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WASHINGTON - They're drawn by the allure of ageless beauty.
Unfortunately, for some, the result can be blotchy skin, bumps on the face
and worse.
Hundreds of thousands of cosmetic surgery patients are turning to injections
of fillers to magically smooth the furrows of aging. On Tuesday, the Food
and Drug Administration is asking independent advisers to review the safety
of such products, increasingly popular for "minimally invasive" touchups to
improve appearance and give a little boost to deflated middle-age egos.
The agency also is seeking guidance on how to improve testing of fillers and
more clearly warn patients about potential risks.
Different from Botox, which is derived from a toxin that acts on facial
muscles, wrinkle fillers are like the biological equivalent of a bit of
spackle. Except they're injected into the face.
FDA officials are concerned that fillers are being used for purposes they
were never tested and approved for, such as plumping the lips, which are
extremely sensitive.
There are also questions about a lack of clinical evidence on how
darker-skinned patients fare with the beauty treatments. More black, Latino
and Asian patients are trying plastic surgery, and some information suggests
they may be susceptible to unsightly blotches and other complications from
fillers.
"The trouble is that once this material is in the hands of physicians,
there's really not much control over how it's used and where it's placed,"
said Dr. Scott Spear, a Washington plastic surgeon. "That creates the
potential for a certain amount of mischief.
"But the good news is that, by and large, these are very safe materials," he
added. "They have a very healthy risk profile."
FDA scientists will present the advisory panel with data on 823 patients who
suffered reactions after treatment with fillers between 2003 and this
September. The overwhelming majority were women, and the most common age
group was 50- to 60-year-olds. Plastic surgeons performed more than 1
million cosmetic surgery procedures with fillers last year alone.
Although no deaths were reported to the FDA, the complications were
troublesome enough that 638 of the patients required follow-up medical
treatment.
Most reactions involved minor swelling and redness, complications that could
be expected. But the FDA said it also received reports of "serious and
unexpected" problems, including facial, lip and eye paralysis,
disfigurement, vision complications and some severe allergic reactions.
A small number of patients -- 19 -- went to the emergency room with
life-threatening allergic reactions, such as difficulty breathing. Twelve
developed infections that required them to be hospitalized.
"The FDA has been rushing these products to market as if they were
lifesaving medical products," said consumer activist Diana Zuckerman,
president of the National Research Center for Women & Families. "They should
be requiring better studies since these products have only cosmetic benefits
but potentially lethal risks."
The American Society of Plastic Surgeons has concluded that wrinkle fillers
are safe, but believes better long-term monitoring of patients is needed.
"This is something that people don't do once, they keep coming back," said
Dr. Richard D'Amico, a New Jersey plastic surgeon who is immediate past
president of the group. "We all feel it's pretty important to monitor it as
we go long-term."
Some of the problems reported to the FDA may be due to unapproved or
"off-label" use of fillers. For example, the FDA does not recommend them for
plumping the lips, but some doctors see no problem with that.
Another challenge is the sheer variety of fillers. Most are eventually
absorbed into the body, but one type contains tiny, round, smooth
plastic particles that the body does not absorb. Some are made from
natural substances and others are not.
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