Two Gastric Balloons Approved By FDA

September 21, 2015

In a landmark month for obesity devices, the ReShape Integrated Dual Balloon System and the Orbera Gastric Balloon were both approved by the US FDA for use in obese individuals. While the approval of these two balloons represents a critical step forward for the treatment of obesity in the United States, the devil may be in the details.

But first, the good stuff: both balloons have been shown to lead to more weight loss than just dieting in large, well-designed clinical trials. Moreover, participants in the ReShape FDA study who were followed for 6 months after their balloons were removed maintained 66% of the weight they had lost. In addition, balloon therapy led to an overall improvement in health, including lower cholesterol, blood pressure, and markers for diabetes.

However, the ReShape and Orbera balloons have their limitations:

-In 1-2% of participants, balloon removal caused serious adverse events including: esophageal tearing, esophageal perforation, and aspiration pneumonia.
-In 35% of ReShape participants, balloons caused ulcers in the stomach
-In 100% of participants, some sort of sedation or anesthesia was required

The Elipse Balloon was designed to lead to similar weight loss as these two balloons without the risks and costs associated with endoscopy and anesthesia. Specifically, due to its self-emptying design, the Elipse Balloon does not require a complicated and potentially risky removal procedure. While the risks associated with the ReShape and Orbera balloons may be acceptable to some, a procedureless device like the Elipse Balloon may be a safer and more attractive option for many.