Commentary by John Morton, MD, MPH and William Maisel, MD, MPH
A new balloon device to treat obesity without the need for invasive surgery was approved by the U.S. Food and Drug Administration (FDA). The ReShape Integrated Dual Balloon System (Figure 1) works by occupying space in the stomach, which limits the space for food intake and triggers feelings of fullness.
The ReShape Dual Balloon is indicated for weight reduction in adults with a BMI of 30 to 40 kg/m2 and 1 or more obesity-related conditions, such as high blood pressure, high cholesterol, and diabetes. It is intended for patients who have failed previous attempts at weight loss through healthy eating and physical activity alone.
“Many Americans who face the risk and consequences of obesity have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range,” said John Morton, MD, MPH, President of the American Society for Metabolic and Bariatric Surgery. “Options like ReShape address a significant gap that exists between diet and exercise, weight loss medications, and surgery, offering a minimally invasive, reversible option which we hope will promote long-term healthy habits.”
ReShape is Inserted Endoscopically
The device is inserted into the stomach endoscopically and is filled with saline. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation.
The device does not change or alter the natural anatomy of the intestinal tract, remains in the stomach for 6 months, and then is drained and removed endoscopically. Patients are advised to follow a medically supervised meal plan and increase their physical activity to augment their weight loss efforts while using the ReShape Dual Balloon, and to maintain their weight loss following its removal.
“For those with obesity, significant weight loss, and maintenance of that weight loss, often requires 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. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”
Clinical Findings on the ReShape Device
The ReShape Dual Balloon was studied in a prospective, randomized controlled trial involving 326 people aged 22 to 60 years with a BMI of 30 kg/m2 to 40 kg/m2 who had at least 1 obesity-related health condition.
In an intent-to-treat analysis, patients randomized to the device (n=187) had a significantly greater percent of excess weight loss at 6 months compared to patients who received a sham control that underwent an endoscopic procedure but were not given the device (n=139; 25.1% vs 11.3%; P=0.004). Among patients who completed the trial, participants who received the ReShape Dual Balloon (n=167) lost 15.9 pounds on average (7.6% of their total body weight) when the device was removed at 6 months, while the control group (n=126) lost an average of 7.8 pounds (3.6% of their total body weight), as reported in the REDUCE trial published in the July-August issue of Surgery for Obesity and Related Diseases.
Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost, according to an FDA press release.
Adverse Events Reported in the REDUCE Trial
In the REDUCE trial, 34.1% of patients treated with the ReShape device experienced nausea and vomiting on day 3, and 11.6% experienced abdominal pain; these side effects typically resolved over time with 6% and 1.2% experiencing the respective side effects at 24 weeks. Gastric ulceration occurred in 35% of patients, and were inconsequential and discovered during routine device retrieval in all but 1 case.
The following adverse events of note occurred: esophageal mucosal tear during retrieval requiring placement of hemostatic clips (n=1), gastroesophageal junction ulcer-associated gastrointestinal hemorrhage requiring transfusion (n=1), contained cervical esophageal perforation during retrieval requiring IV antibiotic treatment (n=1), and postretrieval pneumonitis requiring antibiotic treatment (n=1). In addition, 3% of patients in whom device insertion was attempted experienced 1 or more dual nonaccommodative device- or procedure- related serious adverse events. No deaths, intestinal obstructions, gastric perforations, or device migrations were observed during the trial.
This device is contraindicated in patients who have:
In addition, patients who are pregnant, use aspirin daily, or are unable or unwilling to take proton pump inhibitor therapy while the device is in place, should not receive the device. Furthermore, patients with a history of peptic ulcer associated with H. pylori should be tested for this infection and treated prior to balloon insertion, according to the ReShape instructions for use.
The ReShape Dual Balloon is manufactured by ReShape Medical Inc., in San Clemente, California.
U.S. Food and Drug Administration. FDA News Release: FDA approves non-surgical temporary balloon device to treat obesity. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm. Accessed August 26, 2015.
ReShape Medical. FDA approves the reshape integrated dual balloon system, a first-of-its-kind non-surgical weight loss procedure for people with mild to moderate obesity. http://www.multivu.com/players/English/7419551-reshape-medical-fda-approval/. Accessed August 26, 2015.
ReShape Medical. ReShape Integrated Dual Balloon System Instructions for Use. http://reshapeready.com/wp-content/uploads/2015/07/ReShape_Instructions_For_Use.pdf. Accessed August 26, 2015.
Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874-881.