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Press Release: February 5, 2003 American Society for Aesthetic Plastic Surgery

RESTYLANE: The Next "Must Have" Injectable?

New York, NY (February 5, 2003) - The list of cosmetic soft tissue fillers on the market and in the pipeline worldwide is growing rapidly. Many have been introduced with great fanfare; relatively few stand the test of regulatory or peer review - as well as the test of time. Currently, the Food and Drug Administration (FDA) is considering cosmetic approval of hyaluronic acid, marketed under the name Restylane, which has been used to fill wrinkles in Canada and Europe, but has not yet been approved for cosmetic use in the United States. Restylane is a crystal clear gel used for soft-tissue filling of lips, facial wrinkles and facial folds. The hyaluronic acid in Restylane, although biosynthetically produced, is almost identical to that existing naturally in all living organisms. Hyaluronic acid is a key structural component of the skin, creating volume and shape, and acting as a lubricant and shock absorber. Hyaluronic acid concentrations throughout the human body decline with age, causing undesirable changes in the skin.

Hyaluronic acid was first used commercially in 1942. In the last two decades the therapeutic and aesthetic uses have expanded. In the United States, hyaluronic acid has been used in eye surgery, as a "shock absorber" to protect the retina, and has been proven effective in lubricating arthritic joints. "Plastic surgeons are constantly searching for the 'perfect' soft tissue filler - a long-lasting substance that effectively fills wrinkles, folds and plumps up the lips, but has little or no downtime for the patient and causes no allergic reactions. To date, Restylane is the closest we have come to that ideal," says Gaston Schwartz, MD, a Canadian plastic surgeon and member of the American Society for Aesthetic Plastic Surgery (ASAPS), who has been using Restylane since its approval in Canada in the fall of 1998.

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Jay Burns, MD, chair of the ASAPS Facial Surgery Committee, notes that the efficacy of Restylane is dependant on many variables. "While clinical trials appear to demonstrate that Restylane may be effective for up to one year for treatment of wrinkles and six months for lip augmentation, results are not the same in every case. Injection technique may be a factor, as well as individual patient variables." Dr. Burns adds that the anticipated FDA approval will facilitate more meaningful clinical evaluation of Restylane's benefits. "When plastic surgeons have the opportunity to gather data based on large numbers of patients over an extended period of time, we will have a much better idea of this product's 'niche' within the entire range of soft tissue fillers," he says.

There have been anecdotal reports of complications in connection with the use of hyaluronic acid, but doctors say the incidence of problems associated with the newest products is very low. Nevertheless, even if Restylane gains FDA approval, some physicians may hesitate to use it until they are convinced that the benefits outweigh any possible risks.

According to statistics from the American Society for Aesthetic Plastic Surgery (ASAPS), nearly 8.5 million Americans underwent cosmetic procedures, both surgical and nonsurgical, in 2001. The greatest increase in numbers was in nonsurgical procedures such as injectables.

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The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of plastic surgeons certified by the American Board of Plastic Surgery (ABPS) who specialize in cosmetic surgery of the face and the entire body.

Toll-free referral line: 1-888-272-7711. Web site: www.surgery.org.

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