by Robert Preidt
. Health reporter
Medicine For Belly Fat Loss - FDA Approves 'Belly Balloon' Device for Weight Loss
Wednesday, (Healthday News) - American obese fighting for pounds have a new weight loss option: US Food and Drug Administration on Tuesday Approved, a temporary deployed balloon device to obesity delight
Double Remodeling Balloon Integrated System (double balloon remodel) works through stomach space and causing a feeling of being full. People usually use the device for a maximum period of six months, the FDA explained in a statement.
The device is placed in the stomach through the mouth during a minimally invasive outpatient procedure using an endoscope. The process usually takes less than 30 minutes and is done while the patient is under light sedation.
Once in place, the balloon device is inflated with a sterile solution, the FDA explained in a statement.
The device does not change the natural anatomy of the stomach, according to the agency. Patients are instructed to follow a diet and plan exercise under medical supervision to help them lose weight while they have the device on your stomach and keep weight loss after the device is removed.
"This new balloon device provides doctors and patients with a new non-surgical option that can be quickly deployed, is non-permanent, and can be easily removed," Dr. William Maisel, director in the exercise of the device office Evaluation in FDA Center for devices and radiological health, said in a press release.
According to FDA approval, the use of the device is limited to obese patients with one or more obesity-related conditions, such as high blood pressure, high cholesterol and diabetes levels. It is also intended for those who have not succeeded in attempting weight through diet and exercise alone, told the agency.
"For those with obesity, significant weight loss and maintenance that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits," said Maelel.
The approval of the double balloon remodel was based on a study that included 326 obese people, aged 22 to 60, with at least one obesity-related health condition. The 187 participants who used the device lost an average of more than 14 pounds, or 6.8 percent of their total body weight at the time the device has been removed.
Patients who did not receive the lost device about half of this amount of weight - about 3.3 percent of their total body weight, the FDA
said.Six months after the device was removed, the patients had kept an average of about 10 pounds of lost weight, while the device was in place, the FDA said.
The device has not been without side effects. These included some discomfort linked to the sedation required during the insertion procedure, and "rare cases" of severe allergic reaction, heart attack, esophageal tear, infection and respiratory difficulties, the agency said.
"Once the device is placed in the stomach, patients may feel vomiting, nausea, abdominal pain, gastric ulcers and feelings of indigestion," added the FDA.
Device-- Made by Remodel Medical Inc., California - should not be used in people who have had gastrointestinal or weight loss previous surgeries; have been diagnosed with inflammatory intestinal disease or intestine, large hiatal hernia, symptoms of retarded gastric emptying or active H. pylori infection; pregnant women; Or people who use aspirin a day, the FDA said.
