A new obesity procedure could offer a safe alternative to invasive surgery options. Doctor-implanted balloons placed within the stomach can help to trigger extreme weight loss without the new for bariatric surgery. According to this new clinical trial, the new device (two connected balloons with saline) helped obese individuals lose twice as much weight as those who relied on diet and exercise.
ReShape Duo is made by ReShape Medical Inc. who sponsored the clinical trial. According to the principal investigator, Dr. Jaime Ponce and presenter of these findings at the annual meeting of the Obesity Society, the device has seen optimistic preliminary findings. Ponce is the medical director of the bariatric surgery program at Hamilton Medical Center and also is a paid consultant for the company that manufactures the weight loss device.
About the Device
This new balloon, ReShape Duo, will help reduce the size of the stomach making individuals feel full faster. Those with balloons lost nearly 28.5% of their excess weight in just six months compared to just 11.3 percent weight loss for those who just changed their lifestyle.
Doctors insert the balloons through a scope that goes down the throat and directly into the stomach. The balloons are then filled with saline with a blue dye. This takes about 8 minutes to place the balloons and only 14 minutes to remove them if needed.
Two connected balloons are used because earlier trial of single balloons had them dislodging or migrating toward the digestive tract. This can block the bowels, according to Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York City.
If one of the balloons rupture, the other balloon will stay inside of the stomach, Ponce says. The patient’s urine will turn blue which will alert them of the rupture so they can go back in and remove the entire device before serious complications occur. This only happened in about 6% of all trial patients and no bowel migration occurred in those patients either.
The trial itself included 326 patients who had a body mass index (BMI) of 30 to 40. Each of these patients was randomly assigned to a sham endoscopic procedure or a balloon procedure. Patients in both of these groups were required to participate in a diet and exercise counseling program for the duration of the study and for six months after.
Ponce said that the balloons fill a therapeutic gap for those who need to lose weight quickly, but don’t want to endure the invasiveness of surgery or don’t qualify at all.
This new non-surgical therapy allows patients to treat their obesity in a safer and less invasive way.
These temporary weight loss devices can help patients’ jumpstart their weight loss. Some people need to slim down quickly for cancer treatment or cardiac surgery, but can’t have weight loss surgery because of their size and how unsafe going under may be for them. These patients are the best options for these weight loss balloons.
Many weight loss experts question how permanent the weight loss actually can be. The balloons themselves have to be removed after six months in order to reduce the risk for rupture and the development of stomach ulcers from the friction of the balloon. In the trial, researchers found that gastric ulcers occurred in about 35% of all patients.
Nearly 15% of patients in the trial had the device removed permanently due to intolerance whether from discomfort or nausea. Many patients do adapt, but many have the balloons removed entirely.
The U.S. Food and Drug Administration are determining whether they will approve this device in the United States. The device itself has been available in Europe since 2011 and costs about $6,200 USD.