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

Catalog Number	3507255MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Deformity/ Disfigurement (2360)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.A breast cyst is a fluid-filled sac within the breast.One breast can have one or more breast cysts.They are often described as round or oval lumps with distinct edges.Breast cysts are usually and typically do not require treatment, but they can be drained using fine needle aspiration if the cyst is large or uncomfortable.Asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry is a known complication associated with these devices and is referenced in our current product insert data sheet.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: asymmetry.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 255cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured left breast implant using an magnetic resonance imaging, left breast baker grade iii capsular contracture, and bilateral breast asymmetry.Mammogram and ultrasound imaging were also conducted which identified suspicious calcifications and a mass in the left breast.Biopsies were recommend for further evaluation.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6) 2025.During the surgery, a cystic mass of the right breast was discovered which was released.This report is for the right 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 ; 9497882078
• MDR Report Key: 23927960
• Report Number: 1645337-2025-14453
• Device Sequence Number: 15659646
• Product Code: FTR
• UDI-Device Identifier: 00081317004127
• UDI-Public: (01)00081317004127(17)200304(10)6910388
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: 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: 03/04/2020
• Device Catalogue Number: 3507255MC
• Device Lot Number: 6910388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2015
• 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: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White