The FDA has issued warning letters to eight surgical centers in California and a marketing firm behind the 1-800-GET-THIN number for misleading advertising of the Lap-Band, an implanted device intended to promote weight loss in severely obese individuals.
According to the FDA, these groups posted billboards and mailed advertising inserts about Lap-Band that failed to provide “required risk information, including warnings, precautions, possible side effects and contraindications.” And in some cases where warnings were included, the FDA says the font size may be too small to be read.
“The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”
If these ads are not fixed in a timely manner, the FDA says further action, including product seizure or civil money penalties, could be merited.
“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”