MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501697
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/11/2025
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.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.A photo of the device was returned for evaluation.The evaluation was completed on nov 2, 2025.Photo evaluation summary: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.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.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.Reason for device explant and/or reoperation: capsular contracture, deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient with saline mentor smooth round moderate profile breast implants experienced bilateral capsular contracture baker grade unknown along with deflation on the left side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent device removal and replacement.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
On nov 19, 2025, the mentor failure analysis lab received the device for evaluation.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned 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.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 23478922
• Report Number: 1645337-2025-12290
• Device Sequence Number: 21389199
• Product Code: FWM
• UDI-Device Identifier: 00081317001331
• UDI-Public: (01)00081317001331(17)091204(10)5653713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2009
• Device Catalogue Number: 3501697
• Device Lot Number: 5653713
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2006
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female