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

Catalog Number	3507255MC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 57-year-old caucasian female patient underwent primary breast augmentation with unknown size unknown gel implants and experienced breast implant rupture on her right side.The patient underwent bilateral replacement surgery with catalog number 3503251bc; serial number (b)(6) on the left side, and with catalog number 3503501bc; serial number (b)(6) on the right side on (b)(6) 2025.On november 10, 2025, the mentor failure analysis lab received two devices for evaluation.According to the information received, the patient experienced deflation of the right-side implant.No product quality issues were reported for the left-side device.Mentor is aware that the date of implant is before the manufacture date of lot 6713581.However, follow-ups have been completed and no response has been received regarding the date.If any clarification or information is received in the future, a supplemental report will be submitted.Since no serial number was available on the returned devices, it was not possible to determine which device corresponded to the right-side breast implant, therefore, both devices were analyzed.For reporting purposes, this report details evaluation of device lot number 6713581.Results for lot 6716226 are being reported separately under manufacturer report number 1645337-2025-11603.
Additional Manufacturer Narrative
On november 25, 2025, device evaluation was completed as follows: mentor conducted visual inspection of the returned device.Visual analysis of the returned device b revealed a tear within an area of shell abrasion on the anterior view, measuring approximately 0.1 cm.These findings are consistent with normal wear of the device.Shell abrasion suggests in-vivo folding or creasing of the device, which may be caused by continuous and sustained stresses to the device, such as an excessively small breast pocket or the folding or wrinkling of the shell within the breast pocket.In some cases, breast implants may also experience normal wear over time.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, and that normal wear may have caused the observed defect.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: na.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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).

• 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: 23659797
• Report Number: 1645337-2025-13224
• Device Sequence Number: 20026265
• Product Code: FTR
• UDI-Device Identifier: 00081317004127
• UDI-Public: 00081317004127
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 3507255MC
• Device Lot Number: 6713581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2013
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White