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

Catalog Number	SHPX450
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Crushing Injury (1797); Local Reaction (2035)
Date of Event	09/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d 6b.Explantation date: (b)(6) 2026.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: swollen breast and possible material rupture due to trauma.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 primary breast augmentation with two 450cc mentor memorygel xtra breast implants.Post-operatively, the patient suffered trauma to the right breast during a baseball game.The right breast became swollen and the patient was diagnosed, via ultrasound, with possible right breast implant rupture.As a result, the patient has been scheduled for breast implant removal surgery on (b)(6) 2026.
Additional Manufacturer Narrative
On january 14, 2026, mentor received additional information that indicated that the patient's right breast implant was replaced with another mentor gel implant.
Additional Manufacturer Narrative
On february 2, 2026, mentor received additional information that indicated that the patient also experienced left breast deformity, discomfort and firmness.During removal, the implant was identified to be intact but had two linear indentations.On february 9, 2026, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: after clinical review of this file performed on (b)(6) 2026, it was decided to add medical device problem code, a24, to more accurately capture the reported event.On march 10, 2026, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the breast implant.The event described could not be confirmed as the breast implant was returned without shell irregularities.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Inflammation is part of the complex biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or irritants, and is a protective response involving immune cells, blood vessels, and molecular mediators.The function of inflammation is to eliminate the initial cause of cell injury, clear out necrotic cells and tissues damaged from the original insult and the inflammatory process, and to initiate tissue repair.The classical signs of inflammation are heat, pain, redness, swelling, and loss of function.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some breast and/or chest inflammation postoperative.While inflammation normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Inflammation is a known complication associated with this type of procedure and is referenced in the current ifu.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.

• Brand Name: MENTOR MEMORYGEL XTRA 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: 23608340
• Report Number: 1645337-2025-12906
• Device Sequence Number: 9259393
• Product Code: FTR
• UDI-Device Identifier: 00081317025283
• UDI-Public: (01)00081317025283(17)250602(10)9470313
• 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
• 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: 06/02/2025
• Device Catalogue Number: SHPX450
• Device Lot Number: 9470313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/02/2026; 02/24/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/02/2026; 02/24/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White