ASPS Supports FDA Panel Conditional Approval of Silicone Implants

10/15/2003

From: Theresa Hill of the ASPS, 847-228-3349; e-mail: media@plasticsurgery.org; web: http://www.plasticsurgery.org

ARLINGTON HEIGHTS, Ill., Oct. 15 -- 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.