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FDA Approves Fourth Wrinkle Filler

Hylaform Approved for Moderate to Severe Facial Wrinkles

WebMD Health News

April 23, 2004 -- The FDA has approved another injectable wrinkle filler for those who want to hide the effects of aging.

Today the agency approved Hylaform (hylan-B gel) for the treatment of moderate to severe facial wrinkles and folds, according to Inamed Corp. Inamed is the worldwide distributor of Hylaform, which is manufactured by Genzyme Corp.

Hylaform is a clear, colorless hyaluronic acid -- a naturally occurring substance found in human skin and throughout the body. Hylaform comes from the combs of specially bred roosters.

The gel is the fourth injectable wrinkle treatment to gain approval from the agency. Restylane, a synthetic form of hyaluronic acid, was approved in December.

Botox (botulinum toxin) is approved for treating wrinkles between the eyebrows, and collagen injections are approved for filling other types of wrinkles and skin imperfections.

Hylaform Approved to Treat Wrinkles

Researchers say that unlike collagen injections, no pretreatment skin allergy tests are required with hyaluronic acid injections, such as Hylaform and Restylane.

Hyaluronic acid injections work by filling the space between collagen and elastin fibers within the skin, which replenishes the natural volume lost with aging. The body naturally absorbs the gel over time. Repeated injections of Hylaform may be needed to maintain results.

Common side effects of Hylaform include redness, bruising, and swelling but are generally considered mild.

Clinical trials of Hylaform did not include people allergic to birds. Because Hylaform is made from rooster combs, doctors are urged to find out whether patients have bird allergies before using Hylaform.

Researchers also caution that the safety and effectiveness of using hyaluronic acid products in combination with collagen products have not been evaluated in clinical studies.

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