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

Catalog Number	SMPB290
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A female patient who underwent breast surgery with a mentor memorygel boost 290 cc silicone prosthesis was identified intraoperatively with a deformed device (side unknown).During insertion of a 290 cc boost moderate plus implant, the device repeatedly disengaged from the funnel.Inspection identified a pronounced indented crease across the superior aspect of the implant manual manipulation and a rest period did not resolve the crease.Although partial improvement was later noted on the back table, the device was not used due to concern for potential rupture or other integrity issues.A backup implant was used.No adverse event was reported.
Additional Manufacturer Narrative
Suspect device received on march 17, 2026.Device evaluation completed on march 24, 2026: the product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed that the gel of the breast implant was found to be fragmented with shell deformity.Fragmented gel could alter the appearance of the implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances related to the malfunction were identified as part of this evaluation.Although no conclusion could be reach on the cause of the reported event the product insert data sheet states that the implants must be handled with care as excessive force during implantation might cause gel fracture.(gel fracture is a fissure or fault line in the gel within the implant as a result of excessive applied force).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: no corrective and preventive action (capa) is required now.Reason for device explant and/or reoperation: material deformation.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 BOOST 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: 24879086
• Report Number: 1645337-2026-04386
• Device Sequence Number: 18663153
• Product Code: FTR
• UDI-Device Identifier: 00081317026853
• UDI-Public: (01)00081317026853(17)301111(10)2153029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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 Catalogue Number: SMPB290
• Device Lot Number: 2153029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2006
• 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
• Patient Sex: Female