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FDA Approved

FDA Approved

The U.S. Food and Drug Administration (FDA) has approved the ReShape Integrated Dual Balloon System, the first-of-its-kind non-surgical weight loss procedure for people who either do not want or do not qualify for bariatric surgery. The ReShape Procedure provides a new option for those who have not achieved weight loss success through diet and exercise alone.

"Many Americans have struggled with a lack of effective weight loss options when their BMI is in the 30–40 range," said John Morton, MD, MPH, President of the American Society for Metabolic and Bariatric Surgery. "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."

The ReShape Dual Balloon is inserted in the stomach through an endoscopic procedure and filled with saline (salt water). The balloons remain in the stomach for six months and help reduce hunger, so patients feel satisfied with smaller portions. During the first six months, and for the six months after the balloon is removed, patients receive comprehensive counseling and support services that include frequent in-office coaching sessions.

Prior to receiving FDA approval, the ReShape Integrated Dual Balloon System underwent rigorous testing and academic studies. According to one study, patients who had the ReShape Procedure lost 2 times as much weight as a group who only received diet and exercise coaching. In a study conducted in Europe, ReShape patients, on average, lost 47% of their excess weight and maintained 98% of their weight loss at one year.

Besides accolades from doctors, ReShape has also earned praise from patients who’ve used the program to achieve weight loss success. "Anyone who struggled with diet and exercise to lose weight knows it can be a very frustrating cycle. Still the idea of undergoing surgery or being on medication for life is also unattractive," said Carmelia, a ReShape patient. "The ability to make long-term changes in my lifestyle with ReShape has not only changed how I see myself in the mirror, but how I see my future.*"


*Patient Results May Vary.

Call For Free Consultation 407-420-7663

Important ReShape® Integrated Dual Balloon System Safety Information

Indications: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 - 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Contraindications: The ReShape Integrated Dual Balloon System is not recommended for patients with conditions that may increase the risk of poor results (e.g., prior gastrointestinal surgery with sequelae, prior open or laparoscopic bariatric surgery, inflammatory diseases of the GI tract, potential upper GI bleeding), who are unwilling to participate in an established medically-supervised diet and behavior modification program, who have alcohol or drug addictions, who receive daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, or who currently are or may be pregnant or breast-feeding.
Warnings: The maximum placement period for the ReShape Integrated Dual Balloon is 6 months. The risk of intragastric balloon deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months. The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a sign of balloon deflation. Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric ulceration or perforation.
Adverse Events: Placement of the ReShape Integrated Dual Balloon requires an endoscopic procedure with sedation. Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), infection, pneumonia, and respiratory distress. Potential risks associated with the ReShape Integrated Dual Balloon include ulceration, perforation, abdominal pain, nausea, vomiting, bloating, belching, heartburn, dehydration, and sore throat. These complications may be severe enough to require early removal of the ReShape Integrated Dual Balloon. Although the ReShape Dual Balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction. The risk of intestinal obstruction is increased if the device is not removed after 6 months. If intestinal migration occurs, surgical or endoscopic removal may be required.
Important: For full safety information please click here, talk with your doctor, or call ReShape Customer Support at 844-YES-RESHAPE.
*Results and patient experience may vary.

Talk with your doctor, or call ReShape Customer Support at 844-YES-RESHAPE (1-844-937-7374).
CAUTION: Rx only.