The filler Sculptra® was at one time considered an important agent in managing facial fat loss in HIV+ patients. Prior to FDA approval, it was used in a clandestine manner. In clinical trials evaluating this agent for correction of fat loss in HIV+ patients although the study patients were for the most part satisfied, up to 50% of the injected individuals developed some degree of lumpiness in the treated areas. Furthermore, these lumps are often far from invisible. Nevertheless, Sculptra® received rapid track compassionate release approval from the FDA for use in patients with HIV. The panelists on the General and Plastic Surgery Device panel were strongly unanimous in limiting approval only for patients with HIV. At the FDA hearing, not one histologic slide showing the fate of Sculptra upon implantation was shown. Again, how can an agent gain approval without scientific data supporting its application?
According to the European literature the consequences of Sculptra® in the normal host has been very problematic (foreign body granulomas, infections, etc.). I have biopsied many patients after Sculptra and what I find is no collagen production but rather a reaction similar to that surrounding a thorn in your foot.
Nevertheless, the lay press, medical conferences and internet began to promote this substance for soft tissue augmentation in HIV negative patients. Prospective studies for the use of this agent in individuals with normal immune functioning have been completed in the United States and now it is approved for use in everyone. But please don't go anywhere near it
In 2000, at the World Congress of Dermatology in Paris, Pierre Andre reported cystic, nodular, and granulomatous lesions when this agent was used in individuals with normal immune functioning (non-HIV+ patients). Additionally, long-term allergic reactions have since been described, which are very difficult to manage. In another report concerning its aesthetic use in 100 patients with normal immune functioning, 20% of the treated individuals experienced significant adverse reactions. Obviously, this product is not immunologically inert as the manufacturer stated. Foreign body granulomas are being seen with this agent in HIV-positive as well as immunocompetent patients.
While the manufacturer as well as investigators claim this product produces neocollagenesis or new collagen this is not what is seen under the microscope. On biopsy one sees a severe immune reaction to the product as described. As the father of the the field of soft tissue augmentation I would have to call Sculptra a bad seed!
Arnold W. Klein, MD
Professor of Medicine and Dermatology
Klein Chair in Dermatology UCLA
Consultant to the General and Plastic Surgery Devices Panel of the FDA firstname.lastname@example.org
"The Most Innovative & Famous Cosmetic Dermatologist in the World!”
- Beverly Hills Times Magazine, Spring 2011 Beauty Issuel