You should not use RADIESSE® or RADIESSE® (+) if you have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder, or if you are pregnant or breastfeeding. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.
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.
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. RADIESSE® is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.
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.
Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE® may cause nodules, bumps or lumps in the back of the hand and can last up to 1 year.
To help avoid needle breakage, do not attempt to straighten a bent needle or cannula. Discard it and complete the procedure with a replacement needle.
To help avoid needle breakage, do not attempt to straighten a bent needle or cannula. Discard it and complete the procedure with a replacement needle.
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. The treating physician should be knowledgeable regarding any pretreatment evaluation and appropriate interventions in the event of intravascular disseminated injection. Prompt intervention by an appropriate medical specialist should be given should these signs or symptoms of intravascular injection occur.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes.
The safety and effectiveness for use in the lips has not been established. There have been published reports of nodules associated with the use of these products injected into the lips.
Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.
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.
As with all transcutaneous radiesse procedures, injection of these products carries a risk of infection. Injection in the jawline may temporarily alter jaw function.
RADIESSE® and RADIESSE® (+) are dermal fillers that are used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth).
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