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
No Need to Alter TKI Treatment in These Patients, Am J Hematol; ePub 2017 Oct 13; Alhuraiji, et al
Insurance Subsidy Impact on New TKI Users Assessed, Cancer; ePub 2017 Oct 4; Shen, Zhao, Liu, et al
Ruxolitinib in Patients Who Can’t Take Hydroxyurea, Blood; 2017 Oct 12; Verstovsek, Passamonti, et al
Socioeconomic Status Impact on Chronic GVHD, Biol Blood Marrow Transplant; ePub 2017 Oct 12; Hamilton, et al
Impact of Precision-Dosing Strategy with IVIG, Pharmacotherapy; ePub 2017 Oct 13; Stump, et al
Must Reads in Obesity
Metabolic Outcomes After Gastric Bypass Surgery, N Engl J Med; 2017 Sep 21; Adams, et al
Weight Gain & Odds of Healthy Aging, JAMA; 2017 Jul 18; Zheng, Manson, et al
Improved Diet Quality & Mortality Risks, N Engl J Med; 2017 Jul 13; Sotos-Prieto, et al
New Dietary Guidelines for Americans, DHHS/USDA guidelines target chronic diseases
Excess Sodium Intake in the US, Study looks at prevalence and risks