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.
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.
In order to minimize the risk of potential complications, this product should only be used by healthcare practitioners who have appropriate training, experience and who are knowledgeable about the anatomy at and around the injection site.
You should minimize strenuous activity and avoid extensive sun or heat exposure for about 24 hours after treatment and until any swelling or redness has resolved.
Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take Em excesso 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.
To get more personalized information, the best thing to do is to schedule a consultation with a healthcare provider.
Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.
Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
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.
There are two unique formulations of Radiesse—Radiesse and Radiesse (+). If you and your provider agree that Radiesse is right for you, they’ll design a treatment plan based on your desired outcome.
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).
RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type.
Please see the Patient Information Guide available at for list of radiesse these events. Tell your health care provider about any side effects that bother you or do not go away.