New Balloon Device to Treat Obesity

Two surgeons preparing for surgery, looking at medical equipment
Performing endoscopy. XiXinXing/Getty Images

On July 28, 2015, the U.S. Food and Drug Administration (FDA) announced approval of a new temporary balloon device for the treatment of obesity. This device would allow for obesity treatment without the need for invasive weight-loss surgery (also known as bariatric surgery).

Anti-Obesity Balloon Device

The new device is known as the ReShape Integrated Dual Balloon System (ReShape Dual Balloon), and is intended for adult patients with obesity.

According to the FDA news release, “The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.”

An endoscopic procedure is required to place the device, which is inserted into the stomach through the mouth and esophagus. This procedure is performed on an outpatient basis, and, according to the FDA, “usually takes less than 30 minutes while a patient is under mild sedation.”

Once the balloon device is in place, it is inflated using a sterile solution. This then causes the balloon to fill part of the stomach.

As noted by the FDA, “The device does not change or alter the stomach’s natural anatomy,” and patients are encouraged to “follow a medically supervised diet and exercise plan to augment their weight loss efforts” while using the device. This helps to ensure that patients are able to maintain their weight loss once the device is removed.

The device is meant to be temporary and, according to the FDA, should be removed six months after it is first inserted.

For Whom Is It Intended?

The FDA news release states that the ReShape Dual Balloon device is indicated for weight loss in adult patients with obesity who have a body mass index (BMI) of 30 to 40 kg/m2, and who have at least one obesity-related condition, such as high blood pressure (hypertension), diabetes, or high cholesterol, among others.

These patients must have already tried to lose weight through diet and exercise alone.

How Effective Is It?

In a clinical trial of 326 patients with obesity and at least one obesity-related condition, the individuals who were randomly selected to receive the balloon device lost an average of 14.3 pounds, or 6.8% of their total body weight. This was more than double the weight loss of the control group (those who did not receive the device).

In another study, 60 patients underwent placement of the dual balloon device, with an average weight loss of 15.4% of their total body weight. The study investigators found that the device was relatively well tolerated with few complications.

What Are Potential Side Effects?

The FDA notes that “potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure.”

The FDA also notes that “in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur” due to the procedure itself. Once the device is in place, potential side effects include nausea, vomiting, abdominal pain, feelings of indigestion, and gastric ulcers.

Who Should NOT Get the Device?

According to the FDA, patients who have had previous bariatric surgery or gastrointestinal surgery (surgery of the digestive system) should not receive this device.

The device is also contraindicated in patients who have inflammatory bowel disease (such as Crohn disease or ulcerative colitis), large hiatal hernia, active H. pylori infection, or delayed emptying of the stomach (as may be seen in diabetes).

Patients who are pregnant or who use aspirin daily should also not receive the device.


FDA News Release. FDA approves non-surgical temporary balloon device to treat obesity. Accessed online at on July 29, 2015.

Ponce J, Woodman G, Swain J, Wilson E, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2014 Dec 16. [Epub ahead of print]

Lopez-Nava G, Bautista-Castaño I, Jimenez-Bañnos A, Fernandez-Corbelle JP. Dual intragastric balloon: single ambulatory center Spanish experience with 60 patients in endoscopic weight loss management. Obes Surg 2015 May 16. [Epub ahead of print]

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