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Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra 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.

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 pelo 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.

Interactions between RADIESSE® or RADIESSE® (+) and drugs or other substances or implants Use during pregnancy, or in breastfeeding women

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 botox adverse event).

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® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type.

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.

Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.

Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site.

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.

The safety and effectiveness of RADIESSE® or RADIESSE® (+) in the following situations has not been established: