FDA Issues Warning About Misleading Lap-Band Ads

The U.S. Food and Drug Administration issued warning letters to the California-based marketing company 1-800-GET-THIN LLC and eight California surgical centers for using misleading advertising to promote Lap-Band surgery for weight loss.

The advertising in question, including billboards, inserts, newspaper ads and bus placards, features thin models and such seductive claims as “Let Your New Life Begin!” and “I Lost 90 Pounds with the Lap-Band!” but fails to adequately list the required warnings, precautions, possible side effects and contraindications associated with the surgery. Where the warnings do appear, they are in a type size too small to be read by consumers.

“The FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” said Steve Silverman, director of the Office of Compliance in the 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.”

By federal law, product advertising for certain medical devices such as the Lap-Band must list warnings and risks. The FDA is prepared to take action against the affected companies if they do not change their advertising and promotion strategies, including product seizure and financial penalties.

In an effort to ensure that Lap-Band advertising is carried out according to the law, Lap-Band manufacturer Allergan has voluntarily issued a set of guidelines calling for doctors who use the device to present “balanced information about the benefits and risks related to the procedure.”

Allergan’s FDA-approved Lap-Band is a silicone device placed around the upper part of the stomach to create a small pouch. The narrowed opening between the pouch and the rest of the stomach controls how quickly food passes to the lower part of the stomach, limiting the amount of food that can be eaten at one time and helping the patient feel full.

An alternative to the more radical gastric bypass surgery, Lap-Band surgery is not without its risks. Said Herbert Lerner, M.D., a general surgeon and supervisory medical officer at the FDA: “Surgery has risks, including death, and those risks are heightened for people who are obese.”

And the risks are real. According to the Los Angeles Times, five patients in Southern California have died since 2009 after undergoing weight-loss surgery at centers affiliated with 1-800-GET-THIN. Time.com reports that studies have shown that Lap-Band patients suffer a high rate of complications, both major and minor. A March study found that 40 percent of patients experienced serious complications following surgery. An additional 22 percent had minor complications, and 60 percent needed subsequent surgery. Complications following surgery can include nausea and vomiting, upset stomach or pain, difficulty swallowing, gastroesophageal reflux disease, and the more serious problems of band shifting or erosion, both requiring additional surgery.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”


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