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.