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. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: n/a. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that (b)(6) year-old caucasian female who underwent primary breast augmentation with a 275cc mentor memorygel breast implant experienced right sided baker grade iv capsular contracture post procedure. The breast was firm, hard, less rounded, painful, tight, warm, and moving up the chest. At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Patient Sequence No: 1, Text Type: D, B5