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

Catalog Number	SMPX240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
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: inflammation/irritation/swelling.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).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision with a 240cc mentor memorygel xtra breast implant and experienced a local reaction on the right side post-operatively.The patient had experienced inflammation/irritation/swelling.As a result, the patient underwent explantation on (b)(6) 2025 and replaced with a 240cc mentor memorygel xtra breast implant (catalog number smpx240).
Additional Manufacturer Narrative
On may 25, 2025, a photo evaluation for the device was completed.Photo evaluation summary: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Swelling is a temporary normal post-operative condition.Depending on presentation, delayed swelling may require additional work-up by the surgeon.Swelling is a known complication associated with these devices and is referenced in our current product insert data sheet.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 15, 2025, the mentor failure analysis lab has received the device for evaluation.The patient identifier was updated to (b)(6).On july 20, 2025, the evaluation for the device was completed.Device evaluation summary: during visual evaluation no apparent damage or visual anomalies were observed on the returned device.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.Swelling is a temporary normal post-operative condition.Depending on presentation, delayed swelling may require additional work-up by the surgeon.Swelling is a known complication associated with these devices and is referenced in our current product insert data sheet.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• 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: 22054720
• Report Number: 1645337-2025-05509
• Device Sequence Number: 6950950
• Product Code: FTR
• UDI-Device Identifier: 00081317025009
• UDI-Public: (01)00081317025009(17)290721(10)9993931
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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 Catalogue Number: SMPX240
• Device Lot Number: 9993931
• 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: 04/27/2025
• Supplement Date Received by Manufacturer: 05/25/2025; 07/15/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/16/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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 Sex: Female