WHAT IS ARTEFILL?
Artefill®. The Lasting Solution for Wrinkle Correction
Artefill is the first and only microsphere-enhanced collagen filler for the correction of nasolabial folds, or the lines from your nose to the corners of your mouth.
If you've used temporary dermal fillers in the past, then you know they are eventually absorbed by your body and require frequent repeat injections to maintain the results you've come to love.
Artefill is different. The unique microspheres contained within Artefill are not absorbed by the body, providing the support structure your skin needs for smooth, natural results. If you are looking for a long-lasting filler that you can have confidence in, then Artefill may be right for you.
HOW DOES ARTEFILL WORK?
Artefill is a dual-acting wrinkle filler. Once it’s injected into the deep portion of the skin under the wrinkle, the collagen in Artefill visibly corrects the wrinkle. Over time the collagen is absorbed by the body but the microspheres remain intact providing the support your skin needs for long-lasting, natural feeling wrinkle correction.
This safe, in-office procedure takes a just a few minutes to administer. You will receive an anesthetic to lessen the pain from the procedure and with proper placement you won’t feel a thing and can return to your normal daily activities. The results are immediate and will improve over time.
If you love the wrinkle correction you get from temporary fillers but are tired of retuning for repeat treatments, then Artefill may be the ideal solution for you.
Artefill is the only soft tissue filler product on the market designed to last. Thousands of patients in the U.S. have been successfully treated with Artefill and those numbers continue to increase. Artefill is also one of the only products to report a patient satisfaction rating over 90% during its pivotal clinical trial. Listen to what some actual patients had to say about their experience with Artefill at http://www.artefill.com/content/c/patientexperiences/overview.asp.
Q: What is Artefill?
A: Artefill is the long lasting solution for wrinkle correction. Artefill consists of a combination of microsphere enhanced collagen and lidocaine for comfort.
Q: How does Artefill work?
A: The collagen gel acts as a carrier for the microspheres in Artefill. Gradually, your body absorbs the collagen while the microspheres remain to provide a long lasting support structure below the wrinkle to sustain wrinkle correction.
Q: Is Artefill safe?
A: Yes. Artefill has proven to be a safe and effective dermal filler for the correction of wrinkles and was approved by the U.S. FDA in October 2006. In clinical testing, Artefill was as safe as the control temporary filler.
Since the launch of Artefill in 2007, thousands of patients have been safely treated with Artefill and there have been no product recalls and no reported medical device events.
Q: How does Artefill differ from temporary 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 lasts for only 3-9 months.
The microsphere enhanced collagen in Artefill remains intact at the treatment site and provides structural support to keep your wrinkle from returning.
Q: Can anyone have Artefill treatments?
A: No. Some people are not good candidates for Artefill.
Artefill is contraindicated in those who:
- have a positive reaction to the Artefill skin test
- have a history of severe allergies and hypersensitivity (anaphylaxis)
- are allergic to the anesthetic (lidocaine) in Artefill
- have a history of allergies to any collagen products
- are prone to thick scarring (hypertrophic) formation and/or excessive scarring (keloid)
- are undergoing or planning to undergo desensitization injections to meat products
Q: Are there any other treatment concerns with Artefill?
A: Yes. If you have any skin outbreaks (e.g. cysts, pimples, rashes, hives, infection) near the injection site, you should postpone treatment until they clear. If you are taking aspirin (NSAIDs) or anti-inflammatory drugs or have any medical condition that affects your blood, you may experience increased bruising or bleeding at the injection sites.
In addition, you should inform us if:
- you have had any treatments for smile lines in the last 6 months
- you are receiving UV light therapy
- you are currently on immunosuppressive therapy (medication commonly prescribed for those who have undergone an organ transplant, or are suffering from rheumatoid arthritis, psoriasis, inflammatory bowel disease, or cancer)
Q: Are there any further precautions with Artefill?
A: Yes, you should know:
- Artefill contains microspheres that help provide the support for wrinkle correction- the microspheres can only be surgically removed
- The safety of Artefill in pregnant or breastfeeding women, and individuals under 18, has not been established
As with any injectable filler, there is always a risk of infection.
Q: Are there any possible side effects with Artefill?
A: As with any injectable wrinkle filler, you can expect mild swelling and reddening at the treatment site. These side effects are usually gone within 24 hours. Occasionally, there is mild bruising that typically disappears in three to seven days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at some or all injection sites. Two other rare potential side effects of all dermal fillers may be lumps and granulomas, both of which can be treated by your physician.
Q: When will I see results with Artefill and how long will the results last?
A: You will see results immediately. In the U.S. clinical study, full wrinkle correction was maintained for up to one year.
Q: Is one treatment enough to get the look I want?
A: Most people get the results they want with one or two treatments, depending on the depth of their wrinkles and folds. When you have your follow-up appointment in four to six weeks, you can decide if you would like to further enhance your results.
Q: How will my face feel following treatment?
A: With proper placement, Artefill may not be felt after treatment. You will see the results
immediately and be able to return to your normal daily activities.
Q: How will I look as my skin ages after treatment with Artefill?
A: Studies have shown that patients injected with microsphere-enhanced collagen, still reflect a natural appearance in both their overall facial appearance as well as in the area treated 5 years from their initial treatment. These patients were surveyed and had a 90% satisfaction rating related to their wrinkle correction and experience with Artefill.
Q: Why is a skin test required before treatment with Artefill?
A. The skin test is a safety precaution to ensure that you are not allergic to the collagen or anesthetic in Artefill.
Q: What process did Artefill go through before it was FDA approved?
A: Several clinical studies were conducted in the United States to demonstrate the safety and effectiveness of the 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. Artefill was approved by the FDA in October 2006.
Q: What is the long term safety of microsphere-enhanced collagen treatments?
A: A follow-up study of patients from the controlled clinical study 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 the treatment safely maintains significant correction of smile lines for at least five (5) years post-treatment.
Q: Are there any current studies being conducted on Artefill?
A: Yes. A post-approval marketing study was initiated in October 2007 to evaluate the long term safety of Artefill. The study will follow 1,000 patients treated with Artefill for a period of five years.
Q: How many patients have been treated with the product?
A: To date, thousands of patients in the U.S. have been treated successfully with Artefill.
Q: I have heard some patients develop persistent lumps in their skin after treatment with Artefill, is this true?
A: Persistent lumps are a rare potential side effect of all dermal fillers, including Artefill, and can be treated effectively.
Q: If I have had a negative collagen skin test previously, do I need to have
another skin test with Artefill?
A: Yes, an Artefill skin test is required prior to treatment to make sure that you are not allergic to the collagen in Artefill.