It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy. Some critics have called it "assisted bulimia" but the device, approved for use in very obese patients, helps them lose on average more than 12 percent of body weight — far more than pills or most Now Playing: Cupcake Crackdown Threatened in Schools Now Playing: What a Newsman, a TV Executive and a Rocker Have in Common Now Playing: Can just a drink a day increase your breast cancer risk? FDA approves first-of-kind device to treat obesity. It is possible that some links will connect you to content only. As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least fda approves new weight loss device and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions. Transcript for FDA Approves New Weight-Loss Device.
Inflated with sterile solution and kept in stomach for no more than 6 months, it makes people feel full This content aapproves not been reviewed within the past year and may not represent Approevs most up-to-date information. To find the most current information, please enter your topic of interest into our search box. WEDNESDAY, July 29, HealthDay News -- Obese Americans struggling to shed pounds have a new weight-loss option: The U.
Food and Drug Administration on Tuesday approved a temporary, implanted balloon device to treat obesity. The ReShape Integrated Dual Balloon System ReShape Dual Balloon works by taking up space in the stomach and causing a feeling of being full. People would typically use the device for no longer than six months, the FDA explained in a news release. Appoves device is placed in the stomach through fda approves new weight loss device mouth during a minimally invasive outpatient procedure using an endoscope.
The procedure typically takes less than 30 minutes and is done while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, the FDA explained in a news release. The device does not change the stomach's natural anatomy, according to the agency. Patients are told to follow a medically supervised diet and exercise fda approves new weight loss device, to help them lose weight while fda approves new weight loss device have the device in their stomach and to maintain weight loss after the device is removed.
William Maisel, acting director, Office of Device Evaluation at the FDA's Center for Dda and Radiological Health, said in the news release. Under the FDA approval, use apprroves the device is limited to obese patients with one or more obesity-related conditions such as high blood pressurehigh cholesterol and diabetes. It's also intended for those who have been unsuccessful in trying to lose weight through weignt and exercise alone, the agency said.
Approval of the ReShape Dual Balloon was based on a study that included obese people, aged 22 to 60, with at least one obesity-related health condition. The participants who used the device lost an average of more than 14 pounds, or 6. Patients who did not receive the device lost about half that amount of weight -- about 3.
Six months after the device was removed, patients had kept off an average of close to 10 pounds of weight wfight lost while the apprives was in place, the FDA said. The device was not without potential side effects. These included some discomfort linked to the alproves needed during the ewight procedure, and "rare cases" of severe allergic reactionheart attackesophageal tear, infection and breathing difficulties, the hew said.
The device-- made by ReShape Medical Inc. Skip to main content. Expert Blogs and Interviews. Taking Meds When Pregnant. Consumer Reports: Best Sunscreens for Can You Be Healthy and Obese? Nuts May Help Colon Cancer Survivors. Can Fidget Spinners Help You Focus? Video: Breaking the Stigma of PTSD. Health Risks of Obesity. Weight Loss Surgery: What to Expect.
Prescription Weight Loss Drugs. FDA Approves 'Belly Balloon' Weight Loss Device. Inflated with sterile solution and kept in stomach for no more than 6 months, it makes people feel full.
AspireAssist: New, Reversible Weight Loss Procedure
Jun 14, · The U.S. Food and Drug Administration today approved a new obesity treatment device FDA ’s Center for Devices device use and weight loss. Jul 29, · FDA Approves 'Belly Balloon ' Weight Loss weight loss after the device is removed. "This new FDA approval, use of the device is. Feb 04, · the first weight loss treatment device that targets the nerve pathway between the FDA approves first-of-kind device to treat New.