MENTOR Smooth Round High Profile

Description of Event or Problem

It was reported that a 48-year-old Caucasian female patient underwent primary breast augmentation with 460cc MENTOR Smooth Round High Profile and experienced breast implant deflation on her left side postoperatively. 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: As of now there is no information regarding the explant or reoperation. 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)