The FDA has warned 8 California surgical centers and the marketing firm 1-800-GET-THIN about what the agency says is misleading advertising of the Lap-Band gastric banding device.
The ads - splashed on billboards, bus placards, newspaper advertisements and online - tout all of the rewards of the Lap-Band, but none of the risks, says the FDA. They feature slender, smiling men and women claiming they lost massive amounts of weight and gained control of their lives after Lap-Band surgery. They include come-ons like "Ready to be the next weight-loss success story?", "Let your new life begin!" and "I lost 90 pounds with the Lap-Band!"
What's missing, says the FDA, is relevant risk information regarding the use of the Lap-Band, patient age and other qualifying requirements for the Lap-Band procedure, and notification of the need for ongoing modification of eating habits, as provided in the approved Lap-Band labeling. According to federal law, product advertising for certain medical devices, such as the Lap-Band, must contain relevant warnings and information about precautions, side effects, and contraindications.
"FDA's concern is that these ads glamorize the Lap-Band without communicating any of the risks," says Steven Silverman, director of the Office of Compliance in FDA's Center for Devices and Radiological Health. "Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure."
The FDA sent warning letters to Valencia Ambulatory Surgery Center in Valencia, Calif.; Bakersfield Surgery Institute, Palmdale Ambulatory Surgery Center, Valley Surgical Center, Top Surgeons, LLC, Cosmopolitan Plastic & Reconstructive Surgery and Beverly Hills Surgery Center in Beverly Hills, Calif.; and San Diego Ambulatory Surgery Center in San Diego, Calif.
FDA's warning letters direct the California marketing firm and the surgical centers to pull their misleading ads and to notify FDA within 15 working days of taking this corrective action.
Dan O'Connor
