(AIDSmeds.com) - BioForm Medical, Inc. announced on December 27 that the U.S. Food and Drug Administration (FDA) has approved Radiesse® for use in the correction of lipoatrophy of the face associated with HIV treatment. It is the second FDA-approved facial filler for this condition, following the approval of Dermik's Sculptra® in August 2004.
Radiesse contains man-made (synthetic) calcium hydroxylapatite, a substance found in bones and teeth. It was previously approved by the FDA for various uses in the United States, including orthopedic and reconstructive surgery and in dentistry. When it is injected into the skin, natural collagen forms around the calcium hydroxylapatite. This causes the skin to thicken, which can be useful in terms of masking the hollows in the face area associated with lipoatrophy.
Radiesse is considered to be a temporary filler, meaning that its cosmetic benefits decrease over time, usually within a few years of receiving the injections. According to BioForm Medical, it has been used in hundreds of thousands of procedures worldwide with an excellent safety record.
FDA approval was based on an August 24 recommendation from the agency's General and Plastic Surgery Devices Advisory panel. The panel's independent experts, reviewing a pre-market approval application for the product, agreed that Radiesse is safe and effective as an injectable device for the correction of facial lipoatrophy in people with HIV. Radiesse was also approved by the FDA as a filler material to cosmetically correct facial lines and wrinkles such as nasolabial folds.
"The injection technique is relatively simple," explains Joseph Eviatar, MD, of NYU Medical School in New York and a Radiesse researcher. "What you inject is pretty much what you get. In other words, if you inject a certain volume, that's what you'll see. You have to account for a little bit of swelling, but you can inject it where you'd like it and the product pretty much stays there. It's a soft and malleable product."
Stacey Silvers, MD, of Beth Israel Medical Center and another Radiesse researcher, agrees with Dr. Eviatar. "We've been very happy with this product in the study we've been participating in. The patients have also been very pleased with it so far. In European studies, it has been suggested that [Radiesse] is restorative for two to five years. We haven't seen this – we're seeing results lasting approximately a year to a year and a half – but it's one of the longest lasting fillers I've seen."
Now that the FDA has approved Radiesse, it is hoped that there will be greater access to the product through physicians and a better chance of insurance companies paying for the procedure.
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