Combination Contour

VOLUMA®

• First and only HA filler FDA-approved to instantly add volume to the cheek area.
• Subtle lift.
• Clinically proven to last up to 2 years.
• Resume normal activities after 24 hours.

BELLAFILL®

JUVÉDERM®

• Juvederm can improve several areas, including:
• Deep folds on the sides of the mouth - nasolabial folds.
• Deep folds below the corners of the mouth - marionette lines.
• Lip borders, vertical lip lines and wrinkles.
• Corners of the mouth - drooping corners are uplifted.
• Thinning lips - lip enhancement.
• Earlobes.

• Natural Results.
• Long Lasting.
• Less Swelling.

VOLUMA®

What is JUVÉDERM VOLUMA® XC?

As you age, the cheeks may flatten and the skin may begin to sag. This is caused by natural loss of volume in the cheek area, or what the experts call age-related midface volume loss. JUVÉDERM VOLUMA® XC is designed to add volume beneath the skin's surface, which provides lift and contour to the cheek area.

What are the potential side effects of JUVÉDERM VOLUMA® XC?

The most common side effects included temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Side effects were moderate (uncomfortable), and generally lasted 2 to 4 weeks. As with all skin injection procedures, there is a risk of infection.

How does JUVÉDERM VOLUMA® XC work?

Over time, the cheeks flatten, and the skin may begin to sag. This is caused by natural loss of volume in the cheek area, or what the experts call age-related midface volume loss. JUVÉDERM VOLUMA® XC is designed to add volume beneath the skin's surface, which provides lift and contour to the cheek area.

BELLAFILL®

Are there other dermal fillers on the market with FDA approval to treat acne scars?

No, Bellafill® is the only FDA-approved dermal filler, on the market, for the correction of atrophic (pitted), distensible facial acne scars on the cheek. No other dermal filler on the market is approved for the treatment of acne scars.

What is Bellafill®‘s indication for use?

Bellafill® is the only dermal filler FDA approved for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. It is also the only dermal filler established safe and effective for nasolabial fold correction through 5 years.

How long does Bellafill® last?

Satisfaction and effectiveness for the correction of nasolabial folds have been established through 5 years. Effectiveness for the correction of acne scars has been proven through 12 months.

Is there a current demand for effective acne scar treatments?

Yes. Millions of Americans suffer from acne and billions of dollars are spent each year on treatments. Furthermore, a significant number of acne sufferers go on to develop devastating scarring. Physician and patient market research shows relatively low satisfaction with many available treatments with patients having to make trade-offs between efficacy, longevity, safety, downtime, and cost. Now with Bellafill®, acne scar sufferers have a new treatment choice that is proven to be safe and effective with minimal to no downtime.

What is the physical and emotional impact of acne scars?

Acne is the most common skin disorder in the U.S., affecting up to 40–50 million Americans. A significant number of acne sufferers go on to develop devastating scarring. Physician and patient market research shows relatively low satisfaction with many treatments, and patients having to make trade-offs between efficacy, longevity, safety, downtime, and cost.

Scars are more than skin deep, and have been shown to cause high levels of anxiety and self-consciousness. In an independent study 92% of people said if their acne scars were healed, it would restore or improve their self-confidence.

Now with Bellafill®, acne scar sufferers have a new treatment choice, approved by the FDA, that is proven to be safe and effective with minimal to no downtime.

What is the difference between Bellafill® and ArteFill®?

Bellafill® is the new name for ArteFill® in North America. It is distributed under the trade name ArteFill® in South Korea and Singapore. ArteFill® was rebranded to Bellafill® in the U.S. to reflect the transformational outcomes this unique product can provide to patients seeking correction of their acne scars and nasolabial folds. In markets outside of the U.S., the product is only approved for nasolabial folds.

What kind of research has been done to determine acne scar effectiveness?

A pivotal, randomized, double-blinded, placebo-controlled study was conducted to evaluate the effectiveness and safety of Bellafill® for treating moderate to severe, atrophic, distensible facial acne scars on the cheek. Subjects were randomized to Bellafill® vs. saline injections. Bellafill® was found to be a safe and effective treatment when compared to control treated subjects.

