Physician Reminder: Importation is Illegal
Coalition warns physicians against importation and encourages reporting of suspected illegal solicitation or use of BotoxÂ®, RestylaneÂ®, RadiesseÂ® and others
New York, NY, October 8, 2008 - Offer patients imported, unbranded, non-approved or otherwise illegal cosmetic injectables and you risk criminal prosecution and the potential loss of your medical license, warns the Physicians Coalition for Injectable Safety. "As cosmetic injections continue to grow in popularity worldwide and the variety of commercially available cosmetic injectables grows, physicians are reminded by the Coalition to purchase and inject only genuinely branded, FDA approved pharmaceuticals and devices in the country of origin," says Coalition legal counsel Robert Aicher. "If a physician knowingly or naively purchases an unapproved, counterfeit or off-shore product and offers this to a patient, it is a criminal offense." 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 BotoxÂ® Cosmetic into nearly 1,000 unknowing patients. "The fake-Botox cases represent just one example of investigation and subsequent prosecution," said Mr. Aicher. "Although dermal fillers are medical devices and not drugs, they too are subject to the same regulation." Anyone who suspects the criminal act of soliciting non-approved, off-shore, counterfeit or illicit injectables in the U.S. is urged to anonymously report the suspected crime 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 physicians follow very cautious steps when purchasing cosmetic injectables:
- Do not respond to on-line pharmacy or fax solicitations for cheaper alternative injectables, rather report these solicitations to your local FDA field office, which can be done with full anonymity.
- Do report any complications from suspected counterfeit injectables to your local FDA office along with the name and any appropriate information about the suspected injector, which can all be done with full anonymity.
- Do not use any non-FDA approved cosmetic injectable unless it is within the protocols of a formal investigational trial, and your patients are fully informed and elect to participate in such trial. In addition, uses for cosmetic injectables that push the limits of "off-label" indications must also be performed within the protocols of a clinical research.
- Do inspect any cosmetic injectable packaging for identifying marks, including the serial and lot number. For reference, images of all U.S. FDA approved brand logos and packaging are available at. http://www.injectablesafety.org/html/ataglance.php
A white paper outlining the penalties for physicians who purchase or administer illegal cosmetic injectables and other resources for purchasing injectables is available http://www.injectablesafety.org/physiciansonly/purchasing.php. Information on reporting a suspected crime to the FDA can be found at http://www.fda.gov/consumer/updates/oci072307.html. All physicians, regardless of where you practice, should be aware that counterfeit product may be solicited in your country. For assistance with this issue please contact the International Society for Aesthetic Plastic Surgeons at http://www.isaps.org, the Internation 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.