The New York Times recently published an article about how obese people are going to Canada to receive the intragastric balloon weight loss device, which is not approved for use in the United States. The intragastric balloon is a small balloon-like device that is inserted in the stomach and is filled with liquid, providing a sense of satiety (fullness). It can be left in the stomach for up to six months. The balloon is appealing to people who have a significant amount of weight to lose but are not heavy enough to qualify for bariatric surgery, such as gastric bypass surgery or lap band surgery. It is a relatively non-invasive procedure: the balloon is inserted into the stomach endoscopically through the mouth, and then it is removed in another similar procedure after about six months.
While the intragastric balloon is not yet approved by the FDA, several small studies on its safety and effectiveness have been performed in the Unites States. Last year at the American Society for Metabolic and Bariatric Surgery (ASMBS) national meeting, we reported about a session on emerging medical technology, where talks on new concepts, investigational devices, and late-breaking research were presented. The session featured results of a randomized trial, evaluating the safety and efficacy on the intragastric dual balloon in obese patients. The device appeared to be safe and induce some weight loss. Additionally, results of a pilot study were presented, in which patients received an intragastric balloon by swallowing it. The patients in the small study did lose some weight at the very short-term follow up of 30 days.
There is also an on-going clinical trial that may lead to FDA approval, but many Americans are not willing to wait for the device. According to the article, Americans account for nearly a third of patients undergoing the procedures in Canadian clinics just across the border. However, while the procedure is not as invasive as surgical options, there are several potential complications–-ranging from nausea and vomiting, ulcers and infections, to life-threatening issues like obstruction and stomach perforation. Additionally, weight loss with the balloon has been found to be modest, at best. Research has shown weight loss results ranging from 13–34 pounds on average, with some people losing up to 50 pounds. Weight regain after the device is removed is also a concern. The combination of these potential risks and limited benefit is the primary reason that the intragastric balloon is not approved in the United States. Dr. Robin Blackstone, president of the ASMBS is involved in a clinical trial of the balloon and commented that people “who need to lose a modest amount of weight may do just as well with a more conventional approach, given the risk of complications”. People should understand that successful weight loss with the intragastric balloon requires lifestyle changes, including a better diet and increased physical activity. If these changes are not maintained after the balloon is removed, weight regain will likely occur.
Dr. Mark Fusco, Medical Director of Lifeshape Advanced Bariatics in Florida, bariatric surgeon and an investigator in the largest US study evaluating the intragastric balloon, echos Dr. Blackstone’s statements: “The intragastric balloon is unique among presently available weight loss procedures in that the device is meant to be implanted for only 6 months. This heightens the importance of incorporating very significant dietary, behavioral, and activity changes if patients hope to effect long term weight loss. Only certain patients optimally benefit from this procedure versus nonprocedural or more invasive procedures. It would be nice if US surgeons had this procedure in our armamentarium to offer to patients. In the mean time, I would caution patients to consult with a bariatric surgeon familiar with the procedure prior to undergoing intragastric balloon placement to see if this is a reasonable plan for their particular situation.”