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Safety and Efficacy Data
SAFETY INFORMATION
Artefill® has proven to be a safe and effective dermal filler for the correction of nasolabial folds and was approved by the U.S. FDA in October 2006.
In the U.S. pivotal prospective and open-label clinical trials, Artefill was as safe as the control temporary filler.
Since the launch of Artefill in 2007, over 20,000 patients have been safely treated with Artefill and there have been no product recalls and no reported medical device events.
Suneva Medical discourages physicians from injecting Artefill in the same anatomical site(s) that have been previously treated with non-FDA approved PMMA-based dermal fillers. The safety profile of non-FDA approved PMMA-based dermal fillers in combination with Artefill has not been established.
Important Safety Information
Licensed physicians are required to perform an Artefill Skin Test as a safety precaution to make sure that patients are not allergic to the collagen or anesthetic in Artefill. 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 (e.g. 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. The safety and effectiveness of Artefill beyond one year have not been established.
