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U.S. Department of Health and Human Services

Medical Devices

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Restylane® Injectable Gel - P040024/S051

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: Restylane® Injectable Gel
Applicant: Medicis Aesthetics Holdings, Inc
Address: 8125 N Hayden Road, Scottsdale, AZ 85258
Approval Date: October 11, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040024s051a.pdf

What is it? Restylane is a transparent hyaluronic acid gel that is injected into a patient’s lips to increase their size. Restylane® is also approved for injection into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds). Hyaluronic acid is a protective, lubricating and binding gel substance that is produced naturally by the body.

How does it work? Restylane® works by temporarily increasing the size of the lips or creating a smoother appearance to the face when used for wrinkles and folds. In the clinical study, patients needed one or two injections to get optimal lip fullness. The effects of the injection last about six months.

When is it used? Restylane® is injected by a doctor into the lips of patient’s with thin lips. The gel temporarily adds volume to the skin and can give the appearance of a fuller lip.

What will it accomplish? Restylane® will help increase the size of a patient’s lips and help smooth moderate to severe facial wrinkles and folds.

Side effects of Restylane include:

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

When should it not be used?

Restylane® should not be used in patients who have:

  • severe allergies marked by a history of anaphylaxis (hypersensitivity to the ingestion or injection of a drug or protein)
  • multiple severe allergies
  • severe allergies to gram-positive bacterial proteins

Restylane® should not be used for:

  • breast augmentation,
  • implantation into bone, tendon, ligament, or muscle, or
  • implantation into blood vessels, because it may obstruct blood flow.

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

Other Resources: