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Medical Devices

Restylane Silk Injectable Gel - P040024/S072

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 Silk Injectable Gel
PMA Applicant: Valeant Pharmaceuticals North America LLC/Medicis
Address: 400 Somerset Corporate Blvd. Bridgewater, NJ 08807

Approval Date: June 13, 2014

Approval Letter:

What is it? Restylane Silk is a transparent hyaluronic acid gel that is injected into patients’ lips and wrinkles around the mouth. Hyaluronic acid is a protective and lubricating gel that is produced naturally by the body. Restylane Silk is a new approved material that may increase the volume of patients’ lips and may smooth wrinkles around the mouth.

How does it work? A doctor injects Restylane Silk in a patient’s lips and wrinkles around the mouth one or two times as needed over a period of two weeks. The product works by temporarily adding volume to the lips and smoothing wrinkles around the mouth. The effect lasts for about 6 months.

When is it used? Restylane Silk is used in patients over the age of 21 with thin or very thin lips. The gel temporarily adds volume to the skin which may result in larger lips and may smooth wrinkles around the mouth.

What will it accomplish? Restylane Silk may help increase the volume of patients’ lips and may smooth wrinkles around the mouth. In the clinical study, patients needed one or two injections to achieve the best lip volume and wrinkle appearance. The effect lasted about six months. The side effects of Restylane Silk include:

  • bruising
  • redness
  • swelling
  • pain
  • tenderness
  • itching

When should it not be used? Restylane Silk should not be used in patients who have:

  • severe allergies with a history of acute allergic reactions (anaphylaxis)
  • multiple severe allergies
  • severe allergies to gram-positive bacteria such as streptococcus
  • bleeding disorders
  • hypersensitivity to local anesthetics such as lidocaine

Restylane Silk should not be used for:

  • implanting into bone, tendon, ligament, or muscle.
  • implanting into blood vessels because it may obstruct blood flow and cause tissue death or impair vision.

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

Page Last Updated: 01/11/2016
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