Silicon Breast Implants

Plastic Surgery Societies Applaud the FDA’s Decision to Approve Silicone Breast Implants
For Immediate Release: November 17, 2006
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.
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 more than 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. www.plasticsurgery.org

Breast Implant Update April 13, 2005
Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants Be Approved With Conditions
For Immediate Release: April 13, 2005
GAITHERSBURG, MD - The FDA advisory panel's 7-2 vote today to recommend to the FDA that Mentor's silicone breast implants be approved with conditions is applauded by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), the two largest plastic surgery membership organizations. This recommendation comes 13 years after the FDA restricted access to the silicone implants because of safety concerns. "We are pleased that the panel based its decision on scientific evidence, not on special interests, emotion or anecdotes," said James Wells, MD, ASPS past president. The comments by Josh Levine, Mentor's CEO, during his summation confirm Mentor's long-term commitment to safety. This should go a long way to assure the FDA and the public that the panel's recommendation is prudent and sound.
ASPS and ASAPS are optimistic that the FDA will follow the panel's recommendation. "By doing so, Mentor can move forward to reintroduce silicone implants as an option for American women. Organized plastic surgery is enthusiastic about working with the manufacturer to ensure women's health and safety," said ASAPS President-Elect Mark Jewell, MD. "Plastic surgeons are committed to helping women make informed choices about their health care based on all the available and accurate information about these devices."
Both societies are prepared to work with the FDA and Mentor to fulfill the conditions which include physician education, patient education, a registry, and a commitment from the manufacturers for continued data collection. Prior to today's decision, ASPS and ASAPS have taken a leadership role in physician education, patient informed consent, and development of a registry.
On April 12, the FDA advisory panel issued in a 5-4 vote a non-approvable recommendation to Inamed's application for approval of its silicone breast implants. The panel encouraged Inamed to address its remaining concerns and then request panel re-review of its application for approval. "We are hopeful that a similar favorable recommendation will be issued in the near future to Inamed if it can satisfy the FDA's remaining concerns," said Dr. Jewell.
To that end, the two societies believe continued data collection and study of the procedure and device are essential, and they are committed to being active participants in post-market monitoring of the implants.
In addition, ASPS and ASAPS will continue to offer assistance to the manufacturers with additional conditions set forth by the FDA related to physician and patient education. At the forefront of their ongoing education campaign is the recently launched joint Web site www.breastimplantsafety.org. This will be the authoritative Web site for both saline and silicone breast implants and offer objective and science-based information.
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. 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 a mastectomy.
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. With more than 5,000 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. www.plasticsurgery.org.
The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. Since 1967, ASAPS has been the authoritative source in cosmetic surgery education and research. ASAPS� 2,200 plastic surgeons are elected to membership and are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org.