Sculptra Aesthetic Receives FDA-Approval

    CHICAGO, IL, October 15, 2009 /24-7PressRelease/ -- When the FDA approved Sculptra Aesthetic for use in cosmetic restoration of facial volume patients have lost due to aging, it was merely putting its stamp on what was becoming a common practice: the general use of Sculptra (injectable poly-L-lactic acid) that had been approved to help restore facial volume in HIV-positive patients. The move for approval by manufacturer sanofi Aventis was in response to the growing potential of the injectable treatment market in the United States, which has grown dramatically in recent years. BOTOX Cosmetic injections have grown by nearly 600% since 2000, and injectable filler treatments have grown by almost 150%.

Sculptra Aesthetic has one major advantage over many of its competitors: long-lived results. Where many facial fillers give results that last about six months on the outside, Sculptra promises results that may last for up to two years. But Sculptra may not be the next BOTOX Cosmetic or Restylane. It faces several obstacles that may limit its popularity.

A Steep Learning Curve
Unlike many injectables that are interchangeable with slight modifications for thickness or texture, Sculptra requires plastic surgeons to learn a whole new technique for its use. The prescribing information for Sculptra Aesthetic includes nearly two full pages of instructions on how to inject the compound. This includes several warnings directed at doctors to follow specific injection patterns, not overcorrect, and avoid blood vessels. The prescribing information also includes extensive instructions for post-operative care that doctors. Many doctors have found Sculptra to be a difficult product to use, and although it has been available for years, its adoption remains small.

Possible Serious Side Effects
The most common serious side effect of Sculptra injections is the creation of hard nodules or papules in the treatment site. In approval studies, about 17% of patients experienced nodules or papules or both. Nodules are growths on the body that can be seen and felt. Some of them become very hard. Papules are like nodules but are below the skin and not visible. In studies, all patients with nodules for whom outcomes were known all experienced spontaneous improvement, but it is not clear that this will continue to be the case in the larger patient population.

Whether nodules resolve spontaneously or not, the appearance of visible growths in treatment areas like the face or hands with a rate of 17% seems a significant obstacle to the widespread adoption of this injectable treatment.

Unconvincing Results
Currently, Sculptra reviews are marginally favorable. One independent ratings site shows 56% of people recommending the treatment. Partly because doctors are encouraged to undercorrect at first, partly because results are slow in developing, and partly because like a nonsurgical treatments it does offer at best moderate results, even people who recommend Sculptra treatments give it a cautious endorsement, compared to many of the people who rate it unfavorably who are vehement in their negative comments. Unless Sculptra builds up a fan base quickly, it might not become as large a seller as its marketers hope.

If you would like learn more about the potential benefits and shortcomings of Sculptra or other injectable treatments, please visit the website of Chicago-area plastic surgeon Dr. Otto J. Placik.

Website: http://www.bodysculptor.com

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