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.
RADIESSE® is also used for correcting volume loss in the back of the hands. RADIESSE® (+) is also used for improving moderate to severe loss of jawline contour in adults over 21 years old.
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).
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
Histology slides demonstrate deposition of new collagen around CaHA microspheres over an extended period of time. Collagen fibers stain red, while other tissue elements appear more yellow.
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.
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.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection sitio.
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 may be visible in standard, plain radiography.
Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment sitio following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to liftera treatment or resolved on its own.
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 of RADIESSE® or RADIESSE® (+) in the following situations has not been established: