Is RADIESSE Safe and Effective

BioForm Medical, Inc. announced today that the U.S. Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Advisory Panel has recommended the approval of Radiesse, a next-generation soft tissue augmentation product, for use as a filler material to restore soft tissue facial contours such as nasolabial folds and for use in the correction of lipoatrophy of the face associated with HIV therapy.

The Panel recommended approval of Radiesse with conditions in both indications following the review of data from a premarket approval application (PMA) for Radiesse to be used as an injectable device intended for use in the correction of facial lipoatrophy associated with HIV therapy; and a second PMA for Radiesse to be used as a filler material to correct facial lines and wrinkles such as nasolabial folds. Radiesse is the first filler to obtain concurrent positive recommendations for use in two facial aesthetic applications.