Dysport(R) Cosmetic Injection - For Erasing Wrinkles - Receives U.S. FDA Approval

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 08 Jun 2009 - 8:00 PDT

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A new wrinkle-smoother will be arriving in doctors' offices in July: the U.S. FDA has approved the cosmetic injectable Dysport®. Dysport®, approved in the European Union, Brazil, Argentina and more than 26 countries worldwide is a form of botulinum type A, similar to the protein found in Botox® Cosmetic, approved for fighting wrinkles in the U.S. since 2004. Dysport® and Botox® are both cosmetic injections that temporarily relax the muscles in the face that create expressions, such as frown lines between the brows, that over time result in visible facial lines and deeper creases. "Although their action is similar, Dysport® and Botox® Cosmetic are two different drugs," said oculoplastic surgeon Dr. Brian Biesman, Coalition leader and Assistant Clinical Professor at Vanderbilt University Medical Center in Nashville, TN. "Both temporarily modify the action of facial muscles, smoothing out undesirable lines between the brows, across the forehead or crow's feet to restore a more youthful, less stressed appearance. But they are not interchangeable, they have distinct dosing differences."

"Cosmetic injections of any kind require examination, the informed consent process and prescription, including the proper dose, by a qualified board-certified plastic surgeon, facial plastic surgeon, oculoplastic surgeon or dermatologist, to achieve both a visually pleasing and a safe outcome. The doctor you choose should also either provide the injection or directly supervise the registered nurse (R.N) or physician's assistant (P.A.) who will inject you," said plastic surgeon and Coalition leader Mark Codner, MD, of Atlanta, GA. "In my practice, I inject all my patients personally. You have the right to request that your doctor perform the injection if you wish."

"Whether Dysport® or Botox® Cosmetic is right for you is a decision between you and your doctor; in every instance communication is key. If you have been injected with one or the other in the past, let your doctor know," recommended Coalition leader Mary Lynn Moran, MD, a San Francisco, CA, area facial plastic surgeon. "These are immensely safe treatments, more than 21 million people have been injected with genuine Dysport® or Botox® Cosmetic in the U.S. by qualified doctors in the past decade* and rarely have there been complications. The most serious complications reported from these injections are a temporary eyelid droop; its rare, data shows it occurs in less than 2% of patients, and well-trained doctors can usually avoid this outcome."

"Cosmetic injections are a category of cosmetic medicine really only a decade old," said Coalition leader Dr. Richard D'Amico, a plastic surgeon from Englewood. NJ. "There is a lot for consumers to learn, and unfortunately, with the valid information there is also hype and hearsay that includes physicians who are not trained in medical aesthetics, and who lack lack the training and credentials necessary to ensure safety and excellent results. The goal of the Coalition has been to provide consumers a complete, authoritative and unbiased resource for this information," said Dr. D'Amico. "No consumer should have an injection without visiting www.injectablesafety.org, first."

The Coalition, who this week launches a new, consumer friendly site with video, FAQs and more, offers consumers extensive, easy to use resources including a cosmetic injection planner with all the questions you must ask your provider at www.injectablesafety.org. In addition, an up-to-date listing of the status of investigational and approved cosmetic injection drugs and devices is available on the site, as well as pictures that will help consumers identify a genuine brand. Consumers are urged to ask these simple questions before considering any cosmetic injectable procedure:

- Doctor: Is the injectable recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility? Has the doctor examined the prospective patient before recommending treatment?

- Brand: Is the injectable recommended approved by the U.S. FDA,, and by equivalent agencies in the country of origin, for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval?

- Safety: Is the setting a proper medically-equipped office, with safety and sterilization procedures? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?

*Compiled from the 1997-2008 Cosmetic Surgery National Data Bank Statistics of multi-specialty data; surgery.org/press/statistics.php.

Source
The Physicians Coalition for Injectable Safety