FDA Approves Gastric Balloon to Treat Obesity
The Food and Drug Administration (FDA) has approved the ReShape Integrated Dual Balloon System as a weight-loss treatment option for obesity. Those who qualify for the treatment are obese adults with a BMI in the range of 30 to 40, who have not seen successful weight-loss results by modifying their lifestyle. Its use also would be limited to people with one or more obesity-related conditions, such as high blood pressure.
The Dual Balloon comprises two balloons that are inserted into the stomach and inflated. Surgery is not needed; the insertion is completed instead as an outpatient visit while the patient is mildly sedated. The doctor inserts the device using an endoscopic tube. Once properly placed, the Dual Balloon is inflated using a sterile salt solution. The Dual Balloon is meant as a temporary treatment and should be removed after six months.
While the Dual Balloon does not change the anatomy or size of the stomach, it is intended to work by making patients feel fuller faster. Patients must also adhere to a medically supervised diet and exercise regimen in addition to using the Dual Balloon—both throughout the course of the six-month treatment and after it’s removed.
The FDA approved the device after reviewing a clinical trial of 326 obese patients from ages 22 to 60 whose BMI was in the range of 30 to 40 and who had at least one obesity-related condition. Some randomly received the Dual Balloon and others acted as a constant. After six months, the 187 patients who received the Dual Balloon lost 14.3 pounds on average, or 6.8 percent of their body weight. The control group, by comparison, lost an average of 7.2 pounds. Six months following the device removal, people who used the Dual Balloon were able to keep off 9.9 pounds.
As with all medical devices, there are potential side effects, including nausea, vomiting, feelings of indigestion, abdominal pain and stomach ulcers. The Dual Balloon is not suitable for IBD patients, pregnant women, or people with active H. pylori infection, among others.