Obalon Balloon System. Screenshot from FDA recently approved medical devices web page.
This news release about a weight loss device recently approved by the FDA provides a basic description of the results of a trial, but doesn’t put them into context. The Obalon intragastric balloon is very similar to other inflatable balloons that are placed in the stomachs of patients with obesity to help them limit food intake temporarily while they try to change their diets and lifestyle. The release fails to clearly explain that the main difference between the Obalon device and other balloons is that patients are not sedated during insertion. The release does not make clear that since the trial did not compare this device to others, there is no evidence about the relative performance of this product. The release does not tell readers that the manufacturer sponsored the trial. It does not point out that this sort of conference presentation is not put through the peer review process of a journal article.
A HealthDay story on the device, also reviewed by HealthNewsReview.org, provided some details not found in the news release, including a mention that the results are preliminary and have not yet been peer reviewed and a brief discussion of harms. However, neither the news release or the news story shared that the study was sponsored by the device manufacturer.
People who have obesty want to know not only how well an intervention helps them lose weight, but how long the benefits last and how they compare to other options. By neglecting to provide context, the release does not give readers a useful understanding of the trial results.
The release does not discuss costs. Although the manufacturer has not revealed the price it plans to charge in the U.S., the Obalon device is on the market in Europe and Mexico, where prices, including office procedures, range from $2,500 to $4,000. It should be noted that prices for medical devices in the US are generally higher than those charged in other countries.
We will give the release a satisfactory rating because it notes that after one year patients receiving the Obalon balloon and counseling had lost about 7 percent of their total body weight (or about a quarter of their “excess” weight) compared to a bit less than 4 percent total weight loss for those given a sham balloon and counseling. However, since other intragastric balloons are already on the market, most people would want to know how the Obalon device compares. The release should have noted that because the trial did not include competing devices, there is no evidence that indicates whether the new device is any better or worse than other devices.
Although the release reports that one trial participant had a gastric ulcer and almost all reported mild to moderate cramping and nausea, the release doesn’t warn readers that this sort of balloon could cause serious, even fatal, complications including esophageal tears, intestinal blockages that require surgery, life threatening allergic reactions, heart attack, cardiac arrest or airway blockage. The FDA approved a package insert that lists these potential risks (see page 11 of the Patient Labeling). The release should have also mentioned the most important risks.
The release describes key aspects of the randomized, sham-controlled trial. However, here again, readers should be told that the study did not compare the Obalon device to other intragastric balloons or other obesity treatments, so it does not provide any evidence with which to compare treatment options. The release commits a serious omission by failing to alert readers that because the release is based on a conference presentation, the study report has not been subject to the type of peer review and editorial standards required of research articles accepted by major journals. The lack of detail in the conference abstract raises important questions about the trial, and the news release leaves them unanswered.
The release does not engage in disease mongering. Instead, it notes that the Obalon device was tested on people with a BMI of 30 or higher. Also, a quote talks about the device being offered to people “who otherwise would not seek treatment or not have as good a result with diet and exercise alone.”
The release fails to report that the manufacturer, Obalon Therapeutics, was responsible for the trial or that the “Study Chair” listed on ClinicalTrials.gov is a company employee.
The release tells readers that the trial results indicate the balloon and counseling were more effective than lifestyle counseling alone. It also says that bariatric surgery is the most effective obesity treatment and it does refer to “other intragastric balloons.” However, these vague references to alternatives do not provide readers meaningful information, especially since the release never specifically notes that the trial did not compare this balloon to other similar devices.
It’s worth noting that behavioral weight management programs generally result in 5-10 percent weight losses at 6 months to 1 year. When comparing Look AHEAD’s (a lifestyle intervention program) one year data, average weight loss was greater than achieved with Obalon at 8.6 percent.
The release says that the Obalon device was approved by the FDA in September, so readers might be able to guess that it will be available in the U.S. relatively soon. The release could have noted that the manufacturer will start selling it in this country in January 2017, and that it has been on the market in Europe and other countries for almost three years.
By omitting any details about the difference between the Obalon device and similar intragastric balloons, it is impossible for readers to know what is new about this device. The release could have noted that while the Obalon device is swallowed without an endoscopic procedure or sedation, the ReShape and Orbera balloons require endoscopic placement under mild sedation, and that all three devices require endoscopic removal. Also, it could have told readers that the Elipse brand balloon, which is available in Europe, is swallowed and then eventually excreted, so it normally does not require any endoscopic procedures.
The release doesn’t rely on sensational language. However, it could mislead some readers about the devices benefits and soft-pedal its potential harms through this quote: “The significant weight loss achieved with the Obalon 6-Month Balloon System is maintained at 12 months,” said Aurora Pryor, MD, study co-author and Chief Bariatric, Foregut and Advanced GI Surgery, Stony Brook University. “This combination of lifestyle modification and balloon therapy provides a new low risk option for patients struggling with obesity.”
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