A Lap-Band for every pot belly? Health journalists, patient advocates pay heed

Health journalists and patient advocates should be on high alert for the changes that are sure to come with the announcement last week that the FDA has approved the Lap-Band device for nearly every person with a few pounds to lose.

Want to know if you'd be a candidate for a Lap-Band? The Los Angeles Times provided a helpful graphic showing the body types that used to qualify for the more restrictive FDA guidelines and the now, much slimmer, body types that fall under the new guidelines. The device's maker, Allergan, stands to reap billions in future profits. The size of its customer base just grew from roughly 6% of the population to more than 30%.

Antidote has written over the past few weeks about some of the shady marketing tactics used by some clinics that perform the Lap-Band surgery and the ways that Allergan helps promote those clinics. Now the competition is really going to crank up for this much larger weight loss market.

Here are three things to watch for.

1. Your hospital starts a "Weight Loss Center of Excellence." Expect more hospitals, especially the smaller players in the suburbs of your community, to devote coveted floor space or even brand new buildings to weight loss clinics and surgery centers. My guess, though, is that they will bill these as "full service" weight loss centers with dieticians, physical therapists and specialists in non-surgical bariatric medicine to help people lose weight and keep it off. The proof will be in how they actually staff the clinics, how much of their resources they devote to the surgeries and how they use third-party marketers using lowbrow techniques to funnel patients back to the hospital.

2. More doctors with no certification in bariatric medicine or surgery get into the game. By the end of 2010, it is guaranteed that doctors who are today offering laser hair removal or painkiller prescriptions with no questions asked will be claiming expertise in Lap-Band procedures. Allergan does require doctors to take training from the company in the procedure in order to be featured as an Allergan-certified physician, but this is not same as being board-certified in bariatric medicine or board-certified in surgery. Check the doctors whose names start showing up on billboards and in advertisements in magazines promising "The City's Best Doctors!"The startling headlines from the Los Angeles Times recently citing four recent patient deaths in Los Angeles from Lap-Band surgeries all track back to the same clinics using sleazy marketing campaigns like "Diets Suck" and "Diets Fail" to lure people to have the surgery. Many of these doctors don't have the credentials they should and have been in trouble with state medical boards.

Which brings us to

3. More dead and injured patients. This isn't a slight against Allergan or its product. In controlled settings, Lap-Bands have very low mortality rates, less than 0.5% according to a 2009 study. But not all surgeons are the same, especially if they don't have the right training (see No. 2). This may be why other complications abound. A 2006 review of a decade of Lap-Band studies found that on 317 patients undergoing the surgery, one-third "developed late complications such as band erosion, pouch dilation, band slippage, and catheter and port related problems. Major re-operations were required in 21.7% of all patients and the failure rate consistently increased from 23.8% at 3 years to 31.5% at 5 years, up to 36.9% at 7 years." What's worse,"The 7-year success rate (defined as excessive weight loss of more than 50%) was extremely low (43%)." The authors wrote, "laparoscopic banding should no longer be considered as the procedure of choice for obesity."

This is really Allergan's chance to prove the doubters wrong, and it will be interesting to watch how the company navigates this very different market. No longer forced to target the morbidly obese, they essentially can market the Lap-Band the same way Pfizer has marketed Viagra. Watch for Superbowl ads. And when you see them, remember what Ulrich Guller and colleagues found in 2009:

There is mounting and convincing evidence that laparoscopic gastric banding is suboptimal at best in the management of morbid obesity. Although short-term morbidity is low and hospital length of stay is short, the rates of long-term complications and band removals are high, and failure to lose weight after laparoscopic gastric banding is prevalent.

Is a Lap-Band right for every pot belly in America? It's up to health writers, patient advocates and bariatric medical specialists who don't push surgery as the first option to help answer that question.