This study maintained a high threshold for success: the primary effectiveness endpoint defined a responder as a subject who had 50 percent or more of treated acne scars, improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). This six month endpoint was met with statistical significance and, as a secondary endpoint, continued to show improvement at nine and 12 months when assessed by the un-blinded investigator. Subjects blinded to treatment also reported successful outcomes and demonstrated improvement in their global appearance after treatment with Bellafill®.

When did Bellafill® receive FDA approval for the treatment of acne scars?

Bellafill® received FDA approval for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years in December 2014.

How long has Bellafill® been available in the U.S.?

Bellafill® was FDA approved in October 2006 (under the name ArteFill®) for treating nasolabial folds (smile lines). In December 2014, Bellafill® was approved by the FDA for the correction of atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.

RADIESSE®

What is RADIESSE®?

RADIESSE® is an opaque, white colored dermal filler made up of CaHA microspheres in a water based gel injected into the skin of the face to smooth away wrinkles such as the lines from your nose to the corners of your mouth (nasolabial folds). RADIESSE® is nonanimal based and free from animal protein. Before you are injected, you do not have to be tested to see if you are allergic to RADIESSE®.

What is RADIESSE® used for?

RADIESSE® is injected into your skin to smooth away wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds).

How does it work?

RADIESSE® is injected into the skin with a thin needle to plump the skin and add volume to smooth facial wrinkles and folds such as the lines from your nose to the corners of your mouth. Your doctor will inject the product into your skin to make the wrinkles shallower and smoother. RADIESSE® will not correct the underlying causes of wrinkles and folds.

Are there any reasons why I should not receive RADIESSE®?

Your doctor will ask about your medical history to determine if you are a good candidate for injection of RADIESSE®. In order to avoid complications and unsatisfactory results, RADIESSE® should not be used if:

• You have severe allergies marked by a history of severe reaction (anaphylaxis) or history or presence of severe allergies. Use may result in an allergic reaction.
• You have had a severe reaction (hypersensitivity) to any of the components (CaHA, sterile water, carboxymethylcellulose, glycerin). Use may result in an allergic reaction.
• You have a bleeding disorder.

What are some Warnings to consider? 

It is important to share your medical information with your doctor. Together you can make an informed decision as to whether or not RADIESSE® is right for you. Because use could result in significant injury, RADIESSE® should not be used in the following cases:

• Warning: One of the risks of using RADIESSE® is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness or confusion), white appearance of the skin or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately. 
• RADIESSE® should not be used in any person with active skin inflammation or infection in or near the treatment area until the inflammation or infection has been controlled.
• The safety and effectiveness of RADIESSE® for use in the lips has not been established. Use in the lips may result in unsatisfactory results and injury such as the formation of nodules (small lumps of dermal filler material).
• Injection procedure reactions have been observed consisting mainly of short-term (i.e. < 7 days) bruising, redness and swelling.

JUVÉDERM®

What is JUVÉDERM® ULTRA XC?

JUVÉDERM® ULTRA XC is an injectable gel that temporarily adds more fullness and plumps thin lips—whether your lips have thinned over time or you simply want fuller lips-in adults over the age of 21. JUVÉDERM® ULTRA XC is also approved for smoothing and correcting moderate to severe parentheses lines, such as nasolabial folds (smile lines around the nose and mouth), in adults.

How long does JUVÉDERM® ULTRA XC last?

JUVÉDERM® ULTRA XC lasts up to one year, with optimal correction.

What are the potential side effects of JUVÉDERM® ULTRA XC?

For lip augmentation, most side effects were mild or moderate in nature with duration of 14 days or less. The most common side effects were temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps,and bruising.

For treating lines and wrinkles, most side effects were mild or moderate in nature with duration of 7 days or less. The most common side effects included temporary injection-site reactions such as redness, pain/tenderness, firmness, selling, lumps/bumps, bruising, itching, and discoloration.

How does JUVÉDERM® ULTRA XC work?

