RADIESSE® has been approved for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
RADIESSE® IMPORTANT CONSUMER SAFETY INFORMATION
RADIESSE Injectable Implants is FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds or correction of the signs of fat loss (lipoatrophy) in people with human immunotherapy virus.
RADIESSE is contraindicated for patients with severe allergies, known hypersensitivity to any of the components of RADIESSE and patients with bleeding disorders. Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Common adverse events seen in clinical studies of RADIESSE include bruising, redness, swelling, pain, and itching.
For complete safety information, including information on adverse events from post-market surveillance of RADIESSE, please refer to the Instructions for Use at Radiesse.com. To report a problem with RADIESSE, please call MyMerz Solutions at 1-844-469-6379.
Caution: Rx only
For Instructions for Use Document and Complete Safety Information please go to www.radiesse-fl.com or call My Merz Solutions at 1-844-469-6379.
1 Berlin AL, Hussain M, Goldberg DJ. Calcium hydroxylapatite filler for facial rejuvenation: a histologic and immunohistochemical analysis. Dermatol Surg. 2008;34(suppl 1):S64-S67.