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.

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.

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.

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.