Aesthetic Trends & Technologies Dermatology Winter 2009
ARTEFILL IS BACK!
Artefill was approved in late 2006 for the correction of naso-labial folds. In 2008, despite gaining popularity and having an excellent safety and efficacy profile, the fragile economy forced Artes, the previous maker of Artefill, out of business. Now, thanks to Suneva Medical, Artefill has a new home.
By Lorrie Klein, M.D.
Artefill is the longest lasting dermal filler available in the U.S. that has been clinically proven to last up to 5 years. The FDA approved labeling states that results last up to 12 months. Artefill contains tiny PMMA (poly-methyl-methacrylate) microspheres in a purified bovine collagen gel with an anesthetic for comfort during injection. The bovine collagen acts as a carrier for the PMMA and dissolves over several months, leaving the purified microspheres in the skin.
These microspheres provide structure, like scaffolding, around which skin will then build its own natural collagen. PMMA is one of the most widely used synthetic implant materials in medicine.
Artefill is a more purified product than its predecessor product Artecoll which has been safely used in Canada for many years, but was not approved in the U.S. Other earlier versions of PMMA-based fillers from Europe and South America have a higher rate of safety issues and have experienced problems which have been attributed to PMMA impurities as well as microsphere size, uniformity, and surface characteristics.
The FDA Review Process
The FDA’s strict review process and standards for microsphere size required more uniformity in the microsphere technology before approval in the United States. In studies, safety data showed Artefill had no significant side effects and minor side effects equal to that of placebo. Studies on Artefill show safety continued efficacy in patients five years after their injections. READ ON…Download Article - HERE!
About the Author
Lorrie Klein, M.D. is founder and Medical Director of Euro Day Spa, Inc., a Diplomate of the American Board of Dermatology, and a Fellow of the American Academy of Dermatology. Dr. Klein is a consultant for Allergan, Bioform, and Suneva. She practices dermatology in Laguna Niguel, CA. Visit Dr. Klein on the worldwide web at www.OCdermatology.com.
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