Wrinkle erasers under scrutiny

WASHINGTON, D.C.; November 18, 2008

Sculptra, Radiesse, and Juvederm are among the fillers that have made "facelifts by syringe" possible

Today, plastic surgeons pledged to help the government track the safety of them.

Women, and even some men, are drawn to skin fillers by the promise of youthful good looks at far less cost and trouble than a face lift. A "minimally invasive" touchup now and then can boost deflated middle-age egos. Unfortunately, for some patients, the result can be blotchy skin, bumps on the face and worse.

At a hearing Tuesday, the Food and Drug Administration asked independent advisers for recommendations on how to monitor the long-term safety of face fillers and for guidance on improving testing and warning patients about potential risks.

The American Society of Plastic Surgeons told the FDA advisers it is ready to take a leading role by encouraging the reporting of problems, improving training for doctors and their assistants, and advising consumers. "We feel it is time for medicine to step up and take the lead," said Dr. Richard D'Amico, a New Jersey plastic surgeon and immediate past president of the group.

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.

FDA has reports of 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, 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 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."

"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."

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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