BIA-ALCL and SCC
RECURRENCE
No reports of BIA-ALCL or SCC have been reported for patients implanted with MemoryGel Xtra devices in the study. During the conduct of the study, there have been no reports of BIA-ALCL or SCC. However, 1 case of BIA-ALCL was reported in the medical history of a patient undergoing revisional reconstruction with textured, MemoryShape implants before enrollment in the study. The patient completed treatment and and was disease-free prior to entry into the study. As of the most recent follow-up with the patient in 2022, there is no recurrence of BIA-ALCL.