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FDA panel urges OK of new wrinkle
treatment
Friday, February
28, 2003 Posted: 3:14 PM EST (2014 GMT)
GAITHERSBURG, Maryland (Reuters) -- A U.S. advisory panel
Friday urged regulators to approve the use of an injection
of collagen and tiny plastic beads as a long-term fix for
wrinkles.
Artecoll,
made by privately held Artes Medical, could provide competition
to the Botox and collagen shots that are popular with Americans
craving a younger look.
Results from those injections last up to about six months.
Artecoll, by contrast, is a permanent implant for ironing
out wrinkles long-term, its maker said.
A study presented to a Food and Drug Administration advisory
panel compared results from collagen and Artecoll six months
after the injections.
"The data is pretty convincing it's effective," said Dr.
Michael Miller, a panel member and plastic surgeon from the
University of Texas M.D. Anderson Cancer Center.
The panel voted 4-1 to recommend Artecoll's approval, giving
the product a major boost toward the market, since the FDA
usually follows its panels' advice.
Panel members said it was important to make sure physicians
were skilled in injecting the permanent material. They also
said patients should be informed of potential risks, which
can include lumps on the face.
The panel also said it favored post-marketing studies of
patients at least five years after patients received injections,
and said the product should not be approved for lip augmentation.
Artecoll contains tiny spheres of polymethylmethacrylate,
or PMMA for short, suspended in bovine collagen. PMMA is a
polymer which has been used for more than 50 years in medical
devices ranging from contact lenses to bone implants.
The PMMA spheres, about the thickness of a human hair, settle
in wrinkles as the bovine collagen gradually absorbs into
the body, the maker said. Then, the spheres stimulate the
body's own collagen to encapsulate them.
A study found Artecoll patients had less severe lines between
the nose and lips than collagen patients six months after
treatment, as judged by researchers who reviewed patient photos.
The study did not show a statistically meaningful difference
between the two treatments in other areas of the face at the
same time point, FDA reviewers said.
For some patients in Europe, where the product has been available
for years, Artecoll's effects have lasted up to 10 years,
company officials said.
FDA reviewer Binita Ashar said 16.3 percent of patients treated
with Artecoll experienced an "adverse event," such as lumping
or redness. Thirteen percent of collagen patients had adverse
events. More Artecoll patients had lumpiness that persisted
beyond six months, Ashar said.
Artes Medical said lumps were treatable with cortisone shots.
"I have never heard of any long-lasting disfigurement after
Artecoll injections," said Dr. Gottfried Lemperle, Artecoll's
inventor and the chief scientific officer for Artes Medical.
But Diana Zuckerman, president of the National Center for
Policy Research for Women and Families, said the FDA should
require longer studies before approving Artecoll.
"If this product is approved, tens of thousands of women
-- probably even more -- will have this product permanently
injected in their faces. And yet, we really have no idea what
will happen to them after two or three or four or 10 years,"
she told the panel.
Company officials said they expect a final decision from
the FDA in the coming months. If approved, Artecoll would
be sold in the United States under the brand name Artefill.
Artes
Medical is based in San Diego. Irvine, California-based Allergan
Inc. makes Botox , which smooths wrinkles by paralyzing the
muscles that cause facial lines. Inamed Corp. of Santa Barbara,
California, sells collagen under the brand names Zyderm and
Zyplast.
Copyright 2003 Reuters. All rights
reserved. This material may not be published, broadcast, rewritten,
or redistributed.
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