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

Catalog Number	3502251BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Some breast ptosis is a normal component of the mature breast.Ptosis becomes undesirable when the breast parenchyma predominates below the areola, droops considerably below the inframammary fold and the nipple points downward.Augmentation alone, without consideration of the ptosis can produce a less than desirable cosmetic result known as a ¿¿rock in sock¿¿ deformity or an increased ptotic appearance.Ptosis 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.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: breast ptosis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 44-year-old caucasian female patient underwent a primary breast augmentation with a 225cc mentor memorygel breast implant and experienced breast ptosis on the left side post-operatively.As a result, the patient underwent explantation on (b)(6) 2026 and replaced with a 275cc mentor memorygel breast implant.

• 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: 24890866
• Report Number: 1645337-2026-04476
• Device Sequence Number: 9851683
• Product Code: FTR
• UDI-Device Identifier: 00081317000259
• UDI-Public: (01)00081317000259(17)220924(10)7511551
• 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: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 09/24/2022
• Device Catalogue Number: 3502251BC
• Device Lot Number: 7511551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White