Medical Devices

Radiesse Injectable Implant - P050052/S049

This 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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name:Radiesse Injectable Implant
PMA Applicant: Merz North America Inc.
Address: 4133 Courtney Road, Suite 10, Franksville, WI 53126
Approval Date: June 4, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050052s049a.pdf

What is it? The Radiesse Injectable Implant (Radiesse) is a white, sterile, injectable implant. Radiesse is a dermal filler that can increase volume in the back of the hand to reduce the appearance of veins and tendons due to volume loss. Radiesse consists of synthetic calcium hydroxylapatite particles suspended in a gel containing sterile water, glycerin and sodium carboxymethylcellulose.

How does it work? A doctor (dermatologist or plastic surgeon) injects Radiesse under the skin on the back of the hand (not the palm) to plump the skin. Radiesse adds volume to lessen the visibility of veins and tendons in the hand due to loss of volume.

When is it used? This new approval expands the approved uses for Radiesse to include improvement in the appearance in the back of the hand due to volume loss. This device is used in adults over the age of 21.

What will it accomplish? Radiesse temporarily improves the appearance of the back of the hand by adding volume to lessen the visibility of veins and tendons due to loss of volume. In a clinical study, patients needed one or two treatments with multiple injections to achieve the best outcome. The results may last up to one year.

Side effects of Radiesse include:

  • Bruising
  • Swelling
  • Redness
  • Itching
  • Pain/Tenderness
  • Hematoma
  • Bumps/Lumps
  • Difficulty in performing activities/stiffness
  • Loss of sensation

When should it not be used? (Contraindications)
Radiesse is not for patients who have:

  • Severe allergies with a history of anaphylaxis or a history or presence of multiple severe allergies.
  • A known hypersensitivity to any of the components.
  • Bleeding disorders.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Page Last Updated: 06/18/2015
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