Facial Wrinkles are a result of the natural aging process. Over time, the skin loses its ability to repair itself as the underlying elastin and collagen break down. Heredity, UV exposure, and repetitive facial movement can all contribute to the development of facial wrinkles and folds.
ArteFill is the first and only FDA-approved non-resorbable wrinkle filler for the correction of smiles lines.
- Immediate, visible results with no downtime
- A simple, in-office procedure
- Excellent safety profile
- Results improve over the course of several months and stand the test of time
What is ArteFill?
ArteFill is the first and only FDA-approved non-resorbable dermal filler for the correction of facial wrinkles known as smile lines that provides enduring wrinkle correction.
How is ArteFill different from temporary dermal fillers?
Temporary dermal fillers are made of different kinds of natural or synthetic materials that are completely absorbed by the body over time and as a result wrinkle correction usually only lasts a few months.
Why is ArteFill different from temporary dermal fillers?
ArteFill is a wrinkle filler that stands the test of time. The unique microspheres in ArteFill are not absorbed by the body and provide a permanent support structure your skin needs for long-lasting wrinkle correction.
What process did ArteFill go through before it was FDA approved?
Artes Medical conducted clinical studies in the United States to demonstrate the safety and effectiveness of our microsphere dermal filler technology. The data from our clinical trials were subject to a full and open review in a public hearing by an FDA review panel. During the review, we worked with the FDA to further enhance our manufacturing process and testing to ensure that ArteFill meets the highest quality standards. ArteFill was approved by the FDA in October 2006 after eight years of clinical study and review.
How does ArteFill differ from Artecoll®?
ArteFill represents the next generation of this PMMA-based dermal filler technology. Its predecessor, Artecoll, has been available outside of the United States since 1994. However, only the enhanced Artefill formulation has been FDA approved as it meets or exceeds the rigorous safety, quality, and manufacturing standards required by the FDA.
Does the FDA review the safety of wrinkle fillers after they are on the market?
Yes, the FDA reviews the post-marketing experience of all dermal fillers. All adverse events not included in the product labeling must be reported to the FDA. Since the launch of ArteFill in February 2007, there have been no significant differences in the product’s safety profile as compared to the events reported during the clinical study.
What is the long-term safety of ArteFill?
Artes Medical recently completed a follow-up study of patients from the controlled clinical study that began in 1999. These patients were followed over a 5-year period after treatment. Independent expert observers rated photographs of patient wrinkles at five years compared to before treatment and six months after treatment. The physician investigators of this follow-up study concluded that ArteFill safely maintains significant correction of smile lines for at least five years post-treatment. Results of this study have been submitted to the FDA as well as a peer-reviewed journal, which is expected to publish the results soon. No other dermal filler company has submitted a five-year follow-up study of its safety and effectiveness to the FDA.
Are there any current studies being conducted on ArteFill?
Yes. Treatment has started in a new 1000-patient post-marketing study that will follow patients treated with ArteFill for a period of five years. Study participants will receive ArteFill injections into their smile lines at up to 25 leading dermatology and plastic surgery centers throughout the United States and Canada.