The Aesthetic Guide is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Radiesse gets FDA panel new use nod

Article-Radiesse gets FDA panel new use nod

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.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.