Last week, the FDA approved the use of the ReShape Integrated Dual Balloon System — the latest offensive in the battle against obesity in the United States. (Note that about one-third of U.S. adults are now considered obese, meaning they have a body mass index (BMI) of 30% or higher.) ReShape’s latest product offers an alternative to more invasive procedures like gastric banding and gastric bypass surgeries.
Surgery has been recommended for individuals whose BMI exceeds 40% or for individuals with high BMIs who have pre-existing risk factors. But while gastric banding and gastric bypass are efficient, the procedures come with significant risks such as bleeding, infection, inflammation of the esophagus and long-term stomach discomfort. While the ReShape Integrated Dual Balloon System also has risks that include some similar side effects of more invasive surgeries, such as swelling of the esophagus, stomach discomfort, or in more serious cases, rupturing of the device itself, Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health said, as quoted in WebMD: “This new balloon provides doctors and patients with a new non-surgical option that can be quickly implanted, is non permanent, and can be easily removed.”
Dr. Ninh Nguyen, a former president of the American Society for Metabolic and Bariatric Surgery, said that the device “opens up a new opportunity” for patients who would otherwise not qualify for weight loss surgery, according to the AP.
The Dual Balloon device was approved on the heels of promising results from a study of 326 obese people who ranged in age from 22 to 60, according to a study published in WebMD. The study reported that 187 of the 326 participants lost an average of more than 14 pounds, which is equivalent to about 7% of their initial body weight. The device has potential to improve the overall health of the one-third of the U.S. population that is now considered obese, though Dr. Maisel does caution that, “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.”
This new project is emblematic of other efforts to combat American obesity. A recent article in the Washington Times reported The National Institutes for Health has spent $2.6 million since 2011 on a landmark program to help truck drivers lose weight. Run by the Oregon Health and Science University, the program is framed as a weight loss competition. Participants receive health screenings and weight loss tips in addition to motivational phone calls while on the road. According to a January 2014 paper on the study posted by United States Department of Health and Human Services, truck drivers have an obesity rate almost 20%higher than the general public. It claims “driver health problems, especially obesity and related conditions like sleep apnea, are related to driving errors and increased crash rates, impacting both driver safety and the safety of the general public.” During the pilot program, participants lost an average of 7.8 pounds in six months. The program received an additional $2.6 million since 2011, and is budgeted until 2016.
The development and F.D.A. approval of the ReShape Integrated Dual Balloon System sheds light on a much larger issue of public health and increased obesity rates that have been growing since the middle of the last decade. Decreasing obesity rates for good will require a multi-tiered effort from the medical community, academic institutions, and resources for long term re-education regarding maintaining healthier lifestyles.