Bariatric News: ReShape Integrated Dual BalloonJuly 8, 2015
The ReShape Integrated Dual Balloon System (also known as the ReShape Dual Balloon) is an exciting new development in the treatment of obesity. The ReShape Dual Balloon takes up space in the stomach to help patients limit portion sizes and feel full. Patients that are candidates for the ReShape Dual Balloon will have a BMI between 30 and 40 with at least one obesity-related co-morbidity. The ReShape Dual Balloon is indicated for use in adult patients. Initially, the ReShape Dual Balloon will be a cash pay procedure.
Bariatric surgeons who have the necessary endoscopic skills can place the ReShape Dual Balloon. Physicians who have the skills and are staffed to handle the patient aftercare and monthly counseling sessions will be best equipped to integrate this new treatment option.
"I am enthusiastic with the availability of the dual intragastric balloon for the treatment of patients with moderate obesity that have exhausted non-surgical weight loss options and still are not candidates or are not interested in surgery. The design of this balloon allows for better patient tolerance and safety decreasing the risk of migration. Will be a great tool coupled with a good weight loss program and exercise.”
~ Dr. Jaime Ponce
Placement of the ReShape Dual Balloon
The ReShape Integrated Dual Balloon System is placed endoscopically during a 20 minute outpatient procedure. Patients first receive conscious sedation (light anesthesia) to relax them and make them comfortable, then the doctor places an endoscope into the mouth and advances it through the esophagus and into the stomach. The doctor inspects the stomach to make sure there are no conditions that would prevent placement of the balloon. The uninflated ReShape Dual Balloon device is inserted into the mouth and advanced through the esophagus and into the stomach. Each balloon is filled with a saline solution that contains a small amount of blue dye. Once both balloons are filled and the endoscope is removed, the patient is moved to the recovery area and is usually able to go home within an hour.
After the procedure, it is recommended that patients take the next few days off from work while the stomach adjusts to the balloon. Most patients’ symptoms resolve within the first week and they are able to return to their normal routine.
Lifestyle with the ReShape Dual Balloon
Following placement of the ReShape Dual Balloon, patients will gradually progress from a liquid diet, to a soft diet, to enjoying a normal diet. Once patients transition back to a normal diet, patients are not limited in the types of foods they can enjoy. Patients will have regular follow up with a dietitian to receive guidance on healthy diet choices, correct portions and total calories.
Removal and contraindications of the ReShape Dual Balloon
The ReShape Dual Balloon is removed endoscopically (through the mouth) during a short, 20 minute outpatient procedure performed under conscious sedation (light anesthesia). The use of sequential balloon placement was not studied in the U. S. REDUCE pivotal FDA trial. Physicians outside of the U.S. do sometimes incorporate use of sequential intragastric balloon placement in their treatment plan. The ReShape Dual Balloon would not be a treatment for patients who have had prior weight loss surgery, and contraindicated for patients with a large hiatal hernia, intractable gastric reflux, stomach ulcers or GI strictures.
FDA approval and results of the ReShape Dual Balloon
The PMA was submitted in June, 2014, and is currently under review by the FDA.
*UPDATE* On July 28th, the FDA's approval was announced, and now is an option for people struggling with obesity.
"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, in a news release. "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."
The results of the ReShape Dual Balloon in Europe have been excellent. Dr. Lopez-Nava from Madrid, Spain recently published his ReShape Dual Balloon results and reported 47% EWL at 6 months, a very low early retrieval rate (< 2%) and a good safety profile.
The primary risk with any intragastric balloon is the possibility that the balloon migrates from the stomach into the intestine and causes an obstruction. The ReShape Dual Balloon design helps mitigate this risk by having two independent balloons attached to a central shaft. If one balloon deflates, the second balloon prevents the device from migrating into the intestines.
The ReShape Dual Balloon is made of silicone, which is a material with excellent biocompatibility properties. There were no reported adverse reactions to the silicone material in the REDUCE trial. There have been no adverse or allergic reactions from the ReShape Dual Balloon material. Some patients do request early removal of the balloon due to either the severity or duration of symptoms such as nausea, vomiting or abdominal pain.
Additional healthcare provider information
- There is a five times larger addressable patient population in the 30-40 BMI vs. 40 and over BMI (35.7% of Americans are BMI 30-40 and only 6.3% are BMI 40 plus):
- The ReShape Procedure offers a new treatment option that will help an entirely NEW patient population.
- In the REDUCE trial, 75% of patients said they would recommend the treatment to a friend.
- Key benefits of the ReShape Integrated Dual Balloon System:
- SATIETY - With the capacity to hold up to 900 cc of saline, the ReShape Dual Balloon offers more gastric filling than any single balloon device.
- COMFORT - Mimicking the natural curvature of the stomach, the dual balloon is designed to conform to the patient’s anatomy and enhance tolerability.
- SAFETY - In the unlikely event of individual balloon leakage or deflation, the independently sealed balloons are designed to minimize risk of migration or obstruction.
This video will show the placement and removal of the ReShape Integrated Dual Balloon System:
The results reported by four ReShape Dual Balloon patients are a sample from the patient population that have had the procedure:
“After ReShape, my life changed so much, and all for the better. I lost 35 pounds and five dress sizes, and I gained a new healthy lifestyle. I have more energy, I feel more confident, and I know my family is so proud of me!” –Kellie
“I had tried every diet known to man, but I would always get hungry and frustrated and quit. With ReShape it was different. I never felt hungry and that helped me make healthier food choices. I liked that I didn’t have to have surgery. As the weight came off, I was more motivated than ever to stick with it.” –Michelle
“ReShape just made sense. The balloons take up the room in your stomach, so you can’t eat as much. After the first few days, I couldn’t feel them at all. I just wasn’t hungry anymore.” –Patrick
“I had a very positive experience with ReShape. I lost a lot of weight that I don’t believe I could have ever lost without the procedure. The tools and coaching I received went hand in hand with the balloons and helped me be successful.” –Carmelia
Photo credit: ReShape Medical
Video credit: ReShape Integrated Dual Balloon System YouTube Channel
ABOUT THE AUTHORJaime Ponce, MD, FACS, FASMBS, is a board certified Bariatric Surgeon in private practice at Chattanooga Bariatrics PLLC. He is the Medical Director for Hamilton Medical Center Bariatric Surgery program in Dalton Georgia and Co-Director for Memorial Hospital Bariatric Surgery program in Chattanooga Tennessee. Dr. Ponce has served as President (2012-2013) of the American Society for Metabolic and Bariatric Surgery (ASMBS) and President of the International Federation for Surgery of Obesity (IFSO) North American Chapter (2013-2014).