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.
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.
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).
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.
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.
Injection in botox 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.
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.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes.
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.
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.