2022, additional information was received indicating the explantation surgery is scheduled for (b)(6) 2022.The date of implantation was identified as (b)(6) 2013.Reason for device explant and/or reoperation: breast pain, rupture manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 13 2022, additional information was received indicating the patient also experienced capsular contracture baker grade unknown on the right side and bilateral ptosis.The date of explantation was identified as (b)(6) 2022.This report is for the right breast prosthesis.On may 20 2022, the mentor failure analysis lab received the device for evaluation.On jun 5 2022, an evaluation of a photo of the device was completed.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.On jun 6 2022, the physical device evaluation was completed.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the gsx mod classic gel, 340cc breast implant had parallel lines of shell wear on the anterior aspect.Leak testing was performed, according to the mentor procedure, and it identified a tear within an area of shell abrasion on the posterior view, measuring approximately 0.3 cm.No additional leaks were detected during the leak testing.The evaluation determined that the cause of the rupture was consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.It should be noted that as part of the mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jun 10, 2022, additional information was received indicating the patient also experienced lymphadenopathy on the right side.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 8689274
• Report Number: 1645337-2019-13648
• Device Sequence Number: 2358837
• Product Code: FTR
• UDI-Device Identifier: 00081317004417
• UDI-Public: 00081317004417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 3543407MC
• Device Catalogue Number: 3543407MC
• Device Lot Number: 6782311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 02/22/2022; 05/13/2022; 06/10/2022
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 03/20/2022; 06/09/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White