Botox Cosmetic
On April 15, 2002, the Food and Drug Administration (FDA) approved the use of Botulinum Toxin Type A, Botox Cosmetic, for the temporary relief of moderate to severe frown lines between the brow. It is important to note, however, that the use of Botox Cosmetic for any purpose other than frown lines between the brow is still considered off-label usage and is not approved by the FDA.
Both Allergan, developers of Botox Cosmetic, and Mark Gorney, M.D., F.A.C.S., a plastic surgeon and medical director of The Doctors Company, emphasize that physicians administering Botox must understand the relevant neuro-muscular and orbital anatomy as well as any alterations to the anatomy resulting from prior surgical procedures.
While the drug has been used for years for off-label cosmetic purposes, "Botox Parties" are a new development that have increased public awareness and demand. The press’ "party" terminology is unfortunate, trivializing the procedure and making attention to informed consent all the more important.
High-profile patients
Many people who seek Botox Cosmetic treatments to improve their appearance are high-profile individuals whose business is to be in the public eye, such as entertainers and television personalities. If anything should go wrong with a Botox treatment for such a patient, even a temporary paralysis of three or four months could mean a very expensive malpractice lawsuit for the loss of their high-level incomes, lost contracts and opportunities as well as emotional distress.
The following risk management recommendations may assist physicians in avoiding liability and providing better patient care.
Practicing outside the clinical setting
Performing procedures outside of a clinical setting is a cause for concern on many levels, but the most important is the lack of medical equipment and trained personnel in case of an unforeseen response to the Botox. According to Allergan, anaphylaxis is a recognized complication.
Providing alcoholic beverages to patients
The use of alcohol voids the informed-consent process.
Group informed consents
Providing Botox injections is a medical procedure, and, in doing so, a physician should not deviate from usual and customary practice. This includes a medical history and physical and informed consent in a private setting. The patient must be free to ask questions and share medical background information they may not want to—and legally should not have to—share in a group setting.
The informed-consent process is especially important with Botox, because, contrary to press information, adverse reactions to Botox are not limited to nausea and headaches. Though rare, there have been far more serious reactions, including death. Some of these patients had pre-existing conditions, such as cardiovascular disease, which would only be disclosed by performing a proper medical history.
Additionally, many of the patients mentioned in the press are women of childbearing age. Are they aware of the potential risk of fetal malformation if they become pregnant after the administration of Botox? Without the informed-consent process, how would they know?
Please be aware that administration of Botox outside of the clinical setting, or in a setting where alcoholic beverages are being served, or without the use of an individual, private, informed-consent process, complete with medical history, is contrary to The Doctors Company’s underwriting guidelines and may affect your future insurability.
