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

Catalog Number	3503504BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Upon visual evaluation of the image provided in the complaint, the implant was observed to be ruptured.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.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.Reason for device explant and/or reoperation: left breast prosthesis rupture diagnosed via mammogram.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).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation procedure with mentor memorygel breast implant gel breast prostheses when the left breast prosthesis ruptured post implantation.Rupture of the patient¿s left breast prosthesis was diagnosed via mammogram.As a result, the patient underwent bilateral explantation and replacement with mentor memorygel boost breast implant gel breast prostheses.During explant surgery, it was noted that both left and right breast prostheses had ruptured.This medwatch report is for the patient¿s right breast prosthesis.Refer to manufacturer report number 1645337-2026-08879 for the report for the patient¿s left breast prosthesis.

• 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: 50380897
• Report Number: 1645337-2026-09412
• Device Sequence Number: 9681328
• Product Code: FTR
• UDI-Device Identifier: 00081317000488
• UDI-Public: (01)00081317000488(17)200121(10)6898158
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup

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: 01/21/2020
• Device Catalogue Number: 3503504BC
• Device Lot Number: 6898158
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2015
• 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