Plastic surgery societies applaud FDA's decision to approve silicone breast implants

November 17, 2006
American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS)

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, M.D., 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.

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.