Wednesday, February 16, 2011

Weight Loss Surgery for BMI 30?

As you may know, the standard recommendation has been that bariatric surgery is indicated for BMI 35 or above, in the presence of at least 1-2 comorbidities. In the US, patients whose BMI is between 30 and less-than-35 have hard time being accepted for weight loss surgery and, by and large, have had no surgical option.

One bariatric surgery, adjustable gastric band placement, involves the placement of a device that is produced by Allergan (Lap Band). In an Allergan News Release, the U.S. Food and Drug Administration (FDA) approved the expanded use of the LAP-BAND® System, Allergan’s gastric band, for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. The LAP-BAND® System study, initiated by Allergan, Inc., is a prospective, single-arm, non-randomized, multi-center five year-study. The study was initiated in 2007, and included 149 patients. The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month time point, where clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL).

The 12-month results showed that almost 84% of the patients lost at least 30% of their excess weight at one-year. In terms of improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension, 22-33% of patients with those conditions, saw their conditions resolved after one year.

Comparing the Lap Band with non-surgical weight loss (which has very low success rates), and setting the threshold of "success" to the level of losing 30% excess weight, allowed those results to shine. However, if those were compared to sleeve gastrectomy (1-2 year average excess weight loss of 60-68%, and 5 year average loss of 50% excess weight) such a standard for success would not be met by the Lap Band. But the sleeve gastrectomy is a surgical procedure, not involving the implantation of a device. Therefore, there is no basis for FDA to have any saying about the sleeve gastrectomy or gastric bypass. It is safe to say that the improvement in comorbidities is, on the average, much better with the sleeve gastrectomy than the adjustable gastric band.

Will bariatric surgeons become more encouraged to apply the same BMI guideline of 30 for other bariatric surgeries (instead of 35) based on the FDA approval of the Lap Band? Would they be supported by the American Society of Bariatric Surgery if they do so? Will insurance companies change their coverage criteria based on that? So many questions. But it is a good start.