Clarity for Consumers On Botox Complication and Death Reports
New York, NY - February 22, 2008 - The Physicians Coalition for Injectable Safety has issued a statement offering consumers clarity on the safety of BotoxÂ® injections after reports of serious complications following treatment with Botox for clinical indications.
"Consumers who have had BotoxÂ® injections for cosmetic indications or who are considering BotoxÂ® for cosmetic indications should not be alarmed by recent reports of adverse events, but must put this report into perspective," said Coalition Leader Mark L. Jewell, MD, past president of the American Society for Aesthetic Plastic Surgery. BotoxÂ® has 6 FDA label approvals including cosmetic indications to treat facial expression lines caused by the contraction of facial muscles. Clinical applications of BotoxÂ® to treat serious neuromuscular disorders such as cervical dystonia and cerebral palsy are the source of data regarding the reported adverse events. The BotoxÂ® Cosmetic brand is specifically labeled and approved for cosmetic indications. MyoblocÂ® is not approved for cosmetic indications.
"The present concern about adverse events following Botox treatment is focused on cases where botulinum (BotoxÂ® or MyoblocÂ®) was injected to treat very serious neuromuscular disorders and serious medical illness," noted Coalition leader Ira D. Papel, MD, past president of the American Academy of Facial Plastic and Reconstructive Surgery. It is estimated that since 2002, 17 million injections of BotoxÂ® have been safely administered 1 for cosmetic purposes. A total of only 1031 adverse events have been reported with Botox or Myobloc, and the vast majority are clinical uses in patients with very serious illness. Of the1031 reported events, 995 were considered by the FDA to be non-serious; serious complications represent one in 16,500 patients. "By comparison, the adverse event rate for aspirin is estimated to be over 300 times higher,2 " said Dr. Papel.
"The dosing of BotoxÂ® to treat the medical disorders is often ten-fold the number of intramuscular units (i.u.'s) injected to treat the cosmetic patient," said Coalition leader Roger Dailey, MD, past president of the American Society for Ophthalmic Plastic and Reconstructive Surgery. "In perspective, a typical dose to treat the glabella, or furrows between the brows consists of 20 to 35 units (i.u. or intramuscular units), whereas a patient treated for a neuromuscular disorder may receive 200 or more units."
Compilation of annual statistics reported by the American Society for Aesthetic Plastic Surgery 2002 to 2006.
1 Quan, Dan, MS; LoVecchio, Frank, DO; Clark, Bryan, DO; Gallagher, John, MD. Prehospital and
2 Disaster Medicine ; volume 19, number 4; http://pdm.medicine.wisc.edu/19-4%20PDFs/LoVecchio.pdf
The Coalition's prevailing safety message for consumers considering or accepting treatment with cosmetic injectables is one of full disclosure, and emphasizes "Doctor. Brand. Safety":
- Doctor: Is this treatment being 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 its authenticity and approval?
- Safety: Have the proper procedures been followed? Has the physician has evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?
Consumers who have questions about the safety of BotoxÂ® for cosmetic indications should discuss their concerns with a properly trained and qualified physician who regularly treats patients' cosmetic concerns with BotoxÂ®. In addition, the Coalition offers consumers a = anchor('/consumers/cosmetic_injectable_planner','Cosmetic Injectable Planner') ?> that provides clarity and key steps to a safe experience with any cosmetic injectable treatment.
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.