In a clinical trial of ReShape involving 326 obese patients with a BMI between 30 and 40, patients who swallowed the pill lost an average of 14.3 pounds in 6 months—equivalent to 6.8% of their body weight. In contrast, the control group (who were told they were getting the gastric balloon but received a sham procedure instead) lost an average of 7.2 lbs, or just 3.3% of their body weight. Six months after the balloon was removed, the pill group managed to keep off an average of 9.9 pounds of the 14.3 they lost. Another study published in the journal Obesity Surgery found that the balloon improves liver function and insulin resistance in obese patients.
In early trials, the Ellipse has led to a 22-pound loss after 4 months, and significant improvements in triglycerides and A1C levels, which are risk factors for heart disease and diabetes.
What's the Catch?
Photograph by Ian Hooton/SPL/Getty ImagesWithout rigorous nutrition and lifestyle coaching, the procedure won't be effective, according to ReShape. Patients must adopt a healthy lifestyle—exercising more, eating better, and downsizing their meals to several small ones daily. These steps are crucial not only for the procedure to work but also to maintain weight loss once the balloon comes out.
Side effects include nausea and sometimes vomiting in the week after the gastric balloon is inflated, though these symptoms last only a few days and can be controlled with medication. While the $9,000 price tag is thousands less than that of bariatric surgery, it's still too expensive for many people—and the pill isn't yet covered by insurance.
Those aren't the only drawbacks, says Garth Davis, MD, medical director of the Davis Clinic at the Methodist Hospital in Houston and a fellow of the American Society for Metabolic and Bariatric Surgery. He worries the procedure might cause patients to develop bad eating habits.
"When this gastric balloon is in your stomach, you can't eat high-fiber foods, which means no big, healthy salads," he says. "And if you eat too much, you're just going to vomit. So a patient might say, 'Well, I can't eat a salad, but I can drink a milkshake.' You can see how that might foster really bad eating decisions."
Should You Consider the Gastric Balloon?
Photograph by Dan Burn-Forti/Getty ImagesDespite some misgivings, many weight loss surgeons see real potential for the procedure—as long as patients commit to making the lifestyle changes. Abraham Krikhely, MD, a surgeon in the division of minimally invasive, metabolic, and weight loss surgery at Columbia University in New York City, sees real potential for the pill: "While the gastric balloon is not a long-term solution, I do feel like it can help many of my patients who have a lot of medical problems associated with obesity." He likes that the procedure is minimally invasive and that most patients can return to a normal, active lifestyle within a few days.
So, who's an ideal candidate for the procedure? Someone with a body mass index between 30 and 40, which means they're morbidly obese, says Krikhely. "This is a procedure for patients who need to lose weight quickly," he says. Candidates include people who are prepping for actual weight loss surgery or need an organ transplant: Losing weight can make the surgery safer.
Hooman Shabatian, MD, one of the pioneers in bringing the gastric balloon procedure to the US, adds that many of his patients are seeing dramatic results. "More than 220,000 successful balloon surgeries have been performed worldwide. This is a viable option for those looking to lose 30 to 40 pounds," says Shabatian.
Adds Krikhely: "These gastric balloons are not meant to be the answer; they're not a long-term solution. However, in conjunction with plenty of support when it comes to educating patients about proper diet and exercise, it can be an excellent solution."