There is great news for patients whom have had breast reconstruction, but 800 cc is not enough projection or large enough to reach the size they were hoping for. There are now 8 sites where patients can enroll in the Mentor "Large Ultra High Silicone Implant Study". Implants as large as 1445 are available. We have performed secondary revisions on multiple patients that needed a larger implant to fit their body and get the projection needed. Finally we have a solution for patients unhappy with their reconstruction at 800cc.Mentor logo IRVINE, Calif., Feb. 16, 2016 /PRNewswire/ -- Mentor Worldwide LLC, a global leader in breast reconstruction, today announced that it has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its ATHENA clinical trial. The trial is designed to demonstrate the safety and effectiveness of new sizes of MENTOR® MemoryGel® Breast Implants for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed mastectomy tissue. "There is a clinical need for breast implants larger than those currently available in the United States," said Dr. David Caplin, Board-certified Plastic Surgeon and President of Parkcrest Plastic Surgery Associates in St. Louis, Missouri.[1] "The size options for breast implants today are not adequate, especially when performing reconstructive surgery on large-breasted women diagnosed with breast cancer." The largest implants currently available in the U.S. are 800cc. Mentor expects to begin enrolling primary and revisionary breast reconstruction patients in the ATHENA clinical trial by April 2016. The ATHENA trial plans to enroll 600 patients at up to 35 sites nationwide and test implants manufactured using the same shell and gel as Mentor MemoryGel® Breast Implants. They will range in size from 750cc to 1445cc. "Obtaining IDE approval for the ATHENA clinical trial and the investigation of these larger implant sizes as part of the Mentor® MemoryGel® Breast Implant product family underscore our commitment to reconstruction," said Luis Davila, Vice President, Research & Development, Mentor Worldwide LLC. "We hope this study will contribute to a broader patient access to reconstruction surgery and address a long-standing patient need." As the leader in breast reconstruction, Mentor has launched multiple reconstruction solutions over the past 18 months, including new MemoryShape® Breast Implant styles and the ARTOURA™ Breast Tissue Expander. Mentor Breast Implants are backed by substantial clinical data demonstrating safety and effectiveness in primary augmentation, reconstruction and revision patients.[2][1] Dr. Caplin is a paid consultant to Mentor Worldwide LLC. [2] Mentor Core and Continued Access studies for round and shaped breast implants.