Safety
The FDA has approved ArteFill® for the safe and effective correction of smile lines
Skin Test
An ArteFill Skin Test is a safety precaution to make sure that you are not allergic to the bovine collagen or anesthetic in ArteFill.
Precautions and Other Important Treatment Considerations
Some people should not receive ArteFill, including those who have a positive reaction to the ArteFill collagen skin test, have a history of severe allergies and anaphylaxis, have a known susceptibility to keloid (thick scar) formation and/or hypertrophy (excessive scarring), are allergic to lidocaine, are undergoing or planning to undergo desensitization injections to meat products, or are currently on corticosteroids or immunosuppressive therapy. Patients with any skin outbreaks (eg, cysts, pimples, rashes, hives, infection) near the injection site should postpone treatment until they clear. The most common adverse events associated with ArteFill injections are lumpiness, persistent swelling or redness, and increased sensitivity at the injection site. ArteFill is a permanent implant prescribed by a licensed physician. The safety and effectiveness of ArteFill beyond 1 year have not been established.
1ArteFill Instructions for Use. San Diego, Calif; Artes Medical, Inc.; 2006.
ArteFill Frequently Asked Questions
ArteFill Patient Label
Is ArteFill Right For Me?
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