JUVÉDERM® ULTRA XC temporarily adds volume to facial tissue and restores a smoother appearance to the face. The lidocaine in the gel improves the comfort of the injection.

Also, JUVÉDERM® ULTRA XC temporarily adds fullness for lip enhancement in adults over the age of 21.

VOLUMA®

What is JUVÉDERM VOLUMA® XC?

As you age, the cheeks may flatten and the skin may begin to sag. This is caused by natural loss of volume in the cheek area, or what the experts call age-related midface volume loss. JUVÉDERM VOLUMA® XC is designed to add volume beneath the skin's surface, which provides lift and contour to the cheek area.

What are the potential side effects of JUVÉDERM VOLUMA® XC?

The most common side effects included temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Side effects were moderate (uncomfortable), and generally lasted 2 to 4 weeks. As with all skin injection procedures, there is a risk of infection.

How does JUVÉDERM VOLUMA® XC work?

Over time, the cheeks flatten, and the skin may begin to sag. This is caused by natural loss of volume in the cheek area, or what the experts call age-related midface volume loss. JUVÉDERM VOLUMA® XC is designed to add volume beneath the skin's surface, which provides lift and contour to the cheek area.

JUVÉDERM®

What is JUVÉDERM® ULTRA XC?

JUVÉDERM® ULTRA XC is an injectable gel that temporarily adds more fullness and plumps thin lips—whether your lips have thinned over time or you simply want fuller lips-in adults over the age of 21. JUVÉDERM® ULTRA XC is also approved for smoothing and correcting moderate to severe parentheses lines, such as nasolabial folds (smile lines around the nose and mouth), in adults.

How long does JUVÉDERM® ULTRA XC last?

JUVÉDERM® ULTRA XC lasts up to one year, with optimal correction.

What are the potential side effects of JUVÉDERM® ULTRA XC?

For lip augmentation, most side effects were mild or moderate in nature with duration of 14 days or less. The most common side effects were temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps,and bruising.

For treating lines and wrinkles, most side effects were mild or moderate in nature with duration of 7 days or less. The most common side effects included temporary injection-site reactions such as redness, pain/tenderness, firmness, selling, lumps/bumps, bruising, itching, and discoloration.

How does JUVÉDERM® ULTRA XC work?

JUVÉDERM® ULTRA XC temporarily adds volume to facial tissue and restores a smoother appearance to the face. The lidocaine in the gel improves the comfort of the injection.

Also, JUVÉDERM® ULTRA XC temporarily adds fullness for lip enhancement in adults over the age of 21.

BELOTERO BALANCE®

See FAQs on the BELOTERO BALANCE website

VOLBELLA®

Are there any reasons why I should not receive JUVÉDERM VOLBELLA® XC injectable gel?

Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins used in these products.

What precautions should my doctor advise me about?

• Tell your doctor if you are pregnant or breastfeeding. The safety of JUVÉDERM VOLBELLA® XC for use during pregnancy or while breastfeeding has not been studied
• The safety of JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
• The safety and effectiveness of JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in controlled clinical studies
• Tell your doctor if you have a history of excessive scarring (e.g., hypertrophic scarring and keloid formation) or pigmentation disorders, as use of JUVÉDERM VOLBELLA® XC may result in additional scars or changes in pigmentation
• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
• Tell your doctor if you are on immunosuppressive therapy used to decrease the body's immune response, as use of JUVÉDERM VOLBELLA® XC may result in an increased risk of infection
• Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

What are possible side effects?

The most common side effects include swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, and itching. Most side effects are mild or moderate and last 30 days or less.

One of the risks with using this product is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

As with all skin injection procedures, there is a risk of infection.

VERSA

What is Revanesse Versa?

Revanesse Versa is hyaluronic acid dermal filler. Hyaluronic acid is a naturally occurring substance that is found within the body. It may be produced by bacteria and purified for use as injectable soft tissue filler in order to correct the appearance of facial wrinkles and creases, (nasolabial folds). The product is approved for use in the U.S. by the Food and Drug Administration for the cosmetic treatment of facial wrinkles and creases.

