Coalition Says Synthetic Fillers and Large Volume Injections Dangerous
New York, NY (Vocus) December 15, 2009 -- The popularity and hype surrounding buttock augmentation and other large-volume body enhancing injections on blog sites like RealSelf.com and outside U.S. borders is an alarming and potentially deadly trend, cautions the Physicians Coalition for Injectable Safety. Permanent fillers such as polymethylmethacrylate (PMMA), silicone, and polyacrylimide used in augmenting buttocks, hips, and even breasts can not only result in disfigurement but have resulted in death and serious injuries both in the U.S. and abroad. Synthetic fillers are used without extensive studies to determine safety and long-term outcomes.
The recent death of a woman in Argentina following buttock augmentation is not a result of plastic surgery," says Brazilian plastic surgeon Joao Carlos Sampaio Goes, MD, PhD, and past president of the International Society for Aesthetic Plastic Surgery. It is the result of a dangerous practice with fillers that are not intended to be used in this way." Buttock augmentation is a hot topic in the media and a popular procedure of surgical tourism," often performed in countries where standards are less stringent.
This is not an incident or practice isolated to the U.S," says Baltimore dermatologist Robert Weiss, MD, Immediate Past- President of the American Society for Dermatologic Surgery. Recent headlines of death in the U.S. include cases in Tampa, Florida where an unlicensed, non--medical provider allegedly injected two women with a homemade combination of industrial silicone oil and saline to augment or enhance the shape of their buttocks, and a woman in the Bronx who died after illegal silicone injections resulted in the substance migrating to (traveling) her lungs and producing respiratory failure."
The Coalition reminds consumers that no pharmaceutical filler or injected device is presently U.S. FDA-approved for large volume injection to the buttocks. Ones own fat (autologous fat) and U.S. FDA approved gluteal implants are the only researched and accepted procedures for augmenting the buttocks. The only PMMA based filler approved for use in the U.S. is Artefill, strictly for limited areas of the face to treat deep folds, and used off-label by some plastic surgeons in reconstruction of the nipple following mastectomy. No silicone or polyacrylimide is presently approved as a cosmetic injection in the U.S. Risks from these injections include permanent granulomas, (lumps within the skin), infection and skin ulceration that can lead to necrosis, life-threatening kidney-failure, and potentially fatal pulmonary emoblism (blood clot).
Any cosmetic injection or procedure can be immensely rewarding when performed with proven techniques, by a qualified, board-certified physician, with approved drugs, devices, or ones own fat, and in a safe and accredited setting," says Salt Lake plastic surgeon Renato Saltz, MD, President of the American Society for Aesthetic Plastic Surgery. Ethical, qualified cosmetic physicians today are compelled to take the responsibility to educate the public about unregulated, unproven, unaccepted practices that may result in unattractive permanent complications and potentially serious threats to life. Beauty and self-image can be enhanced and improved in very fulfilling and safe ways, but not when prompted by hype or performed by non-physicians or untrained physicians. In these cases the risks far out weigh any potential for improving ones appearance."
The Coalition, charged with educating consumers on safe choices in cosmetic injections and eradicating the use of counterfeit and illegally imported cosmetic injectables, suggests all consumers follow these steps to ensure safe and effective treatment:
• Doctor: Ask your doctor or injector for qualifications. Choose a doctor who specializes in treating all cosmetic concerns of the face, such as a board certified plastic surgeon, facial plastic surgeon, oculoplastic surgeon or dermatologist. Examinations and procedures should take place in a licensed and properly equipped medical facility. Establish a positive and on-going relationship with your doctor and follow-up as directed. A nurse or physicians assistant may perform your injection if you elect, but a licensed physician must prescribe the treatment.
• Brand: Ask specifically for the brand name of the injectable recommended for you, the approval status of regulatory agencies in the country where you will be treated (the FDA in the United States) and about any potential outcomes and the likelihood of adverse events. If your doctor does not offer, ask specifically to see the packaging and identifying marks that can verify authenticity, including identifying holograms and logos for the brand, the serial and lot number (which as a matter of proper procedure must be recorded in your medical chart). For reference, images of all US FDA approved brand logos and packaging are available at: www.injectablesafety.org/html/ataglance.php.
• Safety: If you suspect your injector is not properly trained, is not following proper procedure or is injecting you with a non-branded, non-approved or unsafe substance, do not accept treatment. Follow-up by anonymously reporting suspected illegal activity to your local FDA field office that can be found at http://www.fda.gov/consumer/updates/oci072307.html.
To learn more about the benefits of cosmetic injections, the uses for approved cosmetic injectables, to plan for your treatment, see video of live, appropriately administered injectables and more, visit www.injectablesafety.org and http://www.realself.com/injectable-safety-campaign.
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, the American Society of Ophthalmic Plastic and Reconstructive Surgery, the American Society of Plastic Surgeons, the American Society for Dermatologic Surgery, the American Academy of Dermatology, the International Society for Aesthetic Plastic Surgery, the International Society for Facial Plastic and Reconstructive Surgery 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 www.injectablesafety.org.
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