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ASPS Supports FDA Panel Conditional Approval of Silicone Implants
10/15/03 5:24:00
PM To: National Desk, Health Reporter
Contact: Theresa Hill of
the ASPS, 847-228-3349; e-mail: media@plasticsurgery.org; ARLINGTON HEIGHTS, Ill., Oct. 15
/U.S. Newswire/ -- The American Society of Plastic Surgeons (ASPS) supports
the U.S. Food and Drug Administration (FDA) advisory panel's recommendation
today to approve silicone breast implants conditionally and commends the panelists
for their dedication to the safety and best interests of patients. "Based on the data presented
at the FDA panel hearings Oct. 14 and 15, the panel approved the product with
conditions," said ASPS President James Wells, MD. "As plastic surgeons, our
utmost concern remains the safety and well being of our patients. The ASPS developed
a patient education brochure to fully inform patients about risks and complications
of this surgery. It is available to patients from their board-certified plastic
surgeon or by visiting http://www.plasticsurgery.org." The ASPS believes that important
components of patient safety for women seeking breast augmentation include patients
being fully informed about the benefits and risks of the procedure, continued
data collection and study of the procedure and device. The ASPS National Breast
Implant Registry (NaBIR), founded in 2000, collects and analyzes data regarding
breast surgery. The ASPS applauds the FDA panel's condition to require a national
breast registry and is prepared to take the necessary steps to partner with
the FDA and manufacturer to make NaBIR the registry of choice. Nearly 237,000 women chose breast
augmentations in 2002, the vast majority of which were saline, according to
the ASPS. Breast augmentation remains an option for women interested in the
procedure. The clinical experience of ASPS members over the past 35 years with
breast augmentation surgery shows an excellent track record and the demand for
breast augmentation has grown steadily (593 percent) since 1992. In a 2002 report
published in Plastic and Reconstructive Surgery, more than 90 percent of women
were satisfied with their breast augmentation surgery and their resulting body
image two years post-operatively. The American Society of Plastic Surgeons
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. Women interested in breast
augmentation should research the procedure thoroughly. The society's web site
http://www.plasticsurgery.org contains accurate information about many plastic
surgery procedures. For more information or referrals to an ASPS plastic surgeon,
call 888-4-PLASTIC (888-475-2784). ASPS, founded in 1931, is the largest
plastic surgery organization in the world and the foremost authority on cosmetic
and reconstructive plastic surgery. ASPS represents physicians certified by
The American Board of Plastic Surgery (ABPS) or The Royal College of Physicians
and Surgeons of Canada. -0- /© 2003 U.S. Newswire 202-347-2770/