• Some injectable implants have been associated with hardening of the tissue at the injection site, migration of particles from the injection site to other parts of the body and/or allergic or autoimmune reactions. Based on clinical usage, animal studies and supporting literature, this has not been observed nor is expected with RENÚ® injectable implant.
• 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.
• Special care should be taken to avoid injection into the blood vessels. An introduction into the vasculature may occlude the vessels and could cause vascular occlusion, hemolysis, platelet aggregation, embolic phenomena or infarction.
• Should not be injected into organs or other structures that could be damaged by space occupying implant.
• Do not overcorrect (overfill) a deficiency because the depression should gradually improve within several weeks as the treatment effect of RENÚ® injectable implant occurs (see INDIVIDUALIZATION OF TREATMENT).
• Safety and efficacy of RENÚ® injectable implant during pregnancy or in lactating females has not been established.
• With any implant materials, possible adverse reactions that may occur include, but are not limited to the following: Inflammation, infection, fistula formation, inadequate healing, skin discoloration, reported in the literature:
Vocal fold paralysis, breathing difficulty, swelling of throat, implant extrusion, poor phonatory function post injection, permanent hoarseness due to injection due to inadequate or excessive augmentation.
• 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.
Important: For full safety information, please see the product IFU or call RegenScientific Customer Service at 855-433-2765
RENÚ® is available through licensed physicians only.