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FDA Sights Concerns From 1-800-GET-THIN

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Federal health officials have issued warnings to eight surgical centers in California and the advertising firm “1-800-GET-THIN” for misleading advertisements promoting Lap-Band – a medical device implanted in surgery called gastric banding which helps adults eat less and lose weight.

The letters say the ads must do a better job of describing the risks associated with lap-band surgery. The flashy advertisements on billboards, radio and television fail to provide essential information regarding the risks and side effects of lap-band devices, the FDA said.

“It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices,” said Steve 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.”

Federal law requires ads for certain medical devices – including those used in gastric-band surgery – to include information about side effects, precautions and contraindications (medical reasons that make a treatment inappropriate) that are associated with the product and to issue relevant warnings regarding use. While the billboards contain warnings about risks, the typeface is so small it’s illegible, in comparison to the large lettering for slogans like “Let your new life begin,” contends the FDA.

Since 2009, five Southern California Lap-Band patients have died following surgeries at centers affiliated with 1-800-GET-THIN. A series of wrongful death and personal injury lawsuits have been filed against 1-800-GET-THIN, its affiliated surgery centers and doctors who performed the procedures. A class-action suit has also been filed – on behalf of patients – that accuses the marketing firm of false advertising for failing to adequately disclose the risks of the surgery. Complaints also came from Allergan, which manufactures the Lap-Band device.

About Lap-Band

In February Lap-Band’s approval was expanded to an additional 26 million patients – up from the 15 million patients eligible under previous criteria – with a body mass index between 30 and 40 and one weight-related medical condition, such as diabetes. More than a third of all American adults are obese

Side effects associated with lap-band include nausea and vomiting, difficulty swallowing and severe heartburn and more. In some cases, another surgery is required to correct problems with the device.

If you are concerned that there may be a problem with a gastric banding device, the FDA urges you to file a voluntary report using the MedWatch Reporting program, which in turn will help the agency to better identify and understand the risks associated with medical devices.

Visit the FDA Web site to read more about gastric band surgery.

2 Comments

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  1. J. Garver says:
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    As a lap-band patient for the last 5 years I’ve always been troubled by the bill board ads and radio and tv spots. To me it was more about the baiting a person in and getting him/her to pay cash because insurance won’t pay if a person doesn’t meet the NIH criteria for morbid obesity. It was less about helping people that really need the help.

  2. Mike Bryant says:
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    Very good point, thanks for reading and the comment.