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

Catalog Number	3501501BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Granuloma (1876)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 63-year-old caucasian female patient underwent a primary breast augmentation with a 150cc mentor memorygel breast implant and experienced breast implant rupture on the left side complicated by silicone granuloma formations in the left breast.It was also reported that the patient developed capsular contracture (baker grade3) post-operatively.The patient reported hardness with pain.As a result, the patient underwent explantation on (b)(6) 2025.
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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: capsular contracture, granuloma, and 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).
Additional Manufacturer Narrative
On june 30, 2025, mentor received additional information reporting that the patient's capsular contracture's baker grade was baker grade 4.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On december 27, 2025, mentor received additional information regarding the patient's event.The patient reported feeling "increasing hardness, persistent pain, and burning" on the breast despite massaging with singular.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 14, 2026, mentor received additional information regarding the patient's experience.It was reported that due to the capsular contracture, the patient's breast was higher than the contralateral side.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: 22071603
• Report Number: 1645337-2025-05657
• Device Sequence Number: 8702495
• Product Code: FTR
• UDI-Device Identifier: 00081317000228
• UDI-Public: (01)00081317000228(17)251213(10)9522599
• 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,Followup,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: 12/13/2025
• Device Catalogue Number: 3501501BC
• Device Lot Number: 9522599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 12/27/2025; 01/14/2026
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/21/2025; 01/13/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2020
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White