Unknown Saline Implants

Description of Event or Problem

It was reported that a 47-year-old female patient underwent primary breast augmentation with unknown size Unknown Saline Implants and experienced breast implant deflation, and Capsular Contracture; Baker Grade unknown on her left side. The patient underwent bilateral replacement surgery with catalog number SMPB320; serial number (b)(6) on the right side, and with catalog number SMPB320; serial number (b)(6) on the left side on (b)(6) 2026.

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. Since no lot number was provided, no manufacturing record evaluation could be performed. Reason for device explant and/or reoperation: Left Deflation, and Capsular Contracture; Baker Grade unknown D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available. D4: UDI: As the lot, serial number, and corresponding expiration date 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).