MAUDE Adverse Event Report: Mentor Texas MENTOR MemoryGel Breast Implant; Prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	3507325BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with mentor memorygel breast implants experienced bilateral capsular contracture baker grade unknown and rupture on the left side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent device removal and replacement.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation, where a thorough investigation was conducted.Visual analysis of the returned device revealed that the breast implant was found to have a tear on the posterior view, measuring approximately 2.0 cm.In addition, shell abrasion was noted on the edges of the rupture.These findings are consistent with normal wear of the device.Shell abrasion suggests in-vivo folding or creasing of the device, which may be caused by continuous and sustained stresses to the device, such as an excessively small breast pocket or the folding or wrinkling of the shell within the breast pocket.In some cases, breast implants may also experience normal wear over time.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria, and that normal wear may have caused the observed defect.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.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: capsular contracture.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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; +1(949)788-2078
• MDR Report Key: 50734834
• Report Number: 1645337-2026-10125
• Device Sequence Number: 10661998
• Product Code: FTR
• UDI-Device Identifier: 00081317000105
• UDI-Public: (01)00081317000105(17)150630(10)6002366
• 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: 2011
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 3507325BC
• Device Lot Number: 6002366
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2010
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Race: White