FDA Panel Conditional Approval of Silicone Breast Implants
For immediate Release, October 15, 2003
Arlington Heights,
Ill. The American Society of Plastic Surgeons (ASPS) supports the US 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-plastic surgeon or
by visiting the ASPS website.
The ASPS believes that the 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 augmentation 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%) 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.(...)
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