MAUDE Adverse Event Report: Mentor Texas MENTOR MemoryGel BOOST Breast Implant; Prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SMPB480
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 59-year-old caucasian female patient underwent revision breast augmentation with 480cc mentor memorygel boost breast implant and experienced capsular contracture; baker grade iii on her left side; diagnosed after physical exam.The patient has consulted with the healthcare professional.As a result, the patient underwent replacement surgery with unknown gel devices on (b)(6)2026.
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: left capsular contracture; baker grade iii.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 (b)(6) 2026, mentor became aware that the patient's left side implant was folded in the breast pocket due to contraction of the implant, and also mild lateral displacement of right implant was reported.Right device is still implanted and at the time of this report, mentor has received no information regarding explantation or an expected explantation date of the right side device.This supplemental medwatch report is for the patient¿s left-sided device.Right side displacement is being reported separately.Manufacturer¿s reference number pc-(b)(4).
Additional Manufacturer Narrative
Device problem code wrinkles/ripples (post implant) replaced with shell irregularities (post implant) since information received on september 29, 2026 indicated ¿there was a defined fold in the left implant¿ and ¿i elected to replace the implant with a new implant given.The permanent fold of the implant¿ once the implant was removed from the patient.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number (b)(4).

• Brand Name: MENTOR MemoryGel BOOST 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 ; +1(949)788-2078
• MDR Report Key: 50690517
• Report Number: 1645337-2026-09822
• Device Sequence Number: 14934445
• Product Code: FTR
• UDI-Device Identifier: 00081317026914
• UDI-Public: (01)00081317026914(17)300417(10)2069447
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SMPB480
• Device Lot Number: 2069447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/15/2026; 09/17/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/18/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2025
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White