Antiwrinkle Shots Spark Debate

By RHONDA L. RUNDLE

October 31, 2006

Artes Medical Inc. said it received U.S. Food and Drug Administration
approval to market the cosmetic injectable ArteFill for treating
wrinkles running from the nose to the corners of the mouth. The product
has stirred controversy because it stays in the body permanently, unlike
other antiwrinkle shots that wear off after four to six months.

ArteFill is administered in a physician's office and typically requires
15 to 30 minutes. The experience for patients is similar to that of
injectable temporary dermal fillers, "but the results are expected to
last for years," according to the closely held San Diego company.
ArteFill is expected to appeal to patients who are tired of repeated
injections. But some doctors worry that problems could be permanent,
too, and question how a treated face will look as it continues to age
over time.

Despite such concerns, "there are plenty of people suffering from
'injection fatigue' who are interested in a longer-lasting filler," said
Mark Rubin, a Beverly Hills dermatologist who said he is preparing to
offer ArteFill to his patients. While the FDA approved ArteFill for the
correction of smile lines, he expects physicians over the course of a
few months to start using it in the so-called marionette lines, from the
corner of the lip down to the chin. "It's not a product for the lips,"
he cautioned.

ArteFill is made from microscopic synthetic beads suspended in collagen
extracted from cow hides. The beads act as a scaffold around which a
patient's natural tissue grows. The collagen is absorbed by the body in
a few months, but the beads remain indefinitely. Some researchers in
Europe and Canada have reported foreign-body reactions to the product,
especially in the lips. In the FDA tests, however, "there was no
significant difference in the safety profile of ArteFill and a collagen
product already on the market, Artes said.

Dr. Rubin said that there will be a percentage of physicians and
patients who won't want to use ArteFill because of its connection to a
predecessor product that caused complications. "[ArteFill] has been
maligned because of the original product," he said. "There's no question
they had a significant number of adverse events. But they changed the
size of the bead and the carrier material and the problems dropped
precipitiously." Foreign body reactions are treatable and have been seen
with all the dermal fillers, he added.

At a meeting last week in Palm Desert, Calif., physicians debated the
risks and benefits of longer lasting fillers, which are starting to come
to market. Arnold Klein, a Beverly Hills dermatologist and professor of
dermatology and medicine at the University of California at Los Angeles
gave a speech warning of potential dangers. ArteFill, he said, is an
"injectable plexiglass. Do you want that in your face?" he asked
rhetorically.

Many doctors said they will wait and see how ArteFill performs before
offering it to patients. It "has a somewhat spotty history in other
countries and can lead to long term lumps under the skin that don't heal
unless they are injected multiple times with steroids or are excised,"
said Joel Schlessinger, an Omaha, Neb., dermatologist who said he is an
Artes consultant. Kenneth Beer, a dermatologic surgeon in Palm Beach,
Fla, said: "I'm a little bit scared of it. After it's out for a while, I
might revisit it."

An Artes spokesman said company officials couldn't discuss ArteFill,
citing the company's May filing with the Securities and Exchange
Commission for an initial public offering.