The Food and Drug Administration (FDA) in late February approved new guidelines that make millions of additional Americans eligible for Lap-Band surgery, providing a potential windfall for surgeons who specialize in the procedure. But some experts question the way the procedure is being marketed to overweight and obese patients.
The FDA lowered the minimum body mass index for Lap-Band surgery candidates from 35 to 30 so long as patients have at least one other obesity-related illness such as diabetes or high blood pressure. The change doesn't seem like much but according to some estimates, it qualifies up to 26 million additional overweight people in the U.S. for the surgery.
The decision presents a great revenue opportunity for providers, but some surgeons are concerned the new guidelines will produce a rush of "surgery mills" that promote the procedure as an easy fix. "The Lap-Band is the safest approved surgical procedure for weight loss, but traditional advertising doesn't send the right message," bariatric surgeon Ted Khalili told the Los Angeles Business Journal.
One ad campaign in California has come under scrutiny and has been hit with several lawsuits. The marketing campaign in Los Angeles uses billboards with the phone number 1-800-GET-THIN to promote Lap-Band surgery and refers callers to surgeons associated with the program. In February, a San Fernando Valley surgical center was sued by the husband of a woman who died after Lap-Band surgery and three other lawsuits are pending against the program.
In December, the Los Angeles Department of Public Health (LADPH) asked the FDA to look into the 1-800-GET-THIN campaign and others like it to determine whether they provide enough information about the risks involved in the surgery. "The advertising of this medical device by 1-800-GET-THIN Weight Loss Centers inadequately informs consumers of potential risks," wrote LADPH director Jonathan Fielding in a letter to the FDA.
A spokeswoman for Allergan, the manufacturer of the Lap-Band, said the company is in no way affiliated with the marketing campaign. An LA Times columnist tracks the campaign to a Beverly Hills clinic.
Bariatric surgeons such as Khalili, who has performed the Lap-Band procedure hundreds of times, worry that provocative campaigns like 1-800-GET-THIN promote surgery as a shortcut to weight loss. "The surgery is almost a secondary thing," said Khalili. "To make the operation successful, you have to have a lot of education and support before and after so that patients continue to make the right decisions to improve their health."
There's no doubt the FDA decision will generate a slew of new marketing efforts to promote the procedure, which usually requires an overnight stay in the hospital and can cost up to $30,000. The American Society of Metabolic and Bariatric Surgery estimates that gastric banding accounted for 40% of all gastric surgeries in 2009, a percentage that's expected to soar now that millions of new patients are eligible for Lap Bands.
But the legal woes of the 1-800-GET-THIN program should serve as a warning for all healthcare providers not to get caught up in marketing campaigns that provide an incomplete picture of any procedure and its inherent risks.