Are there any warnings I should be aware of?

If you have an adverse inflammatory reaction, such as redness, pain and swelling that persist for one week or more after treatment with Revanesse Versa, you should report this immediately to your doctor. If you are under the age of 22 you should not be treated with Revanesse Versa.

Warning: One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.

Are there any reasons why I should not (contraindications) receive the Revanesse Versa injection?

You should not be treated with Revanesse Versa if you:

• are pregnant or breastfeeding, as the safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
• have a history of hypertrophic scarring or keloid formation
• have evidence of scars at the intended treatment sites
• have acne and / or other inflammatory diseases of the skin, such as rosacea, seborrheic dermatitis, and psoriasis,
• have allergic history including:
  • severe allergic reactions (anaphylaxis),
  • heightened immune responses to common allergens, especially inhaled allergens and food allergens (atopy),
  • allergy to natural rubber latex,
  • allergy to hyaluronic acid products,
  • Streptococcal proteins or have plans to undergo administration of graded doses of allergens (desensitization therapy) during treatment with Revanesse Versa.
• have acute or chronic skin disease, such as seborrheic dermatitis or rosacea, in or near the injection sites, or any infection or unhealed wound of the face
• are under concomitant anticoagulant therapy, antiplatelet therapy, or have a history of bleeding disorders, clotting disorders such as hemophilia or connective tissue disorders such as systemic lupus erythematosus

You should never use Revanesse Versa in conjunction with a laser, intense pulsed light, chemical peeling or dermabrasion treatments, or with Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks (28 days) prior to treatment, as there is a possible risk of inflammation at the treatment site if these procedures are performed before treatment.

What are the risks?

• Bleeding and Bruising: Bleeding is usually minimal and resolves within a few minutes. It is possible to have a bleeding episode from the injection of the local anesthesia or filler that requires treatment, but it is unusual. Bruising in the area is also an expected reaction and can take up to a week to resolve.
• Swelling: Swelling is also expected and may take several days to a week to resolve. It is unusual but medical treatment may be necessary if swelling is slow to resolve.
• Pain: Some discomfort is expected with injections but usually lasts less than a day.

Other risks that are less likely, but may occur, include the following: Acne-like skin eruptions, Skin sensitivity (rash, itching, tenderness), Skin infection, Damage to nerves or blood vessels, Skin lumpiness, Scarring, Skin necrosis (death of the skin), Hyperpigmentation (darkening of the skin), Reactivation of herpes infection (blisters or skin sores).

As with using any dermal filler, there is a risk of allergic reaction. If you have a very serious allergic reaction (anaphylactic shock) you may require emergency medical help and be at risk of death. Some symptoms of allergic reactions are: a rash, having a hard time breathing, wheezing when you breathe, sudden drop in blood pressure, swelling of the face, fast pulse, sweating, dizziness or fainting, inability to breathe without assistance, a feeling of dread.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities or blindness.

Side Effects:

Ask your doctor if you have questions about any of the side effects, and please tell your doctor or your doctor’s staff right away if you have any side effects. Please tell them if you have any other problems with your health or the way you feel, whether or not you think these problems are related to the products.

The most common side effects include: bruising, redness, swelling, pain, and itching.

You should seek immediate medical attention if you develop symptoms such as unusual pain, vision changes, a white appearance of skin near the injection site (blanching) or any other unexpected symptoms. While rare, unexpected symptoms include unusual pain, vision changes, or any signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, visual changes, face drooping, severe headache, dizziness, or confusion) during or shortly after the procedure.

Rare, but serious risks, of dermal fillers include: scarring, blurred vision, partial vision loss, and blindness if the dermal filler is inadvertently injected into a blood vessel. In occasionally rare cases, there have been reports of unintentional injection of the product into a blood vessel with dermal filler products. It is recommended that doctors take care to avoid injection into blood vessels (especially around the forehead, nose and eye area) for these reasons, allergic reaction that may lead to a severe reaction (anaphylactic shock) that requires emergency medical help.