Unknown Saline Implants

Description of Event or Problem

It was reported that a patient with unspecified Mentor saline breast implants experienced deflation on the right side post-operatively, which was confirmed during a physical exam. 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. Since no lot number was provided, no manufacturing record evaluation review could be performed. 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 catalog/model number was not provided, the (01)GTIN is not available. Reason for device explant and/or reoperation: The patient has not undergone explantation or reoperation at this time. Manufacturer¿s reference number: (b)(4).