Balloon

FDA Approves 6-Month Dual Balloon for Obesity

Late yesterday, FDA approved the first of two gastric balloon devices under review to treat obesity. The ReShape dual balloon is the first new treatment for obesity to be approved for explicitly short-term use — it must be removed after six months or less.

On the plus side, it would appear to fill a significant gap for people with a BMI between 30 and 40 who are not finding any relief for obesity from behavioral treatment programs or drug therapy. In fact, the FDA-approved labeling does not suggest that candidates for this gastric balloon should have tried drug treatment before considering the balloon.

The system also has the advantage over bariatric surgery of being placed into the stomach with an endoscope through the mouth. There’s no surgery, only sedation, so it’s generally an outpatient procedure. For people who cannot or will not opt for bariatric surgery, it’s a reasonable intermediate option.

On the minus side, it appears to be less effective than gastric bypass or gastric sleeve surgery. Clinical trial results in the labeling suggest that patients lost an average of 25% of their excess body weight, compared to people who received a fake procedure and lost only 11%.This rate is similar to the efficacy reported with the vagal nerve blocking device (VBLOC) approved earlier this year, though the sham controls in that study had an initially higher response.

Another gastric balloon device — the Orbera single-balloon device — is under review at FDA and expected to be approved soon.

The real question is how these options will fit into the practice of evidence-based care for people with obesity. John Morton, President of the American Society for Metabolic and Bariatric Surgery, welcomed the news, saying:

Options like ReShape address a significant gap that exists between diet and exercise, weight loss medications and surgery, offering a minimally invasive, reversible option which we hope will promote long-term healthy habits.

Long-term is key. Obesity is a complex, chronic disease driven by powerful biologic forces. Six months after removal of the device, the effect faded and excess weight loss came down from 25% to 18%. This is no surprise and clinicians will need to develop sound strategies to build upon the short-term benefits these temporary devices can offer.

It’s good to have a tool. It’s even better to have a long-term plan.

Click here to read more from Medical Daily, here for the FDA press release, and here for the detailed product labeling.

Balloon, photograph © jar (away) / flickr

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July 29, 2015

2 Responses to “FDA Approves 6-Month Dual Balloon for Obesity”

  1. August 02, 2015 at 1:50 pm, Shantanu Gaur said:

    Ted,

    Thank you for the post. The data for balloons in the pre-market and post-market settings is quite different. For example, ReShape conducted a post-market study in Spain (Lopez-Nava et al., 2015) in paying patients receiving highly customized follow-up and achieved a 47% excess weight loss and 15% total body weight loss (double what was achieved in the FDA study).

    The goal of a sham-controlled weight loss study is to beat the sham for regulatory purposes by using relatively light follow-up, not publish the greatest weight loss possible. In a post-market setting without a sham, a full follow-up program can be implemented with paying patients. The results in the post-market setting probably reflect actual weight loss in the field more accurately. This dichotomy appears frequently in other studies on gastric balloons for weight loss.

    Thank you as always for your thoughtful commentary–

    Best,
    Shantanu

  2. August 02, 2015 at 5:40 pm, Ted said:

    Thanks for providing good additional insight, Shantanu.