7/25/2023 0 Comments Define viscosity and elasticityThere have been published reports of nodules associated with the use of these products injected into the lips. The safety and effectiveness for use in the lips has not been established. RADIESSE ® may cause nodules, bumps or lumps in the dorsum of the hand (12% reported this event) and can last up to 1 year. Injection into the dorsum of the hand may cause adverse events that last for more than 14 days, and may result in temporary difficulty performing activities (48% of study patients reported this adverse event). Use of these products in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled.ĭo not overcorrect (overfill) a contour deficiency with these products. Prompt intervention by an appropriate medical specialist should be given should these signs or symptoms of intravascular injection occur. The treating physician should be knowledgeable regarding any pretreatment evaluation and appropriate interventions in the event of intravascular disseminated injection. 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. 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. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type. These products are contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies patients with known hypersensitivity to any of the components and patients with bleeding disorders. RADIESSE ® and RADIESSE ® (+) IMPORTANT SAFETY INFORMATION: RADIESSE (+) injectable implant is also indicated for deep injection (subdermal and/or supraperiosteal) for soft tissue augmentation to improve moderate to severe loss of jawline contour in adults over the age of 21. RADIESSE® is also indicated for hand augmentation to correct volume loss in the dorsum of the hands. Radiesse © and Radiesse © (+) Injectable Implants are FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
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