MENTOR Smooth Round Moderate Profile

Description of Event or Problem

It was reported that a 70-year-old female patient underwent primary breast augmentation surgery with Mentor SAL SMOOTH RND DIAP 525CC gel implant on the right side, and with unknown size unknown gel implant on the left side on (b)(6) 2010 and subsequently diagnosed with breast cancer.According to the very limited available information, the patient was diagnosed with bilateral breast cancer. Explantation surgery will be performed on (b)(6) 2026.No further information has been provided to date. This case will be re-evaluated should additional information become available.This MedWatch report is for the patient¿s right-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 (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: Right Breast Cancer.D6b Explantation Date: (b)(6) 2026.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).