Coalition Responds to Consumer Concerns on Lipodissolve
December 12, 2007 - The Physicians Coalition for Injectable Safety today issued an advisory for consumers with questions or concerns about fat dissolving, fat melting, injection lipolysis or other injectable treatments touted to reduce localized body fat. The proliferation of advertising of such treatments and the abrupt closing of Fig lipodissolve centers nationwide has evoked many questions from both patients considering treatment, and those who have already been injected with the unproven medical treatments touted to reduce localized fat. To date, injection lipolysis, lipodissolve or any fat-melting injection has not gone through FDA sanctioned clinical trials or the research necessary to document the results claimed or clearly identify the potential underlying complications.
"The closing of Fig centers has left many consumers without results, with complications and with a great investment in treatments that have not been proven effective or safe. Consumers with questions, or who have endured complications should seek out the advice of a board-certified plastic surgeon specializing in accepted aesthetic procedures such as liposuction," says coalition leader Mark L. Jewell, MD, and Past President of the ASAPS. "Anyone experiencing serious complications that affect personal health should immediately seek out the advice of a qualified medical doctor."
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. "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," said coalition leader Roger A. Dailey, MD, FACS, of Portland, Oregon and professor at Oregon Health & Sciences University. "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."
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?
To learn specifically the FDA approved brands of cosmetic injectables and their benefits, and to see video of live, appropriately administered injectables, visit http://www.injectablesafety.org.
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.
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.
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.
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.