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

Catalog Number	3541158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing of the device.Visual analysis of the returned device revealed bubbles within the gel.Leak testing was performed, according with mentor procedure, and no areas of gel exposure were found.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.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: anisomastia.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 surgery with implantation of a 245cc mentor memoryshape breast implant prosthesis.Post-operatively, the patient had a biopsy of the left breast due questionable findings on mammogram.Findings were negative, but it was suspected the intervention may have damaged the implant.Subsequently, she was diagnosed with a ruptured left implant and the beginnings of waterfall deformities, bilaterally, during a physical exam.Magnetic resonance imaging confirmed the rupture.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6) 2025.This report is for the right breast prosthesis.

• Brand Name: MENTOR MEMORYSHAPE 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: 23374058
• Report Number: 1645337-2025-11892
• Device Sequence Number: 13244814
• Product Code: FTR
• UDI-Device Identifier: 00081317005445
• UDI-Public: (01)00081317005445(17)190331(10)6812867
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 3541158
• Device Lot Number: 6812867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2014
• 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: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White