Restylane: Legal or Illegal?

New York, NY (March 6, 2003) There have been numerous reports in the media about "illegal" injection of Restylane, a crystal clear gel containing hyaluronic acid and used for soft tissue filling of lips, facial wrinkles and facial folds. Restylane has been used in Canada and Europe, but the filler has not yet been approved by the Food and Drug Administration (FDA) for cosmetic use in the United States.

While Restylane does not have FDA approval (though predictions are that it may be approved later this year), it is not a prohibited drug. In general, a qualified physician may obtain access to an unapproved drug by participating in a clinical study as an investigator. This requires obtaining permission from an Institutional Review Board (IRB), filings with the FDA, and special consent forms for patients. Some unapproved drugs can be used without IRB approval on an emergency basis; however, this exception is reserved for the treatment of life-threatening conditions.

As in all medical and surgical procedures, full informed consent by the patient based on accurate information regarding risks and benefits is essential. In the case of an approved clinical study, patients must be completely informed about a drug's investigational status and the physician's status, if any, as a consultant to the drug manufacturer. The American Society for Aesthetic Plastic Surgery (ASAPS) supports the rights of patients and their doctors to participate in approved clinical investigations. In the case of Restylane, there is significant clinical experience in other countries to suggest at least short-term safety for use as a cosmetic wrinkle treatment. However, additional documented studies are needed to fully assess Restylane's long-term benefits and risks.


The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.


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