IMPORTANT RADIESSE®, RADIESSE® (+), and BELOTERO BALANCE® SAFETY INFORMATION
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. BELOTERO BALANCE® Injectable Implant is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
RADIESSE® and BELOTERO BALANCE® should not be used in patients with bleeding disorders or in patients with severe allergies manifested by a history of anaphylaxis, or with a history or presence of multiple severe allergies. RADIESSE® should not be used in patients with a history of hypersensitivity to any of the components; and patients with bleeding disorders. RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type. BELOTERO BALANCE® contains trace amounts of gram-positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Common adverse events seen in the clinical study of RADIESSE® injected in the hand include bruising, redness, swelling, pain, itching, nodule or lumps/bumps, difficulty performing activities, and loss of sensation. Common adverse events seen in clinical studies of RADIESSE® and RADIESSE® (+) injected in the face include bruising, redness, swelling, pain, and itching.
The most common adverse events seen in clinical studies with BELOTERO BALANCE® were swelling, bruising, redness, hardening of the skin, pain, altered color or itching. Side effects were often mild to moderate and often resolved within 7 days. These are not all the possible side effects with BELOTERO BALANCE®.
For complete safety information, including information on adverse events from post-market surveillance of RADIESSE®, RADIESSE® (+), and BELOTERO BALANCE®, please refer to the Instructions for Use at www.radiesse.com and www.belotero.com. To report a problem with RADIESSE®, RADIESSE® (+), or BELOTERO BALANCE®, please call MyMerz Solutions at 1-844-469-6379.
RADIESSE® is available only through licensed physicians.
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