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)(6).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with a 375cc mentor memorygel breast implant and experienced postoperative left-sided grade iii capsular contracture. The diagnosis was confirmed by a healthcare professional. As a result, the patient underwent removal and replacement with unspecified breast implants on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5