FDA Approval of ReShape™ Dual Balloon Marks Significant Step for the Weight Loss Program in Helping at Risk Group of Patients


Obesity is on the rise and is a worldwide epidemic. A recent Lancet study noted that the chance of an obese person becoming normal weight is less than .5%.  Currently in the United States, the obese population outnumbers the overweight population. Bariatric surgery helps patients with severe obesity in terms of weight loss, reduction in severity and number of comorbid conditions. This week the U.S. Food and Drug Administration approved the ReShape™ Integrated Dual Balloon System (ReShape™ Dual Balloon) to treat obesity without the need for invasive surgery.

“There are few treatments available for obese patients and the FDA approval of the ReShape™ Dual Balloon significantly increases the armamentarium of weight loss programs in helping this at risk group of patients,” said Dr. Marina Kurian, Chair of SAGES Endoscopic Bariatric Task Force and Bariatric Surgeon at New York University Langone Medical Center.

Intragastric balloons are a non-surgical treatment option for patients, different than current therapies, but should be offered in a comprehensive bariatric care center to promote the best outcomes.  In an outpatient setting, interventional endoscopists will be able to place this non-surgical device. Many patients may receive this as a primary treatment for obesity and others may use this temporarily as a bridge to safer laparoscopic surgery. The success of the gastric balloon is impacted by patient follow up and dietary guidance. The intragastric balloon is a six month intervention at which point it is removed. Patients remain in a structured dietary program for a year so that weight lost is maintained. The balloon has been approved for patients with a body mass index (BMI) of 30 to 40 with unsuccessful attempts at weight loss and should be placed for obese patients enrolled in a structured weight loss program.

According to Dr. Matthew Kroh, co-chair of SAGES Endoscopic Bariatric Task Force and Director of Surgical Endoscopy at the Cleveland Clinic, “The introduction of intragastric balloon therapy for Americans will allow patients access to a minimally invasive non-surgical approach to treat obesity and weight related disease. Overall, the FDA approval of the balloon is an important aid in the battle to stem the tide of obesity.”

For more information on the FDA approval and on the ReShape™ Dual Balloon visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm or http://reshapeready.com/

SAGES has been at the forefront of best practices in endoscopic and laparoscopic surgery by researching, developing and disseminating the guidelines and training for standards of practice in surgical procedures. SAGES Guidelines for Clinical Application of Laparoscopic Bariatric Surgery, were issued in 2008 and are a series of systematically developed statements to assist physicians’ and patients’ decisions about the appropriate use of laparoscopic surgery for obesity. Guidelines are available at http://www.sages.org/publications/guidelines/guidelines-for-clinical-application-of-laparoscopic-bariatric-surgery.