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Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Bellafill is indicated for the correction of nasolabial folds. Go to link

Actual Bellafill patient photos. Bellafill is indicated for the correction of nasolabial folds. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Actual Bellafill patient photos. Go to link

Q: WHAT IS BELLAFILL?

A: Bellafill is an injectable filler for the correction of wrinkles known as smile lines. It contains 20% tiny round, non-resorbable and smooth particles (PMMA microspheres) and 80% purified bovine collagen gel with 0.3% lidocaine, an anesthetic.

Q: HOW IS BELLAFILL DIFFERENT FROM TEMPORARY DERMAL FILLERS?

A: All temporary fillers are eventually absorbed by the body. That’s why they require frequent repeat injections. Bellafill is different. The unique microspheres in Bellafill are not absorbed by the body. These microspheres provide the support your skin needs for wrinkle correction.

Q: HOW DOES BELLAFILL WORK?

A: Bellafill is a dual-acting injectable wrinkle filler. First, Bellafill visibly corrects the wrinkle. Then the microspheres provide the support your skin needs for wrinkle correction.

Q: IS BELLAFILL SAFE?

A: Yes. The FDA has approved Bellafill for the safe and effective correction of smile lines.

Q: WHY IS A SKIN TEST NECESSARY PRIOR TO TREATMENT WITH BELLAFILL?

A: A skin test is a safety precaution to make sure that you are not allergic to the bovine collagen or anesthetic in Bellafill.

Q: HOW IS BELLAFILL INJECTED?

A: Bellafill is injected underneath the wrinkle, just above the skin’s fat layer. Bellafill provides the soft, supportive foundation that your skin needs for wrinkle correction.

Q: CAN ANYONE HAVE BELLAFILL TREATMENTS? (CONTRAINDICATIONS)

A: No.

Some people are not good candidates for Bellafill. Bellafill is contraindicated in those who: • have a positive reaction to the Bellafill skin test. • have a history of severe allergies and hypersensitivity (anaphylaxis). • are allergic to the anesthetic (lidocaine) in Bellafill. • 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.

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 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.

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. • 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.

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

Q: HOW DOES ARTEFILL TREATMENT COMPARE TO TEMPORARY FILLERS?

A: 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.

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 throughout the study.

Q: WHAT CLINICAL STUDIES WERE CONDUCTED ON ARTEFILL?

A: Suneva 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. The effectiveness of ArteFill and the control collagen to correct smiles lines (nasolabial folds) is shown in Figure 2. 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.

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 and your doctor can decide if you would like to further enhance your results. With ArteFill Progressive Enhancement™ (gradual wrinkle correction), your doctor can tailor your treatment program to meet your individual needs. This personalized approach helps to ensure that you get the look you desire.

Q: WHERE CAN I GET ARTEFILL TREATMENT?

A: ArteFill is only available through ArteFill-trained physicians. To find an ArteFill-trained doctor near you, please visit www.artefill.com or call 888. ARTEFILL (888.278.3345).

For more information and to locate an ArteFill-trained physician in your area, visit www.artefill.com. 5870 Pacific Center Blvd. San Diego, CA 92121 United States of America 888.ARTEFILL (888.278.3345) 858.550.9999 info@sunevamedical.com www.sunevamedical.com Reference ArteFill Instructions for Use. San Diego, CA 92121 ©2013 Suneva Medical, Inc. Before and after photos are ArteFill patients.

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