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ArteFill® - P020012

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: ArteFill®
PMA Applicant: Artes Medical, Inc.
Address: 4660 La Jolla Village Drive, Suite 825 San Diego, CA 92122
Approval Date: October 27, 2006
Approval Letter: http://www.fda.gov/cdrh/pdf2/p020012a.pdf

What is it? ArteFill® is a filler that is injected into the nasolabial folds around the mouth to smooth these wrinkles. The device contains small polymethylmethacrylate beads, collagen and lidocaine.

How does it work? ArteFill® works by adding volume to nasolabial folds and restoring a smoother appearance.

When is it used? ArteFill® is injected by a doctor into the facial tissue around the mouth (i.e., nasolabial folds). The device adds volume to the skin and can give the appearance of a smoother surface.

What will it accomplish? ArteFill® will help smooth nasolabial folds around the mouth. In a clinical study most patients needed more than one injection to achieve optimal wrinkle smoothing. The average number of treatment sessions was 2.28.

Side effects of ArteFill® include:

• Lumpiness at injection area more than one month after injection
• Persistent swelling or redness
• Increased sensitivity
• Rash, itching more than 48 hours after injection

When should it not be used? ArteFill® should not be used in patients who have:

• A positive response to the ArteFill Skin Test
• Severe allergies with a history of anaphylaxis or presence of multiple severe allergies
• Allergies to bovine collagen or lidocaine
• Susceptibility to form keloid or hypertrophic scars

ArteFill® should not be used for:

• implantation into blood vessels, because it may obstruct blood flow
• lip augmentation or injection into the vermilion or the wet mucosa of the lip

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf2/p020012.html

Updated January 10, 2007

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