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: capsular contracture. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a female patient who underwent breast augmentation with a 450cc mentor memorygel breast implant on an unknown date experienced capsular contracture (baker grade unknown) post procedure. As a result, bilateral implant replacement on an unknown date was performed. No additional details are available at this time. If additional details are made available in the future, then a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5