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

Catalog Number	3504001BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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: capsular contracture and rupture.\ \ 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.\ \ manufacturer¿s reference number:\ (b)(4).
Event or Problem Description
It was reported that a 48-year-old caucasian female patient underwent a breast augmentation with two 400cc mentor memorygel breast implants and experienced a rupture and capsular contracture (baker grade 2) on the right side and device migration (laterally) on the left side post-operatively.The patient reported having pain and breast ptosis on the right side.As a result, the patient underwent explantation on (b)(6) 2026.\ \ this report is for the right side device.
Additional Manufacturer Narrative
On september 17, 2026, a photo evaluation for the device was completed.\ \ photo evaluation summary:\ \ upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.\ \ as the product involved in this complaint was discarded , the device could not be analyzed according to our procedures.\ \ 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: no corrective and preventive action (capa) is required now.\ \ additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.\ \ on september 23, 2026, mentor received additional information reporting that the patient's replacement device was a mentor breast prosthesis.\ \ on october 01, 2026, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.\ \ 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: 50809886
• Report Number: 1645337-2026-10424
• Device Sequence Number: 21478117
• Product Code: FTR
• UDI-Device Identifier: 00081317000327
• 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: 2007
• 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 Expiration Date: 11/29/2011
• Device Catalogue Number: 3504001BC
• Device Lot Number: 5716439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2006
• 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: 48 YR
• Patient Sex: Female
• Patient Race: White