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.
Please see the Patient Information Guide available at for list of these events. Tell your health care provider about any side effects that bother you or do not go away.
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.
Please see the Patient Information Guide available at for list of these events. Tell your health care provider about any side effects that bother you or do not go away.
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.
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).
Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.
These products are contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe bioestimulador de colágeno allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
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.
These products contain calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography.
It is important to remember not to overcorrect (overfill) a contour deficiency with Radiesse because the depression should gradually improve within several weeks as the treatment effect of Radiesse occurs.
RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type.
The safety and effectiveness of RADIESSE® or RADIESSE® (+) in the following situations has not been established: