Americans are constantly on the prowl for the next quick-fix weight loss solution, and last week they found it in a pill that inflates into a balloon in your stomach. The idea is that the balloon fills up part of your stomach, forcing you to eat less over the three months it will remain there, until it is extracted backwards through the throat.
While this idea seems like a simple solution to the trials and tribulations most people face when it comes to dieting, it’s not quite the magic bullet many people crave. For one thing, it’s not available in the United States — the Food and Drug Administration has not yet approved it — and the company behind the balloon pill, Obalon, is still conducting tests to prove its efficacy. The pill is available in Europe, and just became available in the U.K. (spurring the media flurry), though it can cost up to £4,000, or $6,500. Moreover, because it’s technically a device and not a medication, the standards for proving its efficacy are much lower, leaving some doctors wondering whether it’s worth it.
Problems with the Balloon Pill
“The balloon is a very old idea,” said Daniel Bessesen, MD, professor of medicine at the University of Colorado School of Medicine, member of the Endocrine Society, and chief of endocrinology at Denver Health Medical Center. “The first clinical trials were in the 1990s, and the results were quite discouraging.” Many people experienced pain, nausea and vomiting with the balloon, and sometimes the balloon could either inflate in the throat, collapse, or move into the small intestine, requiring surgery for its removal. The new Obalon pill does not require a surgery, but does require an endoscopic removal (taking it back out through the mouth), during which the patient will be sedated.
Obalon actually uses smaller balloons than those of the past, and a patient can decide if she wants one, two or three balloons, which would be placed in the stomach incrementally over time. The balloons are also filled with gas rather than saline, which keeps it buoyant in the stomach.
Dr. Bessesen said he still worried that the device might necessitate an emergency surgery in the event it got caught. “There are diet options that can work and won’t put you at risk of surgery,” he said. Obalon lists the possible side effects as initial cramping and discomfort and possible nausea and vomiting, noting that people will have to take acid-reducing medication while using the product. PubMed, run by the National Institutes of Health, warns that possible complications could include injury to the stomach or esophogus, a gastric ulcer, or “deflation of the balloon (which could result in bowel obstruction — which can be potentially fatal).”
Weight management falls into three categories: diet and exercise, medication and devices, Bessesen said. Medications tend to incur a 10 percent weight loss, surgery can incur between 15 to 30 percent weight loss, and experts predict the new pill could incur loss somewhere in between these two options. In an Obalon trial, the average weight loss was 16 pounds for obese women over the three-month period, according to PubMed.
Putting a balloon in the stomach is somewhat similar to getting a gastric bypass, as it fills up part of the stomach making it actually difficult to overeat. It’s not exactly the same, because a gastric bypass not only shrinks the stomach, it also alters how food is absorbed in the small intestine, noted Caroline Apovian, MD, director of the Center for Nutrition and Weight Management at Boston Medical Center.
“It’s not a temporary bypass — it’s a temporary partial bypass,” Dr. Apovian said.
PubMed recently posted an article about Obalon, concluding that: “As yet little research into the effectiveness of this recent product has been undertaken. It may help weight loss but is unlikely to be a magic cure for obesity.”