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Cosmetic concerns

For years people have been paying big bucks for cosmetic bliss, using plastic surgery or face-filling techniques to get rid of wrinkles and lines. But while the practice is popular it hasn't always been properly regulated.

For years people have been paying big bucks for cosmetic bliss, using plastic surgery or face-filling techniques to get rid of wrinkles and lines.

But while the practice is popular it hasn't always been properly regulated.

That's why area doctors like Susan Mathison, a Fargo doctor specializing in plastic surgery, say strong doctor-patient consultation and continued training on plastic surgery procedures are vital in ensuring proper medical treatment.

Her words are similar to a recommendation by government health advisors who believe cosmetic surgery patients interested in face fillers should be informed of their possible risks. Injected into the face, they smooth away wrinkles.

The gel-like fillers have become immensely popular with baby boomers.

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Mathison, who practices at Catalyst Medical Center, says 95 percent of her patients interested in face fillers are women. "A lot are working moms who want to feel good," she says.

A panel of independent advisers is urging the Food and Drug Administration to revise information for consumers and doctors - called the product label - to include the risk of long lasting reactions such as bumps under the skin, blotches and scars.

"This is almost a no-brainer," says panel member Dr. Michael Bigby, a Harvard Medical School dermatologist. "The current label is not adequate."

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. They include such products as Juvederm, made by Allergan Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested nor approved for, not just erasing wrinkles. These include plumping the lips, cheeks and breasts.

"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," says 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," Spear adds. "They have a very healthy risk profile."

Mathison says she also believes face fillers are safe for patients, adding that some European doctors used face fillers before they were used in the United States.

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Most patients get a couple of touchups a year, at costs that can easily exceed $1,000 each.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But an FDA hearing in November raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. It was a first step as the FDA considers whether to regulate fillers more closely.

Mathison says only doctors at her private practice perform surgical procedures.

Plastic surgeons pledged to help find a new consensus on how to track safety, improve training and provide clearer information to consumers.

"We feel it's time for medicine to step up and take the lead," says Dr. Richard D'Amico of New Jersey, representing the American Society of Plastic Surgeons.

Collagen, one of the first face fillers used by cosmetic surgeons, lasts only 2 to 3 months, Mathison says. It's also made from a bovine product that affected patients with allergies, she says.

In comparison, Restylane can last from 6 to 9 months as a face filler, Mathison says.

Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

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The FDA presented data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. Nearly all were women, and the most common age group was 50- to 60-year-olds.

Although no deaths were reported, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

"Patients don't want to get rid of wrinkles and end up with large bumps on the face instead," says consumer activist Diana Zuckerman, president of the National Research Center for Women & Families.

"Most cases reported to the FDA involved complications that could be foreseen, such as swelling and redness. But there were also "serious and unexpected" reactions, including facial, lip and eye paralysis, disfigurement, vision problems and some severe allergic reactions.

Nineteen patients went to the emergency room with life-threatening allergic reactions. Twelve developed infections that required hospitalization.

Some problems reported to the FDA may be due to unapproved or "off-label" use of fillers.

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. That means they may react differently in the body.

"Some of these products don't have a lot of adverse events and some do," says Zuckerman. "How are we going to help patients make decisions without more information?"

Copyright © 2008 The Forum. All rights reserved. AP contributed to this report.

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