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: breast cancer and rupture. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a female patient underwent a primary breast reconstruction with mentor memorygel breast implants (300cc on the left side; 200cc on the right side). The patient reported that she was diagnosed with right-sided breast cancer on (b)(6) 2020. She stated that she would have to go into radiation but her physician does not believe that her implants could handle the treatment. She also stated that an mri on (b)(6) 2020 confirmed bilateral intracapsular rupture. As a result, the patient's devices were scheduled for removal on (b)(6) 2020. This report is for the patient's right-sided device.
Patient Sequence No: 1, Text Type: D, B5