Since their introduction in 1962 by Cronin and Gerow, the safety of silicone breast implants has been studied more closely than many available medical devices. Today, nearly 300,000 breast augmentations and 100,000 breast reconstructions utilize breast implants annually in the United States (US). Despite years of technological advancement in the design and manufacturing, the basic design largely remains the same (1-3).In the early 1980's, just as third-generation silicone implants were being introduced, rising levels of consumer concern became evident in regard to the safety of silicone breast implants. During this time, the FDA's new surveillance system began to identify frequent local complications associated with silicone implants and these devices became classified as higher-risk devices. This new label required manufactures to become responsible for providing data that supported the safety of these devices for patient use (4). The safety of silicone breast implants has been controversial, with >400 reports on various health conditions believe to be in association with breast implants (5).Silicone breast implants were removed from market in 1992 after the FDA concluded that breast implant manufacturers had failed to appropriately address safety concerns. At that time manufacturers were instructed to perform core studies to better assess the safety profiles of silicone breast implants (6-10). Seven years later, the Institute of Medicine (IOM) released a report titled,