MENTOR Smooth Round Moderate Plus Profile

Description of Event or Problem

It was reported that a patient underwent a breast augmentation revision procedure with a MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis that deflated post implantation. Deflation of the patient¿s left breast prosthesis was reported. Additionally, the patient developed Baker Grade III capsular contracture in her left breast. The issues were diagnosed during an office visit. As a result, the patient underwent bilateral explantation and replacement with MENTOR MemoryGel BOOST Breast Implant gel 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 (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: Breast prosthesis deflation, capsular contracture. 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. Manufacturer¿s reference number: (b)(4).