"The U.S. Food and Drug Administrations approval of a temporary implanted balloon device for weight loss may have many wondering how  and how well  it works. Called the ReShape Integrated Dual Balloon System the device consists of two connected balloons filled with saline. The balloons take up space in the stomach which presumably makes people feel fuller faster the FDA said in its announcement Tuesday. But the device can only be used for six months at a time and it is not likely to be an alternative for people who require lapband surgery stomach stapling or other forms of bariatric surgery said Dr. Mitchell Roslin chief of obesity surgery for Lenox Hill Hospital in New York City. Its going to be effective for shortterm weightloss Roslin said but there is still an overwhelming question whether these devices provide any longterm benefit for obesity. I dont think its going to be part of the medical algorithm for treating obesity he added. I think its going to be for people who want to lose weight fairly rapidly. In a clinical trial the ReShape system helped people more than double their weight loss compared to those trying to lose weight through diet and exercise an FDA news release said. That clinical trial was funded by the company that makes the ReShape system according to a presentation from the Obesity Society annual meeting in Boston. The device is available to obese people who often dont qualify for surgical weightloss procedures according to the FDA. Obese people who have a bodymass index a rough estimate of body fat based on your height and weight between  and  and at least one obesityrelated health condition are eligible for the new procedure the agency said. Obesityrelated health conditions include high blood pressure type  diabetes and high cholesterol. Its also intended for those who have been unsuccessful in trying to lose weight through diet and exercise alone the agency said. Doctors insert the balloons through a scope snaked down the throat and into the stomach and then fill them with saline containing a blue dye. It takes about eight minutes to place the balloons and about  minutes to remove them according to Dr. Jaime Ponce medical director of the bariatric surgery program at Hamilton Medical Center in Dalton Ga. Ponce was the principal investigator of the clinical trial on the ReShape system. The device doesnt change the stomachs natural anatomy according to the FDA. Patients are told to follow a medically supervised diet and exercise plan to help them lose weight while they have the device in their stomach and to maintain weight loss after the device is removed. A pair of connected balloons are used because earlier singleballoon versions tended to dislodge and migrate down the digestive tract blocking the bowels Roslin explained. With ReShape if one of the balloons ruptures then the other balloon will keep it in the stomach. The blue dye that filled the balloon will turn a patients urine blue letting the person know that one of the balloons has ruptured. Doctors can then go back in and retrieve the entire device. Nausea is a common side effect of the device. In the clinical trial about  percent of patients had to have the balloons removed prematurely due to intolerable nausea according to Ponce. The first few days are associated with a fair amount of nausea and you will need some coaching to get through that Roslin said. Another troubling side effect is gastric ulcers caused by the balloons rubbing against the stomach wall. About  percent of patients in the clinical trial suffered ulcers but researchers said most of the ulcers were small and superficial. Roslin also believes that for now patients will have to pay cash for the ReShape. It is not going to be reimbursed by insurance at least for the first generation and certainly for the foreseeable future he said. The balloons have been available in Europe since  where their average price is about  according to the manufacturer ReShape Medical Inc. in California. The people who initially will use the ReShape are people who can afford to pay for it outofpocket and need to drop some pounds quickly Roslin said. In the clinical trial the  participants who used the device lost an average of more than  pounds or about  percent of their total body weight. Patients who did not receive the device lost about half that amount of weight  just over  percent of their total body weight the FDA said. More information For more information on how being overweight or obese affects your health visit the National Institute of Diabetes and Digestive and Kidney Diseases http SOURCE Mitchell Roslin M.D. chief obesity surgery Lenox Hill Hospital New York City  Jaime Ponce M.D. F.A.C.S. medical director bariatric surgery program Hamilton Medical Center Dalton Ga. Nov.   presentation Obesity Society annual meeting Boston Mass. U.S. Food and Drug Administration news release July"