Hylaform Plus

Hylaform Plus has been withdrawn from the U.S. market.

Generic name: hylan B gel
Approval date: October 13, 2004
Company: Inamed Corporation and Genzyme Corporation
Treatment for: Wrinkle Correction

Hylaform Plus has been withdrawn from the U.S. market.

The U.S. Food and Drug Administration (FDA) previously approved Hylaform Plus (Hylan-B gel), a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds.Hylaform Plus was developed and manufactured by Genzyme Corporation.

Hylaform Plus is a sterile, nonpyrogenic, viscoelastic, clear, colorless, transparent gel implant composed of cross-linked molecules of hyaluronan. Hyaluronan is a naturally occurring polysaccharide of the intercellular matrix in human tissues, including skin.

Hylaform Plus is injected into the dermal tissue to provide a space-occupying viscoelastic supplement for the intercellular matrix of the connective tissue. This viscosupplementation or augmentation of the dermal tissue can result in the correction of skin contour deformities caused by wrinkles or folds.

Hylaform Plus Side Effects

Based on clinical studies redness, bruising, swelling, pain, bumps, tenderness and itching may occur as a result of the injection with Hylaform gel. Most of these symptoms were mild and went away. As with all procedures that involve an injection through the skin, there is a risk of infection.

It is possible for the needle to be accidentally placed through a blood vessel during injection,which could result in a temporary change in color or in tissue death in the treated area leading toa scab and/or scar formation.

Any redness and/or visible swelling that lasts for more than a few days may indicate a reaction tothe material. Be sure to report any symptoms to your physician.