The epidemic of obesity is now fully upon us, with almost 7 out of 10 adults considered to be overweight or obese, with over 1 out of 3 adults of adults considered to be obese and, more than 1 out of 20 adults considered to have extreme obesity, with women with extreme obesity outnumbering men, 2:1.
With this in mind, I would like to discuss my involvement with the ReShape™ Integrated Dual-Balloon, endoscopic gastric balloon placement in conjunction with a carefully monitored 12-month lifestyle modification and weight loss program.
This non-surgical weight loss procedure, which received FDA approval on July 28th, 2015 is designed to offer an unmet need for obese patients with a BMI of 30-40. It is not intended to compete with or replace bariatric surgery. This program “jump-starts” the patient’s weight loss, by endoscopic placement into the lumen of the stomach of a uniquely designed, dual gastric balloon. For most patients, the procedure takes less than 20 minutes, and no hospital stay is required.
Before approval by the FDA, a clinical study of 326 patients was conducted at eight sites across the United States. Patients with ReShape™ experienced 2.3 times more excess weight loss (EWL) at six months (28%EWL) compared to those who followed the diet and exercise program alone (12%EWL). In the clinical trial, patients lost up to 72 pounds in 12 months. Six months after the balloon was removed, on average two-thirds of the weight loss obtained during the balloon phase was maintained, and 25% of patients continued to lose weight. 55% of patients treated with the ReShape™ Procedure lost 25% of their excess weight. In a European Study where patients had to pay for the costs of the ReShape™ Program, the results were even better. The average total body weight loss was 37.62 lbs, the average percentage body weight loss was 16%, and the mean percentage excess weight loss was 48.8%
To achieve optimal results for the patient, ReShape™ has been extremely cautious about the introduction of this reversible endoscopic procedure and I am proud that after due diligence on both sides, my practice after being chosen by ReShape™ as one of just a few centers in Northern California, agreed to offer selected patients, this particular type of endoscopic gastric balloon placement.
Suitable patients are those who suffer from obesity with a BMI between 30-40 ( a BMI not high enough to qualify bariatric surgery) who have not been able to lose weight or maintain weight loss after previous attempts at dieting and have an obesity-related comorbidity, such as gastroesophageal reflux disease (GERD), non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), metabolic syndrome, type 2 diabetes mellitus (DM2), hypertension, dyslipidemia obstructive sleep apnea and/or for psychosocial reasons.
The ReShape™ program “jump-starts” your weight loss, by endoscopic placement into the lumen of the stomach of a uniquely designed, dual gastric balloon. The two balloons are connected to each other by a flexible shaft and remain inflated in the stomach for six months, after which time they are removed. Compared to the single gastric balloon, the design of the dual balloon better conforms to the stomach’s anatomy and allows greater patient comfort. It also reduces the risk of a deflated balloon migrating from the gastric lumen into the intestine, where it could otherwise cause a bowel obstruction because the other inflated balloon will remain in-situ and will prevent the above from happening. For most patients, the procedure takes less than 20 minutes, and no hospital stay is required.
After the balloons are positioned in the stomach, they are filled with saline which causes the stomach to become about 75% full. This reduces your hunger, so you feel satisfied with smaller portions of food. By curbing your appetite, the dual balloon helps your brain to learn about portion size and to lose weight.
For six months following placement of the dual balloon and then for a further six months after its removal, you will receive frequent in-office life-style modification coaching sessions ( per the 2000, NHLBI Guidelines), by ______________ which will include healthy eating and exercise habits that will continue to be part of your daily routine beyond the treatment period. I have worked with ______ for over almost 00 years and because of her/his expertise she/he will be a wonderful resource for you.
The cost of the ReShape™ Integrated Dual-Balloon Weight Loss Program includes:
Since ReShape™ is a relatively new procedure here in the US it is currently not covered by insurance. However, my office can put your patient in touch with companies that offer financing options that can make the program affordable. You may also be able to use a tax-free Health Savings Account
Proven Weight Loss Without Surgery: In the FDA study, patients lost more than twice as much weight with ReShape™ than with diet and exercise alone – and most patients keep the weight off or continue to lose, even after the balloons are removed.