It is predicted that by 2030 a whopping 42 percent of Americans will be obese – a nearly 20 percent increase from just six years ago.
Unfortunately, this doesn’t come as a surprise given that the number of obese adults has more than doubled in the last two decades. Yet, little progress has been made in the last 20 years to find non-invasive treatment options that effectively complement sensible eating habits and physical activity; especially for those who fall into the mild to moderate range, or 30-40 Body Mass Index (BMI).
While the goal of achieving desired and sustainable weight loss is there, this class of patients may not even consider themselves obese and therefore they continue to struggle without considering medical intervention.
Primary care physicians routinely see patients who fall into this mild to moderate category. Most of these patients fail to lose weight or continue to gain weight despite their best efforts with diet and exercise. Bariatric surgery is usually not considered for patients in the 30-35 BMI range, but we know a lower BMI doesn’t always equal more success with traditional weight loss methods or medication. As a bariatric surgeon, I know firsthand how life changing weight loss surgery can be for many who suffer from obesity. That said, in some cases surgery is simply not a viable option.
Enter the gastric balloon: a truly new class of treatment for patients who find themselves in the middle of the obesity spectrum. Gastric balloons, proven highly safe and effective in clinical trials, and now FDA approved, can serve as a jumpstart to weight loss.
The first gastric balloon to be approved last year is a dual balloon. This new treatment option is eligible for patients with a Body Mass Index (BMI) of 30-40, considered to be mild to moderately obese. Made of silicone and connected by a flexible shaft; the balloon is inserted into the patient’s stomach during a 20 minute outpatient procedure. An endoscope is inserted through the mouth into the stomach and the un-inflated balloon is advanced over a guide wire and precisely placed in the stomach where it is inflated with sterile saline and a small amount of methylene blue dye. The dual balloon design creates the feeling of fullness, contours comfortably in the stomach and provides a safety net—if one balloon should accidentally deflate, the other prevents it from migrating to the intestines. The blue dye then shows up in the patient’s urine to alert them.
Once the balloon is implanted the patient receives comprehensive counseling and support services that include frequent in-office coaching sessions to encourage new habits and lasting results. Allied health professionals at the bariatric surgeon’s office are able to monitor the patient’s weight loss via a patient portal. The combination of the balloon and the one-on-one customized counseling is the real key to the patient’s success. The dual balloon is removed after six months and coaching continues for an additional six months.
Prior to FDA approval in the United States, the dual balloon has been available in Europe since 2011 and has shown clinically significant weight loss. In the U.S. Pivotal trial the dual balloon demonstrated that patients who underwent the procedure experienced 28 percent excess weight loss (EWL) which is 2.3 times more than the group treated with diet and exercise alone who only experienced 12 percent EWL. The improvements were clear in terms of patient satisfaction and maintenance as well. Study patients were able to sustain an average two-thirds of the initial weight lost at their 12 month follow up. In addition, 78 percent of trial patients said they would recommend the dual balloon procedure to a friend.
Today more than 60 million Americans are believed to be within the BMI range of 30-40. The lack of safe and effective treatment options available for this subset of obese patients has been a source of frustration for many primary care physicians and bariatric surgeons alike. In my opinion, the advent of the gastric balloon presents a significant improvement for this widespread, challenging disease and one that should be considered as a potential intervention for those patients who have struggled for far too long with limited options.
By Thomas Lavin, MD
Tom Lavin, MD, FACS, FASMBS founded The Surgical Specialists of Louisiana in 2000 with locations now including Covington, New Orleans, Slidell, and Lafayette. Dr. Lavin is an ASMBS (American Society for Metabolic and Bariatric Surgery) Center of Excellence Bariatric Surgeon and has been a pioneer in developing and promoting incisionless and minimally invasive weight loss procedures. For more information, please visit http://www.whyweight.com/.