FDA Approves ReShape Dual Balloon Device to Treat Obesity

Disclosures

July 28, 2015

The US Food and Drug Administration (FDA) today approved a new nonsurgical weapon in the fight against obesity — a pair of connected saline-filled balloons that are temporarily implanted in the stomach to trigger a feeling of fullness and jump-start weight loss.

The device, called the ReShape Dual Balloon (ReShape Medical), is inserted endoscopically through the mouth and then filled with saline solution. The outpatient procedure takes less than 30 minutes while the patient is mildly sedated.

The FDA said that the satiety-inducing ReShape Dual Balloon does not alter the stomach's natural anatomy. The intragastric device, which should be removed after 6 months, is meant to accompany a medically supervised diet and exercise program. It is indicated specifically for obese adults with a body mass index of 30 to 40 kg/m2 with one or more obesity-related conditions such as diabetes who have failed to lose weight through diet and exercise alone.

"For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, in a news release. "This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed."

Physicians in other countries such as Canada, Italy, France, and Brazil have used intragastric, saline-filled balloons for years to treat obesity. The ReShape Dual Balloon has been available in the European Union since December 2011, according to the manufacturer.

The FDA determined that the ReShape device was safe and effective based on a clinical trial involving 326 obese participants aged 22 to 60 years who had at least one obesity-related condition. One hundred eighty-seven participants randomly selected to receive the ReShape Dual Balloon had lost 14.3 pounds on average when the device was removed at 6 months. They had kept off on average 9.9 pounds of that lost weight at the end of the following 6 months. The remaining participants who underwent a sham endoscopic procedure without the insertion of the device lost on average 7.2 pounds after 6 months.

Headache, muscle pain, and nausea from sedation are potential adverse events for the balloon insertion procedure. "In rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur," the agency said.

Adverse events associated with the ReShape Dual Balloon filling up part of the stomach for 6 months include vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.

The FDA cautions that clinicians should not implant the device in patients who:

  • Have had previous gastrointestinal or bariatric surgery

  • Have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying, or active H. Pylori infection

  • Are pregnant

  • Use aspirin daily

More information on today's announcement is available on the FDA website.

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