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.
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.
The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. ASAPS active-member plastic surgeons are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org.
The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. With more than 6,000 members, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.
Minas T Chrysopoulo, MD
Board certified plastic surgeon specializing in microsurgical breast reconstruction after mastectomy including the DIEP flap operation.
Plastic, Reconstructive & Microsurgical Associates (PRMA) of South Texas,
San Antonio, TX
(210) 692-1181, Toll Free (800) 692-5565