ArteFill, produced by Artes Medical, is an improved version of Artecoll, which has been used in Europe and Canada on more than 400,000 patients during the past 10 years. ArteFill was FDA approved in October 2006 for the treatment of nasolabial folds (smile lines) and has also been used off-label for lip augmentation, acne scars, and other wrinkles. ArteFill is a gel filler consisting of millions of synthetic microspheres (polymethylmethacrylate or PMMA) suspended in purified bovine (cow) collagen. ArteFill also contains the local anesthetic lidocaine to reduce discomfort during injection.ArteFill is the first and only FDA-approved injectable wrinkle filler designed for the correction of smile lines that doesn't get absorbed into the body. So you can look younger, longer with a filler that truly lasts. All it requires is a simple, in-office procedure for immediate wrinkle correction that stands the test of time. And thousands of women and men who have had ArteFill are still loving their results.
If you've used temporary dermal fillers such as Restylane, Juvederm TM, Radiesse or Sculptra in the past, then you know that 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 microsphere technology within ArteFill is not absorbed by the body and therefore provides the permanent support your skin needs for long-lasting results.Why ArteFill?
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 fibers break down and lose elasticity. 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 smile lines.ArteFill is injected directly beneath the wrinkle to add a permanent support structure and smoothen the area. The synthetic PMMA microspheres in ArteFill are "non-resorbable," which means they are not absorbed into the body or metabolized, allowing ArteFill to last significantly longer than other injectable fillers. The microspheres stimulate the body to generate its own natural collagen to encapsulate each individual microsphere, resulting in 80% of the patient's collagen and 20% microspheres (by volume) to permanently fill in the wrinkle. As the injected bovine collagen is slowly absorbed during a few weeks, the newly generated collagen replaces it. This slow breakdown and natural replenishment process provides ArteFill with its unique and enduring results. Recently Artes Medical submitted five-year safety and efficacy data from its U.S. clinical trial patients to the FDA in order to expand the product's labeling. The data show a statistically significant improvement of wrinkle correction between six months and five years after the initial injection, which is attributed to the ongoing collagen remodeling process around the PMMA microspheres.
Some of the benefits of ArteFill Treatment are as follows:
FDA approved
Immediate, visible results with no down time
A simple, in-office procedure
Excellent safety profile
Results improve over the course of several months and stand the test of time
Usually requires only 1 or 2 treatments
Personalized ArteFill Progressive Enhancement TM (gradual wrinkle correction) helps ensure the look you desire
ArteFill is a dual-acting injectable wrinkle filler. The secret is in its patented formula, which contains 20% ArteFill Precision-Filtered Microspheres™ (made of PMMA, the same material used for dozens of medical implants over the last 50 years) and 80% ArteFill Purified Bovine Collagen™ gel with lidocaine, an anesthetic. First, ArteFill visibly corrects the wrinkle. Then the microspheres provide the permanent support your skin needs to correct the wrinkle and prevent further wrinkling. Where the results of temporary fillers end, the enduring benefits of ArteFill continue.
Men and women of any age may receive ArteFill treatment. Ideal candidates have already tried temporary injections, are injection- and credit card-fatigued, and are sure they want a permanent result. ArteFill is not given to people with allergies to bovine collagen or with chronic skin infections. And it is not recommended for areas of thinner skin (such as crow's feet around the eyes).
Before treatment, your doctor will administer a simple allergy skin test for sensitivity to bovine collagen. ArteFill treatment usually requires only 15-20 minutes, but two treatment sessions may be necessary to achieve full wrinkle correction. The treatments are typically performed three to six weeks apart. Before receiving ArteFill, you may first try a temporary filler to confirm your desired result. Be sure to seek advice and treatment only from board-certified plastic surgeons or dermatologists with sufficient experience in the ArteFill injection technique, as well as other injectable fillers.
