In an unusual move, the Food and Drug Administration has warned a marketing company and eight surgery centers in Southern California that their billboards and other advertisements touting weight-loss surgery are misleading because they don’t adequately describe the risks from the procedure.
The agency’s letters ask the surgery centers and the marketing firm 1-800-GET-THIN to pull the allegedly misleading advertising.
In a letter to 1-800-GET-THIN, the agency cites a billboard whose copy reads:
“LOSE WEIGHT WITH THE LAP-BAND! SAFE 1 HOUR, FDA APPROVED; 1-800-GET-THIN; 1-800-953-5000; PPO INSURANCE; FREE INSURANCE VERIFICATION”
The billboard and other ads don’t tell prospective patients enough about risks and other important factors, such as the age range and body mass index required to qualify for the Lap-Band, according to the FDA.
Even some marketing materials that include a few more details, such as suggesting a physician consultation, don’t go far enough in the agency’s view.
The adjustable Lap-Band, made by Allergan, can help people lose weight by reducing the amount of food their stomach can hold. Side effects include nausea and vomiting, difficulty swallowing and severe heartburn. Repeat surgery is sometimes needed to correct problems with the device.
“FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” said a statement from Steven Silverman, head of regulatory compliance at the FDA’s device center. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”
It’s far more common for the FDA to go after a manufacturer of medical devices than the providers of health care services for alleged marketing violations.
In an email to Shots, an FDA spokeswoman said the agency “is not aware of Allergan’s involvement in these specific issues addressed in the warning letters.” Rather, she wrote, “the issue is that the advertising by these organizations does not present appropriate risk and use information, which means that the advertising is misleading.”
Allergan didn’t immediately respond to Shots’ request for a comment.
When I dialed 1-800-GET-THIN myself in search of a comment, an automated greeting from celebrity physician Drew Pinsky touted the FDA approval of the Lap-Band, saying it was “extremely effective.”
Pinsky’s message also said losing weight confers health benefits, but his message said nothing about risks from the surgical procedure or the need to avoid binge eating afterward.
In a separate call, I reached Robert Silverman, an official with 1-800-GET-THIN, who asked that I email my questions about how the company plans to respond to the FDA. I did, but didn’t hear back right away.
The companies have 15 days to answer the FDA in writing.
“Misleading advertisements erode the ability of the majority of the public, who are currently either overweight or obese, to fairly consider alternative weight management options, and for ‘normal’ weight individuals to be concerned about behavior that increases risk of weight gain.”
He recommended that FDA take enforcement action. Now it has.