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Important Patient Instruction

    Restylane manufactured by Medicis Aethetics is a cosmetic dermal filler employed for facial augmentation that is composed of non-animal based hyaluronic acid. The product Restylane is commercially produced from bacterial - derived fermentative sources. Restylane was approved for human use in the United States by the Food and drug Administration in December 2003 following its introduction in 1996 by dermatologists and plastic surgeions. Over 1 million units of Restylane have been utilized by physicians in 60 countries world-wide.

    Hyaluronic acid, a natural mucopolysaccharide present inthe human body, was first commercially employed in 1942 as a substitute for egg whites in bakery products and subsequently found to be effective in the medical sphere for eye surgery to protect the retina. When injected into the skin, Restylane binds with normal dermal collagen and elastin into a supportive matrix that provides fullness to facial folds and wrinkles that appear with aging. However the latter provided only temporary 3 plus month corrections, and was associated with occasional skin hyper-sensitivity reactions. Subsequent studies appearing in June 2003 issue of Dermatologic Surgery comparing the efficacy and tolerability of Restylane to Zyplast for correcting nasolbial fols documented that the hyaluronic acid based product (Restylane) provided a more durable aesthetic improvement than bovine collagen.

    Reports from various studies indicare that Restylane last upwards of 6 plus months for correction of prominent nasolabial folds, frown lines, and ddep facial wrinkles such as marionette perioral facial lines. The durable correction from Restylane last twice as long as for benefits derived from bovine-collagen. Becasue Restylane is employed for deep wrinkles, it is sometimes necessary to use Zyderm II (collagen) concurrently to correct fine facial or lip lines.

    The incidence of adversehypersensitivity to Restylane is of the order of 1/5000. It is not unusual for some patients to experience redness experience redness andminor discomfort at the site of injection (not hypersensitivity) but these complaints should abate within a day or two.

    Prior to patients receiving the facial injections of Restylane it is important that they avoid taking aspirin, non-steroidal anti-inflammatory agents and vitamin E for several days. The latter agents may increase the risk of bleeding into the skin. There is minimal pain from Restylane injections but patients who are significantly pain-sensitive may be pre-treated with topical application of 5% lidocaine cream to the sites 20 minutes before injection by the physician.