On Friday, the Food and Drug Administration (FDA) will consider a request by Allergan — the company that manufactures the Lap-Band device used in the majority of gastric banding surgeries in the U.S. — to lower the bar for eligibility for the weight-loss surgery, the New York Times reports.
Currently, patients who want gastric banding must have a body mass index (BMI) of 40 or higher, the clinical definition of morbid obesity; they can have a BMI of 35 or higher, if they also have at least one serious obesity-related health problem, such as diabetes or high blood pressure. They must also demonstrate that they have tried and failed to lose weight through changes in diet and exercise. (More on Time.com: Weight Watchers’ New Points: Zero for Most Fruits and Veggies)
Allergan would like to lower these requirements to a BMI of 35 for any patient, or 30 and above for people with serious health problems, according to the Times article.
In support of its request, Allergan (better known as the maker of Botox) recently released the results of a clinical trial it supported that demonstrated the benefit of Lap-Band surgery on the less obese. The trial followed 143 patients with BMIs between 30 and 40; 80.5% of them had lost 30% of their body mass one year after surgery.
The FDA is currently reviewing that study along with others to determine if it will recommend the device for less obese patients — a move that could double the eligible population for bariatric surgery. Some doctors advocate the change, saying that the benefits of such surgeries extend beyond weight loss to the improvement of other conditions. Andrew Pollack of the Times writes:
Doctors have already started to operate on extremely heavy teenagers, not just adults. And some experts are recasting weight-loss procedures, known as bariatric surgery, as metabolic surgery, saying that it might be justified to treat diabetes, even in people who are barely obese or not obese. Gastric banding involves placing an inflatable silicone ring around the upper part of the stomach, which limits food consumption and makes one feel full faster.
Many people who suffer from obesity-related diseases like diabetes and hypertension have BMIs as low as 30. “There are people who have been diagnosed with co-morbidities from their obesity at a lower levels of body mass index that was is typically considered obese,” Dr. Mitchell Roslin, chief of bariatric surgery for Northern Westchester Hospital, said in an email to TIME. “For example, they may have a BMI of 32 but still have health issues associated with obesity such as diabetes or heart disease.” (More on Time.com: Do Overweight People Smell Food Better?)
However, gastric banding surgery, which involves limiting the size of the stomach by placing a silicone ring around its upper part, is associated with significant side effects such as vomiting and abdominal pain and can be fatal in rare circumstances. Also, patients have a hard time keeping weight off long-term. Pollack reports:
The F.D.A. indicated on Wednesday that it had questions about how meaningful the weight loss was and whether the results of the study would be applicable to people other than the white women who made up a large portion of the participants.
Some doctors are dropping the band, in part because some older studies suggest that up to a third of patients eventually have the band removed because of side effects or ineffective weight loss. While about one in 1,000 patients die within 30 days of surgery, a survey of members of the bariatric surgery society suggested that deaths occurring later are under-reported.
Because major surgery carries significant risks and potential complications, which already put off many eligible patients, some experts say that even if the FDA expands the patient pool for gastric banding, there will not be a deluge of increased interest in the procedure. The FDA may come to a decision as soon as Dec. 3.