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

Catalog Number	3507450BC
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Breast Discomfort/Pain (4504)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.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 450cc mentor memorygel breast implant prosthesis.Post-operatively, the patient reported experiencing bilateral breast pain, left breast shooting pains and tingling/itching sensation, and a left implant that never dropped which appeared disfigured.She was diagnosed with a ruptured left implant using ultrasound and magnetic resonance imaging.A consultation with a medical professional was scheduled.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
On september 26, 2025, mentor received the patient's date of birth.Date of birth: (b)(6) 1953.A planned surgery date of (b)(6) 2025 was reported.On september 29, 2025, the following additional information was received: the patient, who was involved in a clinical study, was implanted with the suspect devices during a breast augmentation revision surgery.The patient was diagnosed with bilateral baker grade iv (left-sided) and ii (right-sided) capsular contracture with associated pain and tightness, bilateral double capsules, and bilaterally ruptured implants by a medical professional using the patient's symptoms.An updated implant date was provided.Date of implantation: (b)(6) 2000.Race: white.A planned surgery date of (b)(6) 2025 was reported.On (b)(6) 2025, the planned surgery was cancelled and not rescheduled.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 14, 2025, 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.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: 23005872
• Report Number: 1645337-2025-09910
• Device Sequence Number: 21458205
• Product Code: FTR
• UDI-Device Identifier: 00081317000143
• UDI-Public: 00081317000143
• 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: 2000
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• 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 Expiration Date: 08/31/2005
• Device Catalogue Number: 3507450BC
• Device Lot Number: 217574
• 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: 08/23/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 11/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/23/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2000
• 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: Other
• Patient Sex: Female
• Patient Race: White