The Food and Drug Administration (FDA) has approved the use of silicone gel implants for women seeking breast augmentation. The decision to lift the 14 year ban on silicone gel implants for cosmetic use followed extensive research on its safety profile. Silicone gel implants have been available to women undergoing breast reconstruction and to a subset of women seeking breast augmentation who met specific criteria outlined by the FDA. One of the requirements of the recent approval is that a woman seeking breast augmentation for cosmetic purposes be at least 22 years old.

Last year over 290,000 women had breast augmentation in the United States. The vast majority of these women had saline (saltwater) implants. In other countries in which both saline and silicone gel implants are available, silicone implants make up almost 90% of the market. Many plastic surgeons anticipate a significant rise in the number of silicone gel implants used for breast augmentation. "Already I am experiencing an increased interest in silicone gel implants since the approval was first announced,' notes Louis DeLuca, M.D., a Boca Raton plastic surgeon. Having participated in the silicone gel implant research study that ultimately resulted in the ban on silicone gel implants being lifted, Dr. DeLuca echoes the sentiment of many plastic surgeons that "gladly women now have another option available to them when choosing to undergo breast augmentation. Many of my patients expressed an interest in silicone gel implants because they feel more natural, however, the previous ban did not allow them the opportunity to consider silicone gel implants when pursuing their breast augmentation."

The FDA has outlined specific requirements regarding silicone gel implants that the implant manufacturers and plastic surgeons performing breast augmentation must follow. These requirements are important in maintaining an ongoing assessment of the safety of silicone gel implants and providing patients with enough information to make informed decisions.