Although silicone implants were removed from the market during the 1990’s over safety concerns, questions about their reliability have been answered through years of research and multiple studies. Over a 14 year period, the FDA and implant manufacturers performed various studies on silicone implants; they also followed women who had received the implants. As no problems were ever attributed to the silicone, the FDA ruled silicone implants to be completely safe. They were re-approved for use in 2006, for women over the age of 22 (when breast development is considered complete). Special approval can be given to younger women who need correction of developmental abnormalities or breast reconstruction.
In 1962, a Houston woman was the first to receive silicone implants. Since that time, both the outer shell and the silicone filling has greatly improved. Changes have been made in the shell, now proven to decrease chances of a silicone “bleed” (the amount of silicone shed in the body). These changes explain why recent studies have shown there are higher levels of silicone in canned infant formula than there are in the breast milk of patients augmented with silicone implants. Vitenas Cosmetic Surgery has been using silicone implants since their initial approval, and since their reintroduction, has developed an exceptional affinity for silicone implant placement. Dr. Vitenas currently uses Natrelle silicone implants, made by Allergan, a fourth generation silicone implant. They contain a cohesive silicone gel in a thick, low-bleed outer shell, and have a lifetime implant warranty.