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

Catalog Number	3508004BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Local Reaction (2035)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation surgery with implantation of an 800cc mentor memorygel breast implant prosthesis.Post-operatively, the patient experienced a swollen, firm, and painful left breast.A ruptured right implant was identified using ultrasound and computerized tomography imaging.She was diagnosed with left breast baker grade ii capsular contracture during a physical exam.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6)2026.
Additional Manufacturer Narrative
The complaint device has been discarded.  as a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.However, a photo of the suspect medical device was provided.An evaluation using the image was completed.Upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.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: capsular contracture, rupture, local reaction.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.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: 50936076
• Report Number: 1645337-2026-10816
• Device Sequence Number: 10749312
• Product Code: FTR
• UDI-Device Identifier: 00081317000587
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3508004BC
• Device Lot Number: 2034132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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 Sex: Female