Sculptra: FDA Approval For Facial Wasting
New York, NY (August 6, 2004) – Sculptra, recently approved by the Food and Drug Administration (FDA) for treatment of facial wasting in HIV patients, is being viewed by plastic surgeons as a potentially exciting cosmetic treatment to restore facial volume diminished as a result of aging. Although not yet FDA-approved for cosmetic uses in healthy patients, physicians can now use Sculptra "off-label" for filling wrinkles and depressions as well as for cosmetic facial contouring.
“FDA approval of Sculptra is, first, a very important advancement in helping HIV patients live more normal and satisfying lives,” says Peter B. Fodor, MD, president of the American Society for Aesthetic Plastic Surgery (ASAPS). “For cosmetic patients, the benefits of Sculptra in achieving long-lasting restoration of facial volume have yet to be confirmed by clinical trials in the U.S. however, the product is approved in Europe, where physicians have been using it as a wrinkle-filler for five years with reportedly good results.”
The manufacturer, Aventis (a subsidiary of Dermik Laboratories, Berwyn, PA) says that cosmetic trials in the U.S. are planned for this year, and it will seek FDA approval for Sculptra as a wrinkle treatment.
Sculptra, marketed in Europe as New-Fill, has been used on more than 150,000 people in over 30 countries. Its main ingredient is poly-L-lactic acid, used for more than 20 years as a component of absorbable sutures and sustained-release injectable medications. Poly-L-lactic acid appears to stimulate the skin's dermal layer to produce more collagen and is effective not only in adding volume but also in shaping and contouring the face. Since it is produced from a polymer synthetically derived from natural components there is no need to test patients for allergic reaction. Possible side effects include bruising, redness, lumps and nodules, or granulomas.
Brian Kinney, MD, member of the ASAPS Nonsurgical Procedures Committee, notes that the duration of results from Sculptra is dependent on individual patient variables. “While clinical trials appear to demonstrate that after a series of injections the product may be effective for up to two years for treatment on patients with facial wasting, results are not the same in every case. Patients may need to have touch-up treatments.” .
Dr. Fodor adds that FDA approval will facilitate more meaningful clinical evaluation of the benefits and possible risks of Sculptra. “When plastic surgeons have the opportunity to gather data on the cosmetic applications of Sculptra, based on large numbers of patients over an extended period of time, we will have a much better idea of where this product fits within the entire range of soft tissue fillers,” he says. Sculptra is expected to be on the U.S. market by the third quarter 2004.
According to ASAPS statistics nearly 8.3 million Americans underwent cosmetic procedures, both surgical and nonsurgical, in 2003. The greatest increase in the past five years has been in nonsurgical procedures.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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