Uses: ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is a balloon device to facilitate weight loss in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2.
Delivery: The device works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood. It is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. Once in place, the balloon device is inflated with a sterile solution.
More Information: The approval was based on a clinical study involving 326 obese participants aged 22 to 60 years who had at least 1 obesity-related health condition. In the study, 187 individuals randomly selected to receive the device lost an average of 14 lbs. when the device was removed at 6 months while the control group lost an average of 7 lbs.
Side Effects/Risks: Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and indigestion. The device should not be used in patients who have had previous gastrointestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H. Pylori infection, those who are pregnant or use aspirin daily.
Source: FDA web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455103.htm. Updated July 16, 2015. Accessed August 3, 2015.
This Week's Must Reads
Relevance of Health Literacy to CV Health, Circulation; ePub 2018 Jun 4; Magnani, et al
Diabetes & Long-Term Kidney Disease, Diabetes Care; ePub 2018 Jun 1; Warren, et al
Maternal Loss of Control Over Eating, Am J Clin Nutr; ePub 2018 Jun 5; Micali, et al
Efficacy of Brief Behavioral Treatment for Insomnia, Sleep Medicine; ePub 2018 Jun 2; McCrae, et al
Opioid-Related Adverse Events in Surgical Patients, JAMA Surg; ePub 2018 May 23; Shafi, et al
Must Reads in Obesity
Sleep Insufficiency’s Role in Childhood Obesity, Sleep Medicine; ePub 2018 Apr 5; Arora, et al
Impact of Intensive Weight Loss & Life Expectancy, Diabetes Care; ePub 2018 Mar 15; Gregg, et al
Obesity Progression and Incident Diabetes, Diabetes Care; ePub 2018 Mar 5; Stokes, et al
Association of BMI with Lifetime Risk of CVD, JAMA Cardiol; ePub 2018 Feb 28; Khan, et al
Effect of Low-Fat vs Low-Carb Diet on Weight Loss, JAMA; 2018 Feb 20; Gardner, et al