The AP reports that officials with the Food and Drug Administration (FDA) “have issued warning letters to eight surgical centers and a marketing firm in California for misleading advertisements promoting the Lap-Band, a stomach-restricting device used to treat obesity.” The agency said in a news release “that advertisements by the centers and a marketing firm, 1-800-GET-THIN, do NOT provide mandatory information about the risks and side effects of Lap-Band implantation. The stomach-restricting band — made by Irvine, Calif.-based Allergan Inc. — limits food intake, but can also cause irritation of the esophagus, infection, nausea and vomiting in some cases.”
The National Journal reports that in a statement, the FDA said that it had “issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups.”
The National Journal quotes Steve Silverman, director of the FDA’s Office of Compliance, Center for Devices and Radiological Health, who said, “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”
“The letters call for the companies to immediately halt marketing that violates federal regulations or face possible legal action including financial penalties and product seizure,” the San Diego Union-Tribune reported.
The agency’s letter to the San Diego Ambulatory Center LLC, for example, “cited two billboards and several advertising inserts the company uses that the agency said violates federal regulations.” The advertisements “don’t explain the surgical risks, age and other qualifying limitations, and the need to permanently change eating habits after surgery, the FDA said.”
According to the Orange County (CA) Register, “the companies have 15 business days to respond to the agency and show their plans to correct the ads.”
Since 2009, “five people have died … after Lap-Band surgeries at clinics affiliated with the 1-800-GET-THIN campaign, according to lawsuits, autopsy reports and interviews, the Los Angeles Times has reported.”
So, like I always say, before you take a medication or agree to any elective treatment, procedure, or surgery, find out ALL of the other options, ALL of the potential risks, ALL of the potential benefits, and ALL of the potential costs.