FDA’s Initial Comments Still Find No Link Between Silicone Implants and Systemic Disease
New York, NY – Silicone breast implants have been scrutinized more than any medical device, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) stated today. Both plastic surgery societies, which will be represented at the upcoming hearings of the U.S. Food and Drug Administration (FDA) Advisory Panel in Gaithersburg, MD, April 11-13, 2005, urge the FDA to conduct a fair hearing based on sound science, not emotion.
ASAPS and ASPS have confidence that the FDA will make its decision based on the best interests of patients, not on junk science or personal anecdotes. Plastic surgeons are committed to helping women make informed choices about their health care based on all available and accurate information about these devices.
“All surgical procedures are about informed patient choice,” said Mark Jewell, MD, ASAPS President-Elect. “Our primary concerns are patient safety and satisfaction. What is ultimately important to every plastic surgeon is that medical devices used for breast surgery are safe.”
“Breast implants, as with any other medical device, do not last a lifetime,” said James Wells, MD, ASPS past president. “No medical device is flawless and neither are silicone implants or saline, for that matter. The FDA’s initial findings which are critical of the implants tell only part of the story in its recently posted comments. These observations are contained in nearly 200 pages and certainly need to examined, however, they need to be considered in context of the entire breadth of epidemiologic research and scientific study. If the science supports the safety and effectiveness of these devices, women deserve to have silicone implants as a choice.”
An increasing number of women are choosing breast augmentation to enhance their appearance. According to ASAPS, nearly 335,000 women chose breast augmentation in 2004, the vast majority with saline implants, the only option available to most of them.
More than 62,000 women had breast reconstruction in 2004, according to ASPS. Breast reconstruction has been proven in numerous studies to have many psychological and physical benefits for women who have undergone mastectomy.
Plastic surgeons support 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.
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 90 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.