RESTYLANE -- NEW, NATURAL PRODUCT SMOOTHS FACIAL WRINKLES. Pioneer Study of More Than 2,000 People by Drs. Bosniak and Zilkha Used For Pending FDA Approval.

Restylane -- a new and safer filler for facial wrinkles -- could soon be on the U.S. market. Already widely used throughout Europe, South America and Canada, Restylane smoothes out facial wrinkles and folds almost immediately. In addition, it compliments the use of Botox. Using this natural substance in the areas of the face with wrinkles creates greater volume, giving the patient a healthier and more vital appearance.

(PRWEB) August 21, 2003 -- Restylane -- a new and safer filler for facial wrinkles -- could soon be on the U.S. market. Already widely used throughout Europe, South America and Canada, Restylane smoothes out facial wrinkles and folds almost immediately. In addition, it compliments the use of Botox. Using this natural substance in the areas of the face with wrinkles creates greater volume, giving the patient a healthier and more vital appearance.

Between 1996 and 2001, Drs. Stephen Bosniak and Marian Cantisano-Zilkha studied 2,241 Brazilian patients that were treated with Restylane and found virtually no allergic reactions. Because we worked with all ethnic groups and skin types in Rio de Janeiro, rather than just people from a single ethnicity or skin type, our results can be seen in a real-world context," explained Dr. Bosniak.

Ours was truly a pioneering study and puts us at the forefront of using Restylane," added Dr. Zilkha. We better than anyone understand how to use this natural substance to help our patients look and therefore feel better."

The results of their work was published in the July issue of the medical journal Operative Techniques in Oculoplastic, Orbital and Reconstructive Surgery, which is read by thousands of ophthalmologists and plastic surgeons worldwide.

Unlike other fillers, Restylane is a compound (hyaluronic acid) found in our own bodies and is chemically related to sugar. Because Restylane is not made from animals, patients do not need to undergo a skin test for allergic reactions and so can have the injections immediately, rather than needing to wait for as much as two months for the results of a skin test.

Furthermore, because Restylane is not made from animals (as the protein collagen is), patients do not run any risk of contracting a disease from an animal or of having an allergic reaction to beef, chicken or eggs.

Drs. Bosniak and Zilkha developed their interest in Restylane as a result of their using it in eye surgery. Both doctors were trained as ophthalmic surgeons specializing in cosmetic work. Because of their focus on the human eye, they first became aware of the anti-wrinkle possibilities of Restylane.

Restylane is the safest filler for facial wrinkles we have ever encountered," said Dr. Bosniak. Plus, the benefits of Restylane last a long time, up to a full year for one injection."

According to QMED, the Swedish company that discovered Restylane, the substance already is in clinical trials in the U.S. The company bolstered their case with FDA by providing the agency with the results of the studies in Brazil by Drs. Bosniak and Zilkha. QMED hopes that FDA will approve Restylane as soon as this summer.

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