Cosmetic Use of Sculptra Now FDA Approved

Wednesday, August 12, 2009 10:12 AM

Growing options for facial shaping and rejuvenation.

(Vocus/PRWEB ) August 12, 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 SculptraŽ Aesthetic develop over a period of time, allowing for a natural progression to an improved and more youthful appearance."

SculptraŽ 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 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:

Locate Sculptra Providers

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