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"Consumers who have had Botox(R) injections for cosmetic indications or who are considering Botox(R) 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. Botox(R) has 6 FDA label approvals including cosmetic indications to treat facial expression lines caused by the contraction of facial muscles. Clinical applications of Botox(R) to treat serious neuromuscular disorders such as cervical dystonia and cerebral palsy are the source of data regarding the reported adverse events. The Botox(R) Cosmetic brand is specifically labeled and approved for cosmetic indications. Myobloc(R) is not approved for cosmetic indications.
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"The present concern about adverse events following Botox treatment is focused on cases where botulinum (Botox(R) or Myobloc(R)) 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 Botox(R) 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 the 1031 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 Botox(R) 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."
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 Botox(R) for cosmetic indications should discuss their concerns with a properly trained and qualified physician who regularly treats patients' cosmetic concerns with Botox(R). In addition, the Coalition offers consumers a Cosmetic Injectable Planner at www.injectablesafety.org that provides clarity and key steps to a safe experience with any cosmetic injectable treatment.
About Us
The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Faci
