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

Catalog Number	SMHX500
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/08/2025
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: migration.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: pc-001915488.
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of a 500cc mentor memorygel xtra breast implant prosthesis.Post-operatively, the patient was diagnosed with bilateral implant displacement and the patient desired an increase in size/volume of the left side to match the right.As a result, the patient underwent bilateral capsulorrhaphy, unilateral left-sided exchange with a mentor gel implant, and right-sided implant removal and reimplantation (b)(6) 2025.Furthermore, during the surgery, a ruptured left implant was discovered.There were no reported procedural delays or patient consequences due to the findings.This report is for the left breast prosthesis.
Additional Manufacturer Narrative
On august 12, 2025, the mentor analysis lab received the suspect medical device for evaluation.On august 19, 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor then conducted visual inspection and microscopic examination of the device.Visual analysis of the returned device determined that the breast implant was found to be ruptured and received in two (2) parts.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the posterior aspect, measuring approximately less than 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.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: 22665641
• Report Number: 1645337-2025-08303
• Device Sequence Number: 14378166
• Product Code: FTR
• UDI-Device Identifier: 10081317027888
• UDI-Public: (01)10081317027888(17)260422(10)9567914
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 04/22/2026
• Device Catalogue Number: SMHX500
• Device Lot Number: 9567914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White