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.
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® (+) 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.
Radiesse is injected under the skin in a minimally invasive procedure. Injection of the product provides an immediate and visible correction to the wrinkle. There is no skin sensitivity testing or reconstitution required.1
Cases of delayed-onset inflammation have been reported to occur at the dermal filler 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.
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.
CaHA particles form a “scaffold” that stimulates fibroblasts to produce collagen for up to a year and elastin for up to nine months (after only one injection).5-10
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 allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
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.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes.
Radiesse (+) treatments of jawline contour should only be administered by providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the sitio of injection.
As with all transcutaneous procedures, injection of these products carries a risk sculptra of infection. Injection in the jawline may temporarily alter jaw function.
The safety and effectiveness of RADIESSE® or RADIESSE® (+) in the following situations has not been established: