Although many websites or providers claim carboxytherapy is safe and FDA approved, it has not been clinically tested or FDA approved for these purposes
New York, NY (Vocus) July 30, 2009
The Physicians Coalition for Injectable Safety today issued a consumer warning about carboxytherapy and mesotherapy injections. These products, touting everything from cellulite treatment to weight loss are not FDA approved, and do not have clinical data that demonstrates results or safety.
Carboxytherapy uses carbon dioxide gas injected under the skin to reduce the look of cellulite, treatment of dark under-eye circles, and stretch marks and is also touted for fat sculpting on the face and the body. "Although many websites or providers claim carboxytherapy is safe and FDA approved, it has not been clinically tested or FDA approved for these purposes," says Coalition leader Robert Weiss, MD of Baltimore, MD. "Carboxytherapy for use around the eyes is especially dangerous. It could potentially release gas bubbles into blood vessels causing blindness. In addition, the risks of putting carbon dioxide in your body are currently unknown."
Mesotherapy, also known as injection lipolysis, is a mixture of vitamins, drugs and enzymes that are compounded (mixed together) to make the injected substance. "There is no conclusive, authoritative information that exists, such as unbiased, peer-reviewed clinical studies that meets the standards of an accepted medical journal, measuring both the efficacy and safety of mesotherapy," says Coalition leader Mark Jewell, MD, Eugene, Oregon. "We don't know the safety or efficacy of these compounds and, until there exists credible evidence, consumers are advised not to have these injections."
The Coalition urges consumers to be very selective about cosmetic treatments, and the individuals who provide them. "Only accept treatment prescribed by a qualified physician and administered under that physician's supervision. Whether an injection or treatment is to treat aging conditions, to treat cellulite or a similar body contouring condition, whether it sounds reasonable or too good to be true, you should always be aware of false claims," says Coalition leader Jeffrey Kenkel, MD of Dallas, TX. "Verifying that the drug or device that is recommended for your injection is FDA approved is an important first step. It should be approved specifically for cosmetic use as prescribed or similarly to what is prescribed for you."
The Coalition offers consumers extensive, easy to use resources including a cosmetic injection planner with all the questions you must ask your provider at http://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. In addition Consumers are urged to ask and consider 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?
The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, The American Society for Dermatologic Surgery, the American Society of Plastic Surgeons, American Academy of Facial Plastic and Reconstructive Surgery, the American Society of Ophthalmic Plastic and Reconstructive Surgery, the International Society for Aesthetic Plastic Surgery, the International Federation of Facial Plastic and Reconstructive Surgery Societies and the Canadian Society for Aesthetic Plastic Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.
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