This is a brief overview of information related to the 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 the FDA’s approval.

Product Name: RADIESSE (+) Lidocaine Injectable Implant
PMA Applicant: Merz North America, Inc.
Address: 6501 Six Forks Road, Raleigh, NC 27615 USA
Approval Date: September 1, 2021
Approval Letter: Approval Order

What is it?

The RADIESSE (+) Lidocaine Injectable Implant is a gel implant, or dermal filler used in specific areas of facial tissue to reduce the appearance of lines and wrinkles. It consists of the chemical calcium hydroxylapatite (CaHa) and 0.3% (weight by volume, or w/v) of the drug lidocaine hydrochloride as a numbing agent.

This approval expands the indications for use of the RADIESSE (+) Lidocaine Injectable Implant to include injection into deep layers of the facial tissue (subdermal and/or supra-periosteal) to improve the outline (contour) of the jawline.

How does it work?

A doctor (dermatologist or plastic surgeon) injects the RADIESSE (+) Lidocaine Implant into the subdermal and/or supra-periosteal layers of the face to temporarily improve the jawline contour.

When is it used?

The RADIESSE (+) Lidocaine Injectable Implant is indicated for use to improve the jawline contour of adults 21 years of age and older.

What will it accomplish?

The RADIESSE (+) Lidocaine Injectable Implant may help improve the contour of the jawline by adding temporary fullness. In a clinical study, patients needed one or two treatments with multiple injections to achieve the best outcome. The results may last up to 12 months.

Side effects of the RADIESSE (+) Lidocaine Injectable Implant include:

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

When should it not be used?

The RADIESSE (+) Lidocaine injectable Implant is not for patients who have:

• Allergies to any of the ingredients, including lidocaine
• Allergies to any other local anesthetics, called “amide” type, such as bupivacaine or ropivacaine
• Bleeding disorders
• Multiple severe allergies
• Severe allergies that lead to anaphylaxis

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling
• Physician Labeling
• PMA Database Entry