This is a truly tragic example of the countless cases where consumers take unnecessary risks for what they believe will be treatments that improve appearance and in fact result in grave complications
New York, NY (Vocus) February 18, 2009
Life-threatening kidney-failure is a strong and convincing reminder for consumers that unapproved injections and unqualified injectors are a true threat to beauty and to health, cautions Physicians Coalition for Injectable Safety. Recent headlines from Tampa, Florida focus on an unlicensed, non-medical provider who allegedly injected two women with a homemade combination of industrial silicone oil and saline to augment or enhance the shape of their buttocks, with both women now hospitalized with critical, potentially irreversible illness. "This is a truly tragic example of the countless cases where consumers take unnecessary risks for what they believe will be treatments that improve appearance and in fact result in grave complications," said Renato Saltz, MD, of Salt Lake City, a leader of the Physicians Coalition for Injectable Safety.
More tragic is that this is not the first incidence of severe or life-threatening complications after injections by unqualified injectors or with illicit and illegal substances. In 2006, the New England Journal of Medicine reported on respiratory failure and subsequent death in a patient after injection of illegal and illicit silicone.
The Coalition, charged with educating consumers on safe choices for legal, FDA approved cosmetic injections provided by qualified physicians in appropriate medical settings, has seen a steady growth of conversations and coverage on-line of people who are unaware of inevitably dangerous practices. "There are blogs filled with conversations among women and men who knowingly seek what are unresearched, unaccepted and dangerous injection treatments from enhancing the buttocks, to melting fat," noted Coalition leader Dr. Julius Few, of Chicago, Illinois. "The reality is that any treatment that is not administered or prescribed by a physician and any treatment that is not FDA approved or part of a known and appropriately conducted clinical trial is simply a game of Russian Roulette. You are taking chances with your life." Dr. Few has seen complications from botched procedures by unqualified or unlicensed practitioners on the rise his own community, as have 75% of Coalition members according to an October 2008 study by the Coalition (http://www.injectablesafety.org/downloads/InjectableSafetySurveyResults1029.pdf).
"Branded, FDA approved injectables have an outstanding record of consistent cosmetic results and safety when administered by appropriately trained physicians," said Dr. Saltz. "The complication rate for dermal fillers is less than 1 in 11,000* cases when known brands are administered by trained plastic surgeons, facial plastic surgeons, ophthalmic plastic surgeons and dermatologists. This great record of success and safety absolutely does not translate to the counterfeit, illegal and non-medical practices that lure consumers with false promise and bargains." *An independent study by research group Industry Insights of FDA compiled data in November 2008, specifically states the rate and type of adverse events reported to the FDA, and is available at http://www.injectablesafety.org.
"On-line information can be helpful to the consumer education process regarding cosmetic injections when these sources are from credible medical organizations, such as the Coalition, or plastic surgery and dermatologic specialty societies or from legitimate manufacturers and pharmaceutical company's web sites, even from the U.S. FDA or the regulatory agencies of one's home country," said Dr. Few. "No consumer should accept the credibility of information or accept treatment that is offered through blogs and chat rooms, that is provided by a non-physician in a non-medical setting, or that lacks proper medical procedure including the informed consent process. There simply is no greater warning to safety."
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 physician's 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 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: http://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 http://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 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 http://www.injectablesafety.org.