Side effects from ArteFill are rare but may include redness, swelling, lumpiness, pain, or sensitivity at the injection site. Some patients may feel a slight firmness after injection, which usually resolves over time. ArteFill® is the First FDA-Approved Non-Resorbable Aesthetic Injectable Implant for the Correction of Nasolabial Folds ArteFill is a unique combination of homogeneous precision-filtered microspheres suspended in a solution of purified collagen gel and 0.3% lidocaine to alleviate discomfort during injection. ArteFill is manufactured in our dedicated 35,000 sq ft current good manufacturing practices (cGMP) compliant manufacturing facility and corporate headquarters in San Diego. In October 2006, ArteFill received final approval from the FDA, making it the first and only non-resorbable aesthetic injectable implant to gain FDA approval. ArteFill Is Different From Dermal Fillers ArteFill is designed with dual action to correct facial wrinkles, known as nasolabial folds. ArteFill does this as a result of its composition, which is a combination of precision-filtered microspheres (20% of total volume) made from polymethylmethacrylate (PMMA) and purified bovine collagen (80% of total volume). All microspheres have a defined size of 30 to 50 microns in diameter and have a smooth, round surface. Aesthetic results are visible immediately after injection. PMMA is not taken up by scavenger cells (macrophages) and cannot be degraded by enzymes. Thus, the microspheres will remain intact beneath the creases, providing a permanent support structure to support the wrinkle and to prevent further wrinkling. As with all products using bovine collagen, a skin sensitivity test must be performed prior to use. In contrast, FDA-approved temporary "starter" filler treatments using biological fillers to increase the thickness of the skin, such as autologous fat, bovine collagen (Zyderm®, Zyplast®) human collagen (CosmoDerm®, CosmoPlast®), and hyaluronic acid (Restylane®, Hylaform®, Juvedérm®), provide only temporary effects because they are naturally absorbed by the body within a few months following implantation. Using temporary fillers makes it difficult to keep the improved look consistent over time because regular repeat injections are necessary, and the time, cost, and pain associated with such re-treatments are significant.
ArteFill Safety Features
- Precision-filtered, suspended, PMMA microspheres optimized over 3 generations Purified bovine collagen gel Collagen source is a closed herd in the U.S. (FDA-compliant) Proprietary, non-porous syringes contain 0.8 cc and 0.4 cc ArteFill Optimized injection flow characteristics Pharmaceutical-grade product manufactured in a fully dedicated cGMP facility in San Diego, California
After injection, some common, temporary, injection-related reactions might occur: tenderness, redness, itching, bruising, bumps, pain or swelling. If any of these occur, they typically resolve within a few days. We recommend planning your treatments at least one week before any special events. Rare potential side effects of all dermal fillers may be lumps, abscesses and granulomas, which are usually treatable. Aftercare: No special care is needed after treatment, however we advise you not to massage the area on the day of your treatment, as this may displace the gel. Exaggerated facial expression during the first 24 hours may also displace the gel, so avoid prolonged laughing, playing musical instruments with your mouth and sleeping on your face. Apply cold packs for 10-15 minutes every 1-2 hours until bedtime on the day of your treatment to reduce swelling & bruising.
Artefill is not recommended for certain people. For complete safety information visit Artefill.com As you age, your collagen breaks down and the elastin in your skin becomes worn out. Those looking to avoid the effects that this aging process has on the skin currently have a few options. You can try various wrinkle creams until you find one that works or you can get injections. Artefill is an FDA approved wrinkle filler that is injected into your face by a physician or lab/ spa attendant trained and certified to perform this simple procedure. Artefill is a wrinkle filling product that was designed to eliminate smile lines and other wrinkles on a person’s face. These wrinkles could be due to age, heredity, or other enivronmental factors, and Artefill claims to give very noticeable wrinkle-erasing results. There are many before and after pictures on the website that do show a very dramatic difference in the appearance of wrinkles after 6 months to a year of treatments with Artefill. Artefill is billed as a “dual-acting” wrinkle fighter because it not only fixes the wrinkles in appearance, it also helps support your skin over time. This product is different from your average temporary dermal fillers because Artefill doesn't get absorbed into the body like most fillers. This, the manufacturers claim gives it a much longer lifespan that will require fewer applications.
Artefill has been tested and studied extensively and it is FDA approved. This is a fairly safe and side-effect free way to eliminate wrinkle lines for a long-term time span. Artefill might be worth taking a look at if you are considering another type of injection such as Botox or a temporary dermal filler of some kind. If you aren't fond of needles or are on a budget, you may not be interested in Artefill but it does seem to offer results for those willing to go “under the needle.”
Schedule for an Artefill appointment by calling or emailing us and our Artefill specialist will discuss with you the treatment process. This free consultation will help you learn more about how Artefill works and also the cost and the necessary preparations you will need for your Artefill treatment. You would love your new smoother and younger look!
Laser, Beauty and Wellness Center at Orange County Medical Spa is only a few minutes away from cities such as Anaheim, Buena Park, Cerritos, Garden Grove, Irvine and Tustin. Our facility is the ideal place to go for your non-surgical medical cosmetic procedure and aesthetic spa treatment if you live in or near Orange County.
