Directions For Use For Revanesse^® Versa^TM

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, 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.

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.

Caution: Federal Law restricts this device to sale by, or on the order of, a physician or properly licensed practitioner.

Indications for Use:  Revanesse Versa is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults 22 years of age or more.

Contraindications:

Revanesse Versa is only intended for intradermal use and must not be injected into blood vessels. Implantation of Revanesse Versa into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena.

Revanesse Versa contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.

Do not inject Revanesse Versa into eye contours. Serious adverse events have been reported related to the use of dermal fillers in the area of the eye.

This product has not been evaluated in pregnant women, or women during lactation, and these individuals should not be treated with Revanesse Versa.

Patients who develop hypertrophic scarring or keloid formation should not be treated with Revanesse Versa.

Patients with evidence of scars at the intended treatment sites should not be treated with Revanesse Versa.

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.

People under the age of 22 should not be treated with Revanesse Versa.

Patients with acne and / or other inflammatory diseases of the skin should not be treated with Revanesse Versa.

Patients with unattainable expectations.

Patients with multiple severe allergies, allergic history including anaphylaxis, atopy, hyaluronic acid products, Streptococcal proteins or have plans to undergo desensitization therapy during treatment with Revanesse Versa should not use the product.

Revanesse Versa should not be used in patients with acute or chronic skin disease in or near the injection sites, or with any infection or unhealed wound of the face.

Individuals who are under concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders, coagulation defects or connective tissue disorders should not use this product.

Warnings and Precautions:

Revanesse Versa should not be used in areas that have high vascularity as there is a risk of vascular embolization. There are published reports of dermal filler use in the area of the eye resulting in ocular vessel occlusion (i.e., blindness).

Avoid the use of Revanesse Versa when there is an active inflammatory process until the process has resolved. Injection site reactions have been observed, and are short term in duration.

All injections / transcutaneous procedures carry the risk of infection.

Dermal fillers have an inherent risk of keloid formation and hyperpigmentation at the injection site.

Patients historically prone to these conditions should avoid dermal fillers.

If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color. Blanching may represent a vessel occlusion. If normal skin coloring does not return, do not continue with the injection. Treat in accordance with American Society for Dermatologic Surgery guidelines, which include hyaluronidase injection.

Warning: Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.

Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.

In order to minimize the risks of potential complications, this product should only be used by health care practitioners who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection.

Health care practitioners are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.

Revanesse Versa should not be mixed with any other products before implantation.

It is imperative that Revanesse Versa patients with adverse inflammatory reactions that persist for more than one week report this immediately to their doctor. Please contact the company Prollenium Medical Technologies immediately at 1-877-202-0987.

Adverse Events

The most frequently reported injection-site TEAEs, reported for ≥5% of subjects with either treatment, were injection site hematoma (50.3% with Revanesse Versa, 47.2% with Comparator), injection site swelling (47.2% with Revanesse Versa, 71.2% with Comparator), injection site pain (38.0% with Revanesse Versa, 66.3% with Comparator) and injection site erythema (21.5% with Revanesse Versa, 31.9% with Comparator).

For more information about Revanesse Versa, please see the Directions for Use.