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U.S. Department of Health and Human Services

Medical Devices

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Hylaform - P030032

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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.


Product Name: Hylaform
Applicant: Genzyme Corporation
Address: 500 Kendall St., Cambridge, MA 02142
Approval Date: April 22, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030032a.pdf

What is it? Hylaform gel is sterile and colorless skin (dermal) filler made of chemically modified hylauronic acid derived from a bird (avian) source. Hylauronic acid is a naturally occurring substance found in cell and tissue fluids. It is chemically, physically, and biologically similar in the tissues of all species. Hylaform gel is made from purified, natural hylauronic acid that is gradually absorbed by the body.

How does it work? Hylaform works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face. The effect lasts for about 12 weeks. After the initial treatment, “touch-up” treatments may be needed to achieve optimal skin smoothing. Repeat treatments may be needed to maintain the smoothing effect.

When is it used? Hylaform 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 face.

What will it accomplish? Hylaform will help smooth moderate to severe facial wrinkles and folds for about 12 weeks. Some patients in a clinical study needed more than one injection to achieve a satisfactory result. Side effects of Hylaform include:

  • bruising,
  • redness,
  • swelling,
  • pain,
  • tenderness, and
  • raised bumps of skin (nodules).

When should it not be used? Hylaform should not be:

  • used in patients who have a history of known hypersensitivity to avian proteins,
  • used for breast augmentation,
  • used for implantation into bone, tendon, ligament, or muscle, or
  • injected into blood vessels because Hylaform may clog the vessels, restricting blood flow and killing tissue (embolization or infarction).

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030032