Cosmetic Use of Sculptra Now FDA Approved

New York, NY (Vocus) August 13, 2009

Sculptra, a poly-L-lactic acid filler previously approved for loss of facial fat in HIV positive individuals, is now approved for cosmetic use, to add volume and fullness to facial features and contours. "Sculptra offers a very different approach to treating the aging face," says Coalition leader Ira D. Papel, M.D., Baltimore, MD. "This cosmetic injection can deliver more diffuse, regional improvement in the soft tissue folds of the face. The results from Sculptra® Aesthetic develop over a period of time, allowing for a natural progression to an improved and more youthful appearance."

Sculptra® Aesthetic generally requires a series of injections, at three or more week intervals, for up to four treatment sessions. In clinical trials patients were followed for 12 months after their series of injections. It is reported that treatment outcomes were maintained up to 25 months after the last treatment session. Short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling. Other adverse events reported during the 25-month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own.

"Clinical trials for Sculptra® Aesthetic treated the nasolabial folds - the lines from the nose to the mouth - the same area that is commonly treated with hyaluronic acid dermal fillers such as Juvederm or Restylane," says Coalition leader Brian Biesman, M.D., Nashville, TN. "But the results are very different. The outcomes from a Restylane injection are immediately visible, and treat the area specifically where the substance is placed. The Sculptra results appear over time and are somewhat more diffuse. Metaphorically it is the difference between placing a graft specifically and instantly where you want results, vs. spreading a shower of seeds and waiting as those seeds begin to grow."

"The new additions, and very different injections technologies to treat facial aging or improve appearance require that consumers choose a very well-trained, experienced physician if they are considering injections," says Coalition leader Mark Codner, M.D., of Atlanta, GA. "The message of 'Doctor. Brand. Safety' is something easy to remember and important to follow. Choose your doctor carefully, elect only FDA approved brands and ask specifically about the benefits and potential adverse events you may experience. Most of all, make sure your goals include preserving your safety as specifically as you wish to improve your appearance."

The Coalition offers consumers extensive, easy to use resources including a cosmetic injection planner with all the questions you must ask your provider at http://www.injectablesafety.org . In addition, an up-to-date listing of the status of investigational and approved cosmetic injection drugs and devices is available on the site, as well as pictures that will help consumers identify a genuine brand. In addition consumers are urged to ask and consider these simple questions before considering any cosmetic injectable procedure:

• Doctor: Is the injectable recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility? Has the doctor examined the prospective patient before recommending treatment?
• Brand: Is the injectable recommended approved by the U.S. FDA, and by equivalent agencies in the country of origin, for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval?
• Safety: Is the setting a proper medically-equipped office, with safety and sterilization procedures? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?

About Us
The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, the American Society of Ophthalmic Plastic and Reconstructive Surgery, the American Society for Dermatologic Surgery, American Society of Plastic Surgeons, the International Society for Aesthetic Plastic Surgery, the International Federation of Facial Plastic and Reconstructive Surgery Societies, and the Canadian Society for Aesthetic Plastic Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.

###