Frequently Asked Questions (FAQs) about ArteFill
- What is ArteFill?
ArteFill is the first and only FDA-approved non-resorbable injectable filler for the correction of wrinkles known as smile lines. It contains 20% tiny round and smooth particles (PMMA microspheres) and 80% purified bovine collagen gel with 0.3% lidocaine, an anesthetic.
How does ArteFill work?
ArteFill is a dual-acting injectable wrinkle filler. First, ArteFill visibly corrects the wrinkle. Then the microspheres provide the permanent support your skin needs for long-lasting wrinkle correction.
How is ArteFill injected?
ArteFill is injected underneath the wrinkle, just above the skin’s fat layer. ArteFill provides the soft, supportive foundation that your skin needs for long-lasting wrinkle correction.
How is ArteFill different from temporary dermal fillers?
All temporary fillers are eventually absorbed by the body. That’s why they require frequent repeat injections. ArteFill is different. The unique microspheres in ArteFill are not absorbed by the body. These microspheres provide the permanent support your skin needs for long-lasting wrinkle correction. Now, with ArteFill, you can get the lasting wrinkle correction you want in just one or two treatments. Where the results of temporary fillers end, the long-lasting benefits of ArteFill continue.
What clinical studies were conducted on ArteFill?
Artes Medical conducted two clinical studies in the United States to demonstrate the safety and effectiveness of ArteFill. One study was primarily to determine ArteFill’s safety and the second study was to determine both the safety and effectiveness of ArteFill.
- Clinical Study #1. In this safety study, both the doctors and the patients knew that ArteFill was being injected. This multi-center study reviewed the safety of ArteFill injections for the correction of facial wrinkles. 157 patients were enrolled and monitored at 3, 6, and 12 months after treatment. 126 out of the 157 patients (80%) completed the 1-year study. The safety data from this study was combined with the safety data from the controlled study to define the safety record for ArteFill.
- Clinical Study #2. A controlled study conducted at 8 research clinics compared the safety and efficacy of ArteFill and a commercially available collagen implant for the treatment of facial wrinkles in a total of 251 patients. The patients were randomly divided into two groups with 128 patients receiving ArteFill and 123 receiving collagen injections. After 6 months, the effect of ArteFill was compared to the collagen patients who served as the control group. Photographs were taken of all of the treated wrinkles at each office visit and evaluated by a separate group of doctors who were not involved in treating the patients. These doctors evaluated the coded photographs using a standardized rating scale to grade the effectiveness of both the ArteFill and control collagen results. Safety was evaluated by comparing the number and severity of side effects during and for 12 months after treatment.
- What were the results of the clinical studies?
The safety record for ArteFill and the control collagen showed no difference. There were no severe side effects for the ArteFill group while the control group had ten severe side effects. The side effects of the control collagen group were similar to the side effects these products have shown for 15 years in the United States.
One month after treatment, both ArteFill and the control collagen had a similar effect on improving the wrinkle. At the 3 month evaluation, ArteFill maintained its effect while the control collagen had a lesser effect. At the 6 month evaluation, ArteFill had maintained its effect while the control group had lost its effect. This was the primary point at which effectiveness was determined. ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction.Is ArteFill safe?
Yes. The FDA has approved ArteFill for the safe and effective correction of smile lines.
Why is a skin test necessary prior to treatment with ArteFill?
A skin test is a safety precaution to make sure that you are not allergic to the bovine collagen or anesthetic in ArteFill.Are there any possible side effects with ArteFill?
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 3 to 7 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.
Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area.For complete product and safety information, please see ArteFill Instructions for Use
How does an ArteFill treatment compare to temporary fillers?
The treatment itself is similar. It involves injections with a fine needle and takes only a few minutes. You can resume your normal activities immediately.
When will I see results with ArteFill, and how long will the results last?
You will see results immediately. In the U.S. clinical study, full wrinkle correction was maintained throughout the study.
Is one treatment enough to get the look I want?
Most people get the results they want with 1 or 2 treatments, depending on the depth of their wrinkles and folds. When you have your follow-up appointment in 4 to 6 weeks, you and your doctor can decide if you would like to further enhance your results. With ArteFill Progressive Enhancement™, your doctor will tailor your treatment program to meet your individual needs. This personalized approach helps to ensure that you get the look you desire.
Ready to Schedule your ArteFill Treatment? Contact us.
Laser, Beauty and Wellness Center also offers Acne Treatment, Restylane, Juvederm, Photorejuvenation, Laser Hair Removal and Microcurrent holistic approach.
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