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

Catalog Number	3505455BC
Medical Device Problem Codes	Material Rupture (1546); Use of Device Problem (1670)
Health Effect - Clinical Codes	Capsular Contracture (1761); Hematoma (1884); Deformity/ Disfigurement (2360)
Date of Event	10/10/2025
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: 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 46-year-old caucasian female patient underwent a primary breast augmentation with a 455cc mentor memorygel breast implant and experienced a rupture on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2025.
Additional Manufacturer Narrative
On december 16, 2025, the mentor failure analysis lab has received the device for evaluation.Mentor received additional information regarding the patient's experience.It was reported that the patient also experienced capsular contracture (baker grade unknown) and underwent multiple surgical interventions (capsulotomies) to address this issue.Due to this, the patient experienced a hematoma.The surgeon removed the breast prosthesis, "wash out" the hematoma, and placed the breast prosthesis back in.This is considered a user error and code a23 has been added in h6-medical device problem code.On january 05, 2026, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned device determined that the breast implant was found to be ruptured.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the anterior aspect, measuring approximately 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.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.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.Hematoma is a collection of blood within the space around the implant.Symptoms from hematoma may include swelling, pain, and bruising.If a hematoma occurs, it will most likely occur soon after surgery; however, it can occur at anytime, such as after an injury to the breast.Small hematomas may be absorbed by the body, while others may require surgery for drainage.Hematoma is a known complication associated with this procedure and is referenced in our product insert data sheet.Per mentor instructions for use (ifu), these devices are for single use only and should not be re-implanted.Re-use includes a risk of infection (microbial as well as viruses and transmissible agents) as well as immune responses.The sterility of the device can no longer be guaranteed.Therefore, these devices were used in an off-label manner.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 is conducted through complaint trending as part of post market surveillance.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 ; 9497882078
• MDR Report Key: 23610234
• Report Number: 1645337-2025-12929
• Device Sequence Number: 13062249
• Product Code: FTR
• UDI-Device Identifier: 00081317006961
• UDI-Public: (01)00081317006961(17)280515(10)9909402
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• 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 Catalogue Number: 3505455BC
• Device Lot Number: 9909402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White