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U.S. Department of Health and Human Services

Medical Devices

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Restylane-L Injectable Gel - P040024/S056

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-L Injectable Gel
PMA Applicant:
Medicis Aesthetics, Inc
Address:
7720 N. Dobson Rd, Scottsdale, AZ 85256
Approval Date:
August 30, 2012
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs/ pdf4/p040024s056a.pdf

What is it? Restylane-L is a transparent hyaluronic acid gel that is injected into a patient’s lips to increase their size. Restylane-L 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. Restylane-L contains 0.3% Lidocaine.

How does it work? Restylane-L 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-L is injected by a doctor into areas of facial tissue with moderate to severe wrinkles and folds or the lips of patients over the age of 21 with thin lips. The gel temporarily adds volume to the skin and can give the appearance of a fuller lip or a smoother surface.

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

Side-effects of Restylane-L include:

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

When should it not be used? Restylane-L 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 protein
  • previous hypersensitivity to local anesthetics of the amide type, such as lidocaine
  • bleeding disorders

Restylane-L 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: The Summary of Safety and Effectiveness Data and labeling are available online.

Other Resources: