MENTOR Smooth Round Moderate Profile

Description of Event or Problem

It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR Smooth Round Moderate Profile saline breast prosthesis that deflated post implantation. Deflation of the patient¿s right breast prosthesis was reported. As a result, the patient underwent bilateral explantation and replacement with MENTOR Smooth Round Moderate Plus Profile saline breast prostheses.

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: Breast prosthesis deflation.D4: UDI: As the serial number for the device involved in the event was not provided, 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).