The U.S. Food and Drug Administration 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 system was developed by ReShape Medical, a medical device manufacturer headquartered in Southern California.
"Many Americans have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range. 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," said John Morton, MD, MPH, President of the American Society for Metabolic and Bariatric Surgery.
The ReShape Dual Balloon is inserted in the stomach through an endoscopic procedure and filled with 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.
The ReShape Integrated Dual Balloon System also underwent rigorous testing and academic studies. A study has found that patients who had the ReShape Procedure lost 2 times as much weight as a group who only received diet and exercise coaching.
The new invention has also earned praise from patients who've attended 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. 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," said Carmelia, a ReShape patient.