Currently Viewing:
Evidence-Based Diabetes Management September 2015
What "Behavioral Change" Looks Like From the Front Lines: Visiting Jefferson Hospital
Mary K. Caffrey
Stumbling Toward Access to Evidence-Based Care for the Chronic Disease of Obesity
Theodore K. Kyle, RPh, MBA: and Fatima Cody Stanford, MD, MPH, MPA
Joslin's Hamdy: Evidence Shows Diet, Exercise Effective Against Diabetes, Obesity Long-Term
Andrew Smith
For Now, PBMs Just Say No to High-Cost PCSK9 Inhibitors
Mary K. Caffrey
From Contrave Saga, Renewed Faith in Trials Built on Trust
Andrew Smith
JAMA: High-Dose Liraglutide Causes Significant Weight Loss in Overweight Persons With T2DM
Mary K. Caffrey
Intarcia Says Phase 3 Results Show Better Control Than Januvia for Type 2 Diabetes Mellitus
Mary K. Caffrey
Another Distinct Link Between Cancer and Obesity: the AEG-1 Protein
Surabhi Dangi-Garimella, PhD
Survey Finds Young Patients With Diabetes Getting Fewer Eye Exams Than Older Patients
Mary K. Caffrey
Fingernail Tests May Offer Cheap, Simple Way to Diagnose Diabetes
Mary K. Caffrey
Empagliflozin Is First Diabetes Drug to Hit "Holy Grail" of Cutting Heart Attack, Stroke Deaths in Clinical Trial
Mary K. Caffrey
Food Industry Discusses DGAC Call for Sugar Limits, but Many Are Cutting Back Already
Molly Bourg
If Beef Is Not Sustainable, Is Growing It the Answer?
Molly Bourg
Synjardy Joins Ranks of Combo Therapies for T2DM
Mary K. Caffrey
Currently Reading
Non-Surgical Balloon Device Approved to Treat Obesity
Mary K. Caffrey

Non-Surgical Balloon Device Approved to Treat Obesity

Mary K. Caffrey
Patients being treated for obesity gained a new, nonsurgical treatment option on July 28, 2015, when the FDA approved the ReShape Integrated Dual Balloon System. This device is designed to help adult patients who are obese achieve weight loss without surgery by taking up space in the stomach. In its statement, the FDA said the balloon “may trigger feelings of fullness, or [work] by other mechanisms that are not yet understood.”

The balloon is delivered into the stomach through the mouth via an endoscopic procedure done on an outpatient basis. Patients are mildly sedated, and the process takes about 30 minutes. The balloon is used in combination with a supervised diet and exercise plan to achieve weight loss and maintain it for a short period afterward. Designed to be temporary, the FDA said the balloon should be removed after 6 months.

“For those with obesity, significant weight loss and maintenance of that weight loss often require a combination of solutions, including efforts to improve diet and exercise habits,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “The new balloon device provides doctors and patients with a new nonsurgical option that can be quickly implanted, is nonpermanent, and can be easily removed.”

Approval came after a clinical trial with 326 patients who were obese with a body mass index of 30 to 40 kg/m2 and who had at least 1 other obesity-related condition. In the trial, 187 patients were randomly selected to receive the balloon device; the control group underwent an endoscopic procedure, as well, but did not receive the balloon device. Those with the device lost an average 14.3 lb (6.8% of their body weight) while the control group lost 7.2 lb (3.3% of their body weight). Six months after removal, those treated with the balloon had kept off an average 9.9 lb of the weight they had lost.

Once the device is placed in the stomach, possible adverse effects include head-ache, muscle pain, vomiting, abdominal pain, indigestion, gastric ulcers, and nausea from sedation and the procedure. In rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. The devices should not be used in patients who have previously had bariatric surgery or who have inflammatory bowel disease, large hiatal hernia, symptoms of gastric emptying, are pregnant, or use aspirin daily.
Reference

FDA approves nonsurgical temporary balloon device to treat obesity [press release]. Silver Spring, MD: FDA; July 28, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm. Accessed August 31, 2015.
PDF
 
Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up