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IMPORTANT SAFETY INFORMATION FOR REVANESSE® 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 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 (32.0% Revanesse Versa +, 31.0% Revanesse Versa), swelling (21.0% Revanesse Versa +, 17.0% Revanesse Versa), and pain (17.0% Revanesse Versa +, 21.0% Revanesse Versa).

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.

Patient Assistance Information:

If you require immediate assistance, please contact your health care provider. For further assistance, please contact Prollenium Medical Technologies Inc. at 1-866-353-3017 (24 hours a day).

For more information about Revanesse Versa+, please see the Directions for Use or speak to your health care provider.