The manufacturer of this weight loss device, which could be available as early as next year pending Food and Drug Administration approval, hopes to lure obese individuals who do not want to undergo weight loss surgery or cannot do so safely to slim down by moving, eating less and exercising. The ReShape Duo balloon works similar to that of gastric banding, where a band is placed in the upper stomach to limit the amount of food consumed.
The balloon is placed into the stomach of a patient with an endoscope. From there, it is inflated with saline that helps make the patient feel full after a modest calorie intake. There are no incisions or stitches needed with this outpatient surgical procedure. The procedure total takes about 20 minutes. Most patients complain of nausea as the common side effects that can last for a few days. Six months later, the balloon is removed with the same endoscopic surgical procedure.
In the study, 326 obese patients were evaluated in two different groups. The first received the balloon while the others underwent a sham endoscopic procedure. Patients in both groups participated in nutrition and exercised counseling throughout the study and for six months after.
It’s important to note that this study is ongoing and the device’s manufacturer, ReShape Medical, will not and cannot release data. However, President and CEO Rick Thompson said that patients who had the balloon installed achieved a significantly greater percentage of weight loss than those in the sham group. In many instances, patients lost 25% or more of their excess weight.
According to the results of an earlier and smaller study, two-thirds kept weight off or continued to lose weight, which shows benefits to the device and how it can outlast ordinary jumpstart weight loss. Based on these results, the company expects a U.S. launch of the product in mid to late 2015.
The study’s researchers believe that even a 5% weight loss can have a significant effect on a patient’s overall health. However 25% or more rates are impressive and not uncommon with the balloon and those studied. This type of balloon is designed in such a way to reduce migration risk that can happen when a balloon deflates and moves to the intestines, which causes a blockage. If this happens, the dye will be visible in the urine, which eliminates the risk of not knowing when a potential risk has occurred.
Many doctors including Dr. Stanley Rogers, chief of minimally invasive surgery and director of the bariatric surgery center at UCSF believe that the stomach balloons will play a role in patients needed to lose weight before surgeries such as gastric bypass. It also provides a safer weight loss route for those with many co-morbidities who are not candidates for the surgery. The surgery may also be an excellent option for those who need to lose weight before joint replacement surgeries such as the knee or the hip. Their weight loss will help to reduce their risk of complication following surgery.