ArteFill
Q: What is ArteFill?
A: 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.
Q: How is ArteFill different from temporary dermal fillers?
A: 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.
Q: Why is ArteFill different from temporary dermal fillers?
A: 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.
Q: Why was ArteFill developed?
A: Many physicians and patients desire a longer lasting wrinkle filler due to the time and cost associated with temporary fillers. ArteFill represents a novel solution for those patients who do not want to return for repeat treatments with temporary dermal fillers.
Q: What is in ArteFill?
A: 20% of the material in ArteFill consists of tiny round, smooth microspheres that are about half the width of a human hair. The remaining 80% of the material is purified collagen that serves as a carrier gel for the microspheres. This gel is absorbed by the body while the microspheres provide the support your skin needs for long-lasting wrinkle correction. ArteFill also contains an anesthetic to make the treatment more comfortable.
Q: What exactly are the microspheres in ArteFill?
A: These tiny microspheres are made of polymethylmethacrylate (PMMA), one of the most commonly used artificial implant materials in medicine. PMMA is widely used for intraocular lenses and as a bone substitute due to its biocompatibility and proven safety in over 60 years of clinical use. With ArteFill, the microspheres remain intact at the injection site and provide a permanent structure to support the wrinkle and help prevent further wrinkling.
Q: What happens after the microspheres are injected?
A: ArteFill is injected deep in the skin underneath the wrinkle and just above the skin’s fat layer. Several scientific journals have described the expected and appropriate response to the PMMA microspheres. These findings concluded that the bovine collagen surrounds the microspheres and holds them in place.
Q: How will my face feel following treatment?
A: With proper placement, the material connot be felt after treatment. You will see the results immediately and be able to return to your normal daily activities shortly after your treatment.
Q: How will I look as my skin ages after treatment with ArteFill?
A: Patients from the original clinical trial that are now more than 5 years out from their initial treatment reflect a natural appearance in both their overall facial appearance as well as in the area treated with ArteFill. These patients were surveyed and had a very high satisfaction rate related to their wrinkle correction and experience with ArteFill.
Q: Why is a skin test required before treatment with ArteFill?
A: The ArteFill skin test is a step to ensure that you are not allergic to the bovine collagen gel.
Q: What process did ArteFill go through before it was FDA approved?
A: 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.
Q: How does ArteFill differ from Artecoil®?
A: ArteFill represents the next generation of this PMMA-based dermal filler technology. Its predecessor, Artcoil, 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.
Q: Does the FDA review the safety of wrinkle fillers after they are on the market?
A: 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.
Q: What is the long-term safety of ArteFill?
A: 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.
Q: Are there any current studies being conducted on ArteFill?
A: 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.
