As with all transcutaneous procedures, injection of these products carries a risk of infection. Injection in the jawline may temporarily alter jaw function.
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.
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.
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 these events. Tell your health care provider about any side effects that bother you or do not go away.
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.
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.
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 of RADIESSE® or RADIESSE® (+) in the following situations has not been established:
These products contain calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and sculptra may be visible in standard, plain radiography.
Tell your health care provider if you have any diseases, injuries or disabilities of the hand, if you have a history forming large, raised scars or if you have had any other skin treatments such as skin peels.
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.
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.