What it is:
ArteFill® is a permanent filler that is used for correcting deep nasiolabial folds, which are among the first sings of aging. The safe, simple procedure has immediate results, no down time, and results improve over time.

How it works:
ArteFill® works similarly to dermal fillers like Restylane, but since it is a collagen gel, the filler is not absorbed into the body over time. That means results are permanent, and typically only one or two treatments are required to produce lasting results. The gel fills and corrects the wrinkle, while its PMMA microspheres provide your skin with permanent support for long-lasting wrinkle correction.

What Laura says:
“Once I used ArteFill®, I immediately fell in love with it. It goes in like lotion, and you can see the results immediately! Since it is a permanent filler, I always tell patients to try a semi-permanent filler like Restylane first. This is fairly new, and at the moment we’re only using ArteFill® for the nasiolabial folds. It’s better for people who want to correct deep wrinkles – it ’s not for people with faint lines – but we’ve seen dramatic results when we use it.”

Concerns & Considerations:
This is a permanent treatment, so make sure that you have used semi-permanent fillers and like the results before trying Restylane. Your skin must be tested four weeks before your initial ArteFill® treatment to ensure there are no allergies to bovine collagen. It should be postponed if you are on any kind of immuno-suppressive therapy or if you have any skin outbreaks near the injection sites.

Frequenty Asked Questions

What is ArteFill®?
ArteFill®, the first and only FDA-approved non-resorbable injectable wrinkle filler for the correction of facial 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 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.

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.

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®.

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.

Can anyone have ArteFill® treatments?
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 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 bovine 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.

Are there any other treatment concerns with ArteFill®?
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 your doctor if:
If you have any skin outbreaks (e.g., cysts, pimples, rashes, hives, infection) near the injection site, you should postpone treatment until they clear. 

• you have had any treatments for smile lines in the last 6 months.

• you are receiving UV light therapy.

• you are currently on immuno-suppressive therapy (medication commonly prescribed for those who have undergone an organ transplant, or are suffering from rheumatoid arthritis, psoriasis, inflammatory bowel disease, or cancer).

It’It's important that you share your medical information with your doctor. Together, you can make an informed decision as to whether ArteFill® is right for you.

Are there any further precautions with ArteFill®?
Yes, you should know:

• ArteFill® contains microspheres that help provide the permanent support for wrinkle correction. Treatment results are lasting. The microspheres can only be surgically removed.

• The safety of ArteFill® in pregnant or breastfeeding women, and individuals under 18, has not been established.

• There is always a risk of infection with any injection. Discuss the symptoms of infection with your doctor so you will be able to recognize them.

• Check to see if your doctor is properly trained to provide 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.

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.

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.  

Nasolabial Fold Improvement