FDA Approves Permanent Wrinkle Filler

November 2, 2006

The U.S. Food and Drug Administration has approved a new cosmetic filler known as Artefill® for the treatment of laugh lines, the deep wrinkles that appear around the nose and mouth.

Artefill is the first permanent injectable dermal filler, and its approval has been long anticipated. In 2004, the FDA issued an “approvable” letter to Artes Medical, the maker of Artefill, stating that the product could be approved if certain conditions were met.

On Monday, Artes Medical announced the FDA approval of Artefill, saying it planned to market the product directly to dermatologists and cosmetic surgeons. The filler differs from others like Restylane and Botox because it is non-resorbable, meaning it cannot be metabolized by the body.

“Based on ArteFill's proven results and high level of patient satisfaction observed in our clinical trials, ArteFill addresses the unmet patient demand for enduring wrinkle correction,” said Artes Medical president, Diane Goostree.

The filler is comprised of tiny plastic spheres, which are suspended in purified bovine collagen. Like other injectables, ArteFill is injected directly into the wrinkle – permanently plumping the depressed area.

Artes Medical said that the most common side effects observed in clinical trials included redness, uneven texture, swelling, and increased sensitivity.

Considering wrinkle treatment? Please contact us today to learn more about your options or to locate a board certified plastic surgeon near you.

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