Consumer Safety Alert On Fat Dissolving Injections
"Injections to unwanted fat, using compounded pharmaceuticals, or herbal agents, claim a medical result -- the degradation (breakdown) of adipose (body fat) and it's excretion from the body," said Julius Few, MD, associate professor of plastic surgery at Northwestern University Feinberg School of Medicine, in Chicago and a member of the Coalition. "To date, the substances in these injections have not gone through FDA sanctioned clinical trials or the research necessary to document the medical results claimed or clearly identify the potential underlying complications."
The Coalition advises consumers of the importance of FDA approval for any pharmaceutical injected into the body. An injected substance that is not FDA approved should only be used as part of a formal clinical trial. "Clinical trials cannot be marketed, they can only be offered to patients who are already seeking some form of medical intervention for a condition, in this case, the reduction of localized fat," said coalition leader Roger A. Dailey, MD, FACS, of Portland, Oregon and professor at Oregon Health & Sciences University. "In addition, anyone who agrees to participate in a clinical trial is essentially agreeing to be a test subject."
"There is presently not valid research on fat-melting injections that demonstrate reproducible, safe outcomes. Consumers should not ignore the proliferation of blogs and media that are reporting the ineffectiveness and the complications experienced by fat-melting injections," added Dr. Dailey. "There is much more unknown and unproven about these injections than there is proven. This is not a beauty treatment. This is a medical treatment that involves hundreds of injections into the body of a compounded mixture of drugs. This mixture is not FDA approved nor has it been formally tested for predictable results or safety. That alone should steer consumers away from the marketing hype."
"There are many safe, and very effective cosmetic injectable treatments available to consumers with aging concerns, but fat melting or dissolving injections are presently not among them," added Dr. Few. "At present liposuction is the only approved, safe and proven method of reducing localized fat."
The Coalition offers consumers these very simple questions to ask before considering any cosmetic injectable procedure:
-- Doctor: Is the procedure recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility?
-- Brand: Is the injectable recommended approved by the U.S. FDA for cosmetic indications and is it appropriately labeled and packaged to reflect it authenticity and approval?
-- Safety: Has the proper process been followed? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?
About Us
The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, and the American Society of Ophthalmic Plastic and Reconstructive 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.
About ASAPS
The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS), founded in 1967, is the leading professional organization of plastic surgeons certified by the American Board of Plastic Surgery who specialize in cosmetic plastic surgery. With 2,100 members in the U.S., Canada, and many other countries, ASAPS is at the forefront of innovation in aesthetic plastic surgery around the world.
About AAFPRS
The American Academy of Facial Plastic and Reconstructive Surgery is the world's largest specialty association that represents over 2,700 facial plastic and reconstructive surgeons throughout the world. The AAFPRS is a National Medical Specialty Society of the American Medical Association (AMA), and holds an official seat in both the AMA House of Delegates and the American College of Surgeons board of governors. AAFPRS members are board certified surgeons whose focus is surgery of the face, head, and neck.
About ASOPRS
The American Society of Ophthalmic Plastic and Reconstructive Surgery represent surgeons qualified in plastic surgery of the eyelids and surrounding facial structures. Fellows of the Society are board certified in ophthalmology, have completed fellowships in oculofacial plastic surgery (currently two years), and perform aesthetic, plastic, and reconstructive surgery of the face, orbits, eyelids, and lacrimal system.
American Society for Aesthetic Plastic Surgery
http://www.surgery.org
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