The American Society of Plastic Surgeons (ASPS) addressed concerns
regarding the use of botulinum toxin products and adverse events
following a recent petition from a consumer group.
On January 23, Public Citizen requested the U.S. Food and Drug Administration
(FDA) implement labeling changes and a written communication to
physicians.
More than one million people have been treated with BOTOX Cosmetic.
Complications and adverse events from BOTOX Cosmetic treatments
are rare.
"As patient advocates, plastic surgeons are primarily concerned
about the safety of our patients," said Richard A. D'Amico,
MD, ASPS president. "We have a keen interest and expertise
in informing patients about intended use of the product and risks
and benefits."
ASPS believes that the safety issues identified in the petition
are currently addressed in the manufacturer labeling with detailed
information and guidance, including approved indications, contraindications,
warnings, drug interactions, precautions, and reported adverse event
information.
The ASPS works closely with the FDA on a range of issues and strongly
supports existing labeling requirements agreed to between the manufacturers
and the FDA.
Almost all drugs and devices have adverse events and complications
associated with them. It is important for physicians to have a proper
medical history of patients prior to them receiving any treatment.
Patients should be fully informed and educated about risks and benefits.
ASPS will continue to work closely with the FDA and manufacturers
on an ongoing basis regarding physician and patient education.
For referrals to ASPS Member Surgeons certified by the American
Board of Plastic Surgery, visit http://www.plasticsurgery.org
where you can also learn more about cosmetic and reconstructive
plastic surgery.
The American Society of Plastic Surgeons is the
largest organization of board-certified plastic surgeons in the
world. With more than 6,000 members, the Society is recognized as
a leading authority and information source on cosmetic and reconstructive
plastic surgery. ASPS comprises 90 percent of all board-certified
plastic surgeons in the United States. Founded in 1931, the Society
represents physicians certified by The American Board of Plastic
Surgery or The Royal College of Physicians and Surgeons of Canada.
American
Society of Plastic Surgeons
