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

Catalog Number	SHPX595
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent a breast augmentation revision procedure with a mentor memorygel xtra breast implant 595cc gel breast prosthesis was dissatisfied with the size of the breast implant.The patient thought the implant was too small.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a.H6 health effect - clinical code e2402: patient dissatisfaction with procedure outcome.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).
Additional Manufacturer Narrative
On 15-jul-2025, mentor received additional information about the event.The patient underwent explantation on (b)(6) 2025.Reason for device explant and/or reoperation: patient was dissatisfied with the size of her implant.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2025, mentor received additional information about the event.It was reported that patient developed an infection in her left breast and also that the left breast prosthesis ruptured and those were the reason for explantation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 27-oct-2025, mentor received additional information about the event: an updated explantation date ((b)(6) 2025) was reported.The suspect medical device was discarded following explant surgery.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 11-feb-2026, mentor completed its investigation on the suspect medical device.The investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Device evaluation summary: according to the information received, the patient experienced a rupture in the breast implant and the patient developed an infection.Upon visual evaluation of the image provided in the complaint, the implant was observed to be ruptured.As the product involved in this complaint was discarded, the device could not be analyzed according to our procedures.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the implant is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.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.Additional complaint information monitoring for potential safety signals will be 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: 22431613
• Report Number: 1645337-2025-07455
• Device Sequence Number: 14234762
• Product Code: FTR
• UDI-Device Identifier: 00081317025337
• UDI-Public: (01)00081317025337(17)300315(10)2055384
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SHPX595
• Device Lot Number: 2055384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 07/16/2025; 10/27/2025; 02/11/2026
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/04/2025; 08/14/2025; 11/15/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White