IMPORTANT SAFETY INFORMATION – PATIENTS

IMPORTANT SAFETY INFORMATION – PROVIDERS

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, allergy to natural rubber latex, 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 1-866-353-3015.

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.

For complete provider information about Revanesse®  VersaTM download the Directions for Use document for additional details.