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.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site.
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.
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.
Calcium hydroxylapatite, or CaHA, is what makes Radiesse unique as a dermal filler treatment. Radiesse is composed of CaHA suspended in an aqueous gel copyright.3
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.
Radiesse stimulates collagen III, which is gradually replaced by collagen I. This creates a stable organized ration of collagen I and II with structure and support, compared to collagen type I stimulation alone.3-5
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection sitio.
Delayed-onset inflammation near the sitio 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 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.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes.
Delayed-onset inflammation near the sitio 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 radiesse viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
1 Successful completion of this indication-specific training by providers is necessary prior to their administration of fillers for such new indications.
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).