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facial fillings, wrinkle surgery, botox
Ricardo Moraes/AP

Medical Panel Examines Risks of Facial Fillers

November 19, 2008 02:30 PM
by Isabel Cowles
An independent medical panel met to discuss the risks of facial filling injections, urging the FDA to require more stringent labeling and regulation.

Facial fillings not as pretty as they appear

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At a hearing on Tuesday, government health advisers urged the Food and Drug Administration to require more detailed product information about facial fillers used to treat wrinkles, in an attempt to reduce unsightly and potentially risky side effects.

A panel of doctors and health experts unanimously agreed that more safety studies are necessary to determine the overall risks of fillers: “This is almost a no-brainer. The current label is not adequate,” said panel member Dr. Michael Bigby, a dermatologist at Harvard Medical School.

Facial fillers have become increasingly popular in the last few years as a method of temporarily plumping skin and smoothing wrinkles. Filler injections differ from Botox, which is used to temporarily freeze muscles, giving the appearance of taut skin. Popular facial fillers include Juvederm, made by Allergan, Inc., and Restylane, produced by Medicis Aesthetics Holdings.
Cosmetic filler side effects have included skin bumps, disfigurement, facial paralysis and severe allergic reactions. Darker-skinned patients may also be experiencing skin blotches.

The American Society of Plastic Surgeons (ASPS) warns patients of some potential filler side effects, including “acne-like skin eruptions,” “asymmetry,” “bleeding, bruising and swelling,” and migration of filler material that could lead to temporary paralysis of muscle groups. The ASPS Web site also warns that “skin might die (skin necrosis).”

Related Topic: The FDA and Botox

In February 2008, the FDA issued sharp warnings against facial injections of Botox after several deaths were reported. According to the FDA release, “FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses.”

The fatalities associated with Botox occurred mostly in children who had been prescribed the drug to treat muscle spasms. Reporting on the FDA findings, CBS noted that “[i]n rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing.”

As early as 2003, the FDA told Botox manufacturer Allergan that its ads violated federal guidelines because they overstated the benefits and approved uses of Botox, while minimizing its risks.
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