What are the new conditions of approval?
There are several conditions that the FDA has mandated with approval of silicone gel implants that are different from saline implants: • The augmentation patient must be at least 22 years of age. See Patient Labeling for more information about the process of Informed Decision that is also a new requirement. • The FDA has determined that all physicians who use MemoryGel® products will have ongoing Device Tracking obligations. You may download Device Tracking forms from this website. • All physicians are required to take a Device Access Education course. • Mentor will conduct a Post-approval Study to further the long-term science on breast implants. This study will begin 90 days after approval.
