|Arlington Heights, Ill. (November 17, 2006) – The American Society for Aesthetic Plastic Surgery and The American Society of Plastic Surgeons, the two largest plastic surgery membership organizations, applaud the FDA's decision today to approve (manufacturer's) silicone breast implants and return these devices to the U.S. market. This decision comes 14 years after the FDA restricted access to the silicone implants because of safety concerns.|
“This is a great day for American women and the plastic surgeons who care for them,” said Roxanne Guy, MD, ASPS president. “Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care.”
Today's FDA decision follows a lengthy process in which the agency sent “approvable with conditions” letters to the two silicone breast implant manufacturers in the second half of 2005. The approvable letter stipulated a number of conditions that the manufacturers needed to satisfy in order to receive FDA final approval to market and sell silicone breast implants in the United States. These letters came after an FDA advisory panel hearing in April 2005, in which the panel heard more than 20 hours of data presentations from the manufacturers and public comment.
“Plastic surgeons are committed to patient safety and education,” said James Stuzin, MD, ASAPS president. “It is clear that the agency has carefully evaluated the data presented by the manufacturers, as well as the testimony of physicians, patients and advocacy groups and has made a thoughtful decision to give our patients the access to silicone gel breast implants that women in 60 countries around the world have.”
The specialty of plastic surgery supports a woman's right to make informed personal choices about her health care based on all the available and accurate information about cosmetic plastic surgery, breast augmentation and breast reconstruction. Cosmetic plastic surgery is serious surgery. It requires a complete medical consultation with a plastic surgeon certified by the American Board of Plastic Surgery who will fully inform a potential patient about the risks and benefits of surgery.
Approximately 300,000 women chose breast augmentation in 2005, according to ASAPS and ASPS statistics. Nearly 58,000 women had breast reconstruction in 2005, according to ASPS. Both breast augmentation and reconstruction have been proven in numerous studies to have psychological and physical benefits for women who choose these procedures.
The ASPS and ASAPS will continue to offer their assistance to the manufacturers for the conditions set forth by the FDA related to physician and patient education. One comprehensive example of this assistance is a joint Web site, breastimplantsafety.org , which offers objective and science based information regarding saline and silicone breast implants.