A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile breast Implants in Subjects Who are Undergoing primary breast Reconstruction or revision reconstruction ( Athena)
I am proud to be a principle investigator in this study. For many years the FDA has limited the size of breast implants to 800 cc. Unfortunately even the 800 cc were not adequate for many women. This meant that they were required to have a reduction on the opposite breast or were left with a reconstruction which did not fill out their chest wall. Finally we have access to larger implants ( up to 1445 cc) for both primary and revision breast reconstruction patients. The implants have to be fully evaluated before the FDA approves them for use by any plastic surgeon and so patients are being enrolled in a study. The patients who are enrolled will be followed for ten years and will periodically undergo MRI’s to evaluate the status of the implants. This is an exciting advance for women and breast reconstruction and I am pleased to be a part of it!