(CBS/AP) The FDA has officially warned eight California surgical centers and the marketing firm "1-800-GET-THIN LLC" over "misleading" advertising for the "Lap-Band" obesity device.
The FDA said the ads - some of which appear on billboards- make claims such as "I lost 90 pounds with the Lap-Band!" or "Ready to be the next weight-loss success story?" but leave out mandatory information about side effects and surgical risks.
The Lap-Band - made by Allergan Inc. - is a stomach-restricting band that limits food intake. Sometimes referred to as a gastric band, the device is a silicone band placed around the upper portion of the
stomach to create a smaller pouch, so people feel full faster,
eat less, and lose weight. The band is used when non-surgical weight loss methods like diet and exercise
But it can also cause infection, nausea, vomiting, and irritation of the esophagus. The FDA said messages about those risks on current ads "appear so small as to render the information illegible."
The companies have 15 business days to respond and lay out plans to correct the advertisements.
In February the agency expanded Lap-Band's approval to an additional 26 million American patients with a body mass index (BMI) between 30 and 40 and one weight-related medical condition, such as diabetes or high blood pressure. That's up from the 15 million patients who were eligible under the previous criteria: BMI of 40 or higher, or 35 and higher with weight-related complications. More than a third of all American adults are obese.
Previous research suggests gastric band surgeries can cause complications, leading to more surgeries or removal of the device,
WebMD has more on gastric banding surgery for weight loss.