Coalition warns patients there are no safe substitutes for authentic, FDA approved injectables
NEW YORK, Oct. 8 /PRNewswire-USNewswire/ -- Cheaper, unbranded, unapproved and counterfeit cosmetic injectables are a threat to your looks and your health warns the Physicians Coalition for Injectable Safety. "The growing acceptance of cosmetic injections for their good outcomes and convenience in treatment comes with consumer cautions," says Coalition leader, plastic surgeon Jeffrey Kenkel, MD of Dallas, Texas. "Disreputable injectors and counterfeit, imported or unapproved injectables present the greatest risk to a patient's appearance, and ultimately one's health." In the period between 2004 and July 2008 the U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) entered in 210 investigations that led to 68 arrests and 29 convictions of health care professionals who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox(R) Cosmetic into nearly 1,000 unknowing patients. Specifically what is injected and by whom are important details no consumer should take casually.
"Cosmetic injections can be highly gratifying procedures. The Coalition, which represents doctors dedicated to treating cosmetic and aging concerns of the face, encourages consumers who seek a positive experience to ask questions of one's injector regarding their experience and about the product being injected. It might be best to shy away if there are any incomplete or unclear answers," says Coalition leader, oculoplastic surgeon Roger Dailey, MD, FACS of Portland, Oregon. "Anyone, including consumers, who suspect the criminal act of soliciting non-approved, off-shore, counterfeit or illicit injectables in the U.S. is urged to anonymously report the suspected illegal activity to the FDA." Information on reporting a suspected crime to the FDA can be found at http://www.fda.gov/consumer/updates/oci072307.html.
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 very cautious
steps for both safe, and positive outcomes:
-- Doctor: Ask specifically about your doctor or injector's
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 and who examines
you, prescribes and performs cosmetic injections 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 the brand name of the injectable recommended for
you, the approval status of regulatory agencies in the country where you
will be treated (the U.S. 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 U.S. 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
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. All consumers, regardless of where you live, should be aware that counterfeit product may be used in your country. For assistance with this issue please contact the International Society for Aesthetic Plastic Surgeons at http://www.isaps.org, the International Federation of Facial Plastic Surgery Societies at http://www.aafprs.org/links/whatis.html, or the Canadian Society for Aesthetic Plastic Surgery at http://www.csaps.ca.
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 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.
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 ocular surgery (currently two years), and perform aesthetic, plastic, and reconstructive surgery of the face, orbits, eyelids, and lacrimal system.
Founded in 1970 at the United Nations in New York, ISAPS represents 1650 members in 85 countries and is the leading authority in international aesthetic plastic surgery. Members must pass stringent admission criteria and are all board certified or the equivalent in their home country. More information can be found at http://www.isaps.org.
The Canadian Society for Aesthetic Plastic Surgery is the only professional organization in Canada dedicated to improved cosmetic surgery outcomes through education, research, and the maintenance of high surgical standards of clinical practice. Our membership is comprised of fully trained and certified specialists in plastic surgery who have demonstrated their commitment to excellence in the cosmetic and aesthetic areas of our specialty.
The International Federation of Facial Plastic Surgery Societies (IFFPSS) is a group of societies of facial plastic surgeons from various countries around the world. This Federation was formed in 1997. The goals of the IFFPSS are to promote and support the growth of Facial Plastic Surgery throughout the world. Education, in every form, is the primary focus of this support.
|SOURCE Physicians Coalition for Injectable Safety|
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