As with all transcutaneous procedures, injection of these products carries a risk of infection. Injection in the jawline may temporarily alter jaw function.
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.
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.
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.
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.
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.
The safety and effectiveness liftera of RADIESSE® or RADIESSE® (+) in the following situations has not been established:
Cases of delayed-onset inflammation have been reported to occur at the dermal filler treatment sitio following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
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.
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.
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.