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U.S. Department of Health and Human Services

Medical Devices

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Belotero Balance - P090016

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: Belotero Balance
Applicant: Merz Pharmaceuticals, LLC
Address: 4215 Tudor Lane Greensboro, NC 27410
Approval Date: November 14, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090016a.pdf

What is it? Belotero Balance is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. Hyaluronic acid is a protective, lubricating and binding gel that is produced naturally by the body.

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

When is it used? Belotero Balance 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? Belotero Balance will help smooth moderate to severe facial wrinkles and folds. In a clinical study, most (103 out of 118) patients needed two injections to achieve optimal wrinkle smoothing. The smoothing effect lasts up to six months and then slowly goes away.

Side effects include:

  • Initial reactions such as:
    • Localized swelling
    • Localized redness
    • Post-injection site pain
    • Localized bruising
    • Hardening of tissue at the injection site
    • Localized itching
  • Delayed reactions such as:
    • Lumps and bumps formation

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

  • severe allergies marked by a history of hypersensitivity to foods or medicines
  • severe allergies to gram-positive bacteria

Belotero Balance should not be implanted into:

  • bone, tendon, ligament, or muscle
  • blood vessels because it may block blood flow.

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

Other Resources: