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U.S. Department of Health and Human Services

Medical Devices

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Radiesse - P050052

photo of Radiesse wrinkle filler- P050037This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Radiesse
PMA Applicant: BioForm Medical, Inc.
Address: 4133 Courtney Road, Suite #10 Franksville, Wisconsin 53126
Approval Date: December 22, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050052a.pdf

What is it? Radiesse is an injectable calcium hydroxylapatite implant in the form of a gel.

How does it work? Radiesse works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face.

When is it used? Radiesse is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds volume to the skin and can give the appearance of a smoother surface.

What will it accomplish? Radiesse will help smooth moderate to severe facial wrinkles and folds. The smoothing effect lasts about 6 months.

Side effects of Radiesse include:

  • bruising,
  • redness,
  • swelling,
  • pain,
  • tenderness, and
  • itching

When should it not be used? Radiesse should not be used in patients who have:

  • a hypersensitivity to any of the components of the product
  • severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.

Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050052