Second Facial Filler for HIV Lipoatrophy Receives Approval Recommendation
by Tim Horn
August 29, 2006 (AIDSmeds)—BioForm Medical, Inc. announced on August 24th that an
advisory committee to the U.S. Food and Drug Administration (FDA) has
recommended the approval of Radiesse™ for use in the correction of lipoatrophy
(loss of fat) of the face associated with HIV treatment. If approved,
it will be the second FDA-screened 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 is currently 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.
The General and Plastic Surgery Devices Advisory
Panel recommended approval of Radiesse following the review of data
from a pre-market approval application (PMA) for the product to be used
as an injectable device intended for use in the correction of facial
lipoatrophy in people with HIV. Radiesse was also recommended for
approval to be used as a filler material to correct facial lines and
wrinkles such as nasolabial folds.
"The injection
technique is relatively simple," explained 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, agreed 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."
While the FDA is not required to agree with the
advisory committee's recommendation, it usually does. With FDA approval
of the product for HIV-positive people with lipoatrophy, there will be
greater access to the product through physicians and, with hope, a
better chance of insurance companies paying for the procedure.
