Unknown Mentor Saline Implants

Description of Event or Problem

A female patient who underwent Breast Augmentation Revision with an unknown MENTOR saline Breast implant experienced right sided deflation post operation. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.

Additional Manufacturer Narrative

At the time of this report, Mentor 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. Since no lot number was provided, no manufacturing record evaluation review could be performed. Reason for device explant and/or reoperation: NA. 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. D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available. Manufacturer¿s reference number: (b)(4).