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

Catalog Number	3501501BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of a 150cc mentor memorygel breast implant prosthesis.Post-operatively, the patient reported experiencing right breast capsular contracture (baker grade rating was not provided) which was identified using ultrasound imaging.A consultation with a medical professional has been conducted.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
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: the patient has not undergone explantation or reoperation at this time.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 december 09, 2025, mentor received the following additional information: a corrected patient age was provided.Patient age at the time of event: 40 years old.The patient was diagnosed with bilateral baker grade iii capsular contracture and the explantation surgery was rescheduled.Date of explantation: (b)(6) 2026.As an event for the contralateral side was indicated, another file was generated to document the event.This report is for the right breast prosthesis.On december 16, 2025, mentor was notified that the patient will undergo bilateral exchange with mentor gel implants during the revision surgery.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 09, 2025, mentor received the following additional information: race: white.Baker grade rating: iii.The patient has an explantation date reported as (b)(6) 2026.Date of explantation: (b)(6) 2026.Reason for device explant and/or reoperation: capsular contracture.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 07, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection of the device.During visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 05, 2026, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: 23319029
• Report Number: 1645337-2025-11632
• Device Sequence Number: 5135375
• Product Code: FTR
• UDI-Device Identifier: 00081317000228
• UDI-Public: (01)00081317000228(17)291107(10)2011097
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3501501BC
• Device Lot Number: 2011097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/09/2025; 12/09/2025; 02/05/2026; 03/07/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/03/2025; 12/30/2025; 02/26/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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; Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White