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

Catalog Number	3507555MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Breast Mass (2439)
Date of Event	12/04/2024
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: contralateral complication.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 patient underwent a primary breast augmentation surgery with implantation of a 555cc mentor memorygel breast implant prosthesis.Post-operatively, the patient reported experiencing a ruptured left breast implant which has confirmed using mammogram, ultrasound, and magnetic resonance imaging.Magnetic resonance imaging also identified a questionable mass in the right breast with a recommendation for further evaluation with additional imaging.A physical exam was conducted and barley any right distortion was noted.The exam also noted there were no masses in either breast.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6) 2025.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
On december 27, 2025, the mentor analysis lab received the suspect medical device for evaluation.On january 04, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection and leak test of the device.During visual evaluation, some bubbles within the gel were observed on the returned device.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.The shell wall of the implant is permeable to air, and trapped air can form bubbles with changes in pressure or temperature.When left by themselves with no changes in temperature or pressure, bubbles usually dissipate over time unless trapped by cured gel.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: 23811935
• Report Number: 1645337-2025-13907
• Device Sequence Number: 7621580
• Product Code: FTR
• UDI-Device Identifier: 00081317004257
• UDI-Public: (01)00081317004257(17)250308(10)9438907
• 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: 2021
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2025
• Device Catalogue Number: 3507555MC
• Device Lot Number: 9438907
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/27/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White