Rockville, Md. — The Food and Drug Administration's General and Plastic Surgery Devices Panel voted 5-2 in late August to recommend approval of two aesthetic indications for Radiesse (BioForm Medical.)
BioForm Medical is seeking approval for the device's use for correcting facial lipoatrophy in HIV-positive patients and for correcting facial lines and wrinkles.
Radiesse was previously approved by the FDA for oral/maxillofacial augmentation, vocal fold augmentation and radiographic tissue marking, and it is marketed outside the United States for facial soft tissue augmentation.Advisory panel recommendations, though not binding, are typically followed by full FDA approval.
Beginning on Page 12 of this issue, Cosmetic Surgery Times features in-depth coverage of other dermal fillers in the pipeline.