MENTOR Smooth Round Moderate Profile

Description of Event or Problem

It was reported that a 48-year-old female patient underwent revision breast augmentation with a 525cc MENTOR Smooth Round Moderate Profile on both sides and was presented with right side breast deflation postoperatively. On (b)(6) 2026, Mentor became aware that the patient also suffered left side capsular contracture; baker grade II/III in addition to right side deflation, and underwent bilateral replacement surgery with catalog number 3501660D; serial number (b)(6) on the left side, and with catalog number 3501660D; serial number (b)(6) on the right side on (b)(6) 2026.This MedWatch report is for the patient¿s left-sided device.

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 is in progress. Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: Left capsular contracture; baker grade II/III.D4: UDI: The expiration date is currently not verified. Therefore, the full UDI is currently not available.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).