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 a caucasian female patient who underwent primary breast reconstruction surgery with a 700cc mentor memorygel breast implant experienced anxiety, depression, induced diabetes, fatty liver, joint pain, arthritis, left implant sitting on nerve, pain, brain fog, insomnia, inflammation, underarm pain, fatigue post procedure. Patient had a surgical procedure on an unknown date to remove lymph nodes but still has pain under her arm. 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