beverly Hills, CA
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Sculptra and Radiesse-what kind of fool are you?
November 18, 2011 10:58 PM
The filler Sculptra®, or New-Fill?, 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.
The filler Sculptra®, or New-Fill?, 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? Subsequently Sculptra was approved for use in HIV- patients again with data that did not support its application or problems
According to the European literature the consequences of Sculptra® in the normal host has been very problematic (foreign body granulomas, infections, etc.)
Here is a photograph of a patient who came to me who had an adverse reaction to Sculptra®. Frequently the only way to get rid of these lumpy ridges is to excise (cut out) them from the face.
Nevertheless, the lay press, medical conferences and internet began to promote this substance for soft tissue augmentation in HIV negative patients. Although prospective studies for the use of this agent in individuals with normal immune functioning had not yet been completed in the United States, we did have reports of the European experience.
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.
Another product, Radiesse® (BioForm Medical, San Mateo, Calif.) is an injectable filler material composed of synthetic calcium hydroxylapatite microspheres (30 percent) suspended in an aqueous carrier gel (70 percent). At present, Radiesse® is indicated in the United States for correction of moderate to deep nasolabial folds and for correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Its off-label use in other facial aesthetic indications is widely reported in the literature. While a precise injection technique will supposedly minimize potential effects such as nodule formation and helped avoid persistent overcorrection, livid coloring, and asymmetry, the variation in injection techniques is immense. I personally have seen lumps in the cheeks, tear troughs and lips after Radiesse® use. Some of these lumps were over 2 years duration.
It is a strange time. Everyone wants to publish in the realm of minimally invasive aesthetics. Filler experts are everywhere and yet most fail to report adverse reactions to agents to which they are consultants. As a physician one must remember "everything that is obsolete was once new, which indicates that everything that is new is not necessarily better." Recently consultants have tried to blame bacterial colonization on the filler for adverse reactions. This is negated by what is found when filler problems are viewed under the microscope.
One would assume that the problems of these adverse reactions would be the topic of medical meetings and conventions. These meetings were at one time places where physicians eagerly shared their medical advancements and warned of adverse reactions. The hotels were moderate but ideas were intellectually exciting.
In 2009 medical meetings have become nothing more than trade shows where drug companies discuss and demonstrate their latest wares. The meetings are often held in grand resorts at distant foreign locales. Additionally, much of the medical literature itself has evolved into nothing more than promotional material of questionable accuracy also underwritten by Big Pharma. Presently even continuing medical education (CME) in the USA is no longer a science but a business where the manufacturers of these products promote the use of filler products and even teach off label use (using the product outside of what the FDA has approved it for) without regard for informing doctors of adverse reactions. The manufacturers underwrite the costs of these large conventions and CME courses to the tune of a billion dollars annually. In the world of facial Aesthetics especially this behavior is rampant.
When it becomes your time to fill; do some research beforehand. It could save you pain, expense and ultimately your face. Also find out what is in the needle before the needle goes into your skin.
Furthermore, it is time to keep Industry out of medical education, and prevent them from turning the medical literature into written advertisements. Most importantly you must keep industry away from your face!