Safe, biocompatible, non-toxic, and non-antigenic

Radiesse® dermal filler is safe, biocompatible, non-toxic, and non-antigenic. It has received CE mark certification for plastic and reconstructive surgery, including soft tissue augmentation of the facial area, and vocal fold insufficiency. In the United States, it is FDA-approved for the correction moderate to severe facial wrinkles and folds, for the correction of the signs of facial lipoatrophy in HIV patients. In addition, there are US FDA clearances for oral/maxillofacial defects, vocal fold insufficiency, and radiographic tissue marking.

Bioidentical Composition

RADIESSE dermal filler consists of calcium hydroxylapatite (CaHA) microspheres suspended in a carboxymethylcellulose gel carrier. Years of rigorous industry and independent experience with more than 150,000 patients worldwide has consistently proven that CaHA microspheres are safe and biocompatible.

The CaHA in RADIESSE dermal filler is identical in its molecular and chemical composition to that found in the human body. Also, no granulomas have been reported in more than 1,000 patients studied.

Safe During & After Treatment

There have been very few side effects reported in clinical trials and actual usage. However, some common injection-related reactions could occur, such as edema, swelling, pain, itching, discoloration, and tenderness at the injection site. These conditions typically resolve on their own within one to two days.

RADIESSE dermal filler is not obstructive in X-rays. It will not migrate to other parts of the body after injection.

While RADIESSE dermal filler is long-lasting, it is not permanent. In the body, CaHA microspheres degrade to calcium and phosphate ions over time via normal metabolic processes.

Rigorous Clinical Testing

To verify the safety and longevity of treatment with RADIESSE dermal filler, BioForm Medical has conducted clinical trials in Europe and North America. Through extensive clinical trials published in peer-reviewed journals, treatment has been proven to be safe, effective, and long-lasting.

BioForm Medical has conducted extensive safety studies with RADIESSE dermal filler and sister products incorporating CaHA microspheres, including:

• Numerous FDA multicenter clinical studies
• Toxicology assessments
• Standardized biocompatibility testing