How Artefill Works to
Correct Wrinkles

You can locate  licensed physicians within your area that are trained and currently using the product by clicking here. You can also contact us at 1-888-ARTEFILL (888-278-3345) or info@artefill.com.

Artefill is the long lasting solution for wrinkle correction. Artefill consists of a combination of microsphere enhanced collagen and lidocaine for comfort.

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.

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.

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.

Many physicians and patients desire a longer lasting wrinkle filler due to the time and cost
associated with temporary fillers. Artefill represents an ideal solution for those patients who
do not want to return for repeat treatments for temporary dermal fillers.

Artefill is made up of microsphere enhanced collagen and lidocaine for injection comfort.

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

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:

• 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)

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.

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
• 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

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.

Be sure to call your doctor immediately if you notice any unusual skin reactions around the
treatment area.

You will see results immediately. In the U.S. clinical study, full wrinkle correction was maintained for up to one year.

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 and your doctor can decide if you would like to further enhance your results.

The tiny microspheres in Artefill are made of polymethylmethacrylate (PMMA), one of the most widely used synthetic implant materials in medicine.  The microspheres in Artefill remain intact at the injection site and provide structural support to keep your wrinkle from returning.

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 microspheres. These findings concluded that the collagen is absorbed while the body’s natural collagen surrounds the microspheres and holds them in place, providing long lasting wrinkle correction.

With proper placement, Artefill cannot be felt after treatment. You will see the results immediately and be able to return to your normal daily activities.

Studies have shown that patients injected with microsphere-enhanced collagen five years from their initial treatment still reflect a natural appearance in both their overall facial appearance as well as in the area treated. These patients were surveyed and had a very high satisfaction rate related to their wrinkle correction and experience with their treatment.

The skin test is a safety precaution to ensure that you are not allergic to the collagen or anesthetic in Artefill.

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.

Artefill represents the next generation of this PMMA-based dermal filler technology. Artefill has been FDA approved since October 2006, however, Artecoll is not approved by the FDA for use in the U.S.

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.

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 years post-treatment.

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.

To date, thousands of patients in the U.S. have been treated successfully with Artefill.

Persistent lumps are a rare potential side effect of all dermal fillers, including Artefill, and can be treated effectively.

Yes, an Artefill skin test is required prior to treatment to make sure that you are not allergic to the collagen in Artefill.