Among the major comorbidities associated with obesity is type 2 diabetes, a progressive disease that significantly affects health and quality of life in patients, leading to high medical costs and loss of productivity. A recent study in the American Journal of Preventive Medicine revealed that while only 2 out of every 1,000 normal-weight people had diabetes, 18.3 out of every 1,000 obese people have the disease. A newly FDA-approved non-surgical weight loss device, however, may help obese people with diabetes lose weight and improve their diabetes symptoms in the process.
The American Society for Metabolic and Bariatric Surgery (ASMBS) recently announced that the U.S. Food and Drug Administration (FDA) approved a new intragastric balloon device for individuals with obesity and obesity-related conditions – the ReShape Integrated Dual Balloon System. The device is indicated specifically for obese adults with a body mass index of 30 to 40 kg/m2 with one or more obesity-related conditions such as diabetes who have failed to lose weight through diet and exercise alone. ASMBS believes that this device may help overcome the lack of therapies between medication and surgery in this patient population.
“I am pleased and gratified that after careful review the FDA has approved this new device for the treatment of patients with obesity or body mass index (BMI) of 30 to 40. We are at the dawn of a new age in obesity treatment with the addition of this safe and effective treatment option,” said the President of the ASMBS Dr. John M. Morton in the press release. “Much like cardiac disease, we are seeing demonstration of the full continuum of care for obesity from primary prevention and FDA-approved medications to the endoscopic ReShape Dual Balloon to established, effective bariatric surgery procedures. The ReShape Dual Balloon offers a bridge between medications and surgery similar to a cardiac stent in cardiac disease.”
The ReShape Dual Balloon is a non-surgical weight loss procedure, where a dual balloon is delivered into the patient’s stomach through the mouth via a minimally invasive endoscopic procedure. The balloon is then inflated fitting the natural shape of the stomach, minimizing discomfort, and helping the patient feel full, therefore leading to a decreased food intake and subsequent weight loss. The dual balloon has a greater total volume than typical single balloons.
“In the right patients and in the right hands, this new device will provide hope to patients who may not have sought care before this approval. Like any other obesity intervention, the results of this intervention must be enhanced and safeguarded within a proven, multi-disciplinary program that provides the critical support to ensure success,” noted Dr. Morton. “The ASMBS looks forward to fulfilling its mission of lessening the burden of obesity by providing medical education, assuring patient safety and securing optimal outcomes with this new device.”
According to the FDA, “patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.”
“Patients suffering with moderate obesity that are struggling with poor success with diets, and are not candidates for surgery, now with the ReShape Dual Balloon have a new option that allows them to lose more weight than with just simple diet and exercise. It will be one more tool, performed endoscopically in an outpatient setting, that will be available at centers treating obesity,” concluded Dr. Jaime Ponce, the principal investigator of the REDUCE Pivotal Trial that validated the ReShape Procedure has a potential treatment option for obese patients.
The American Medical Association (AMA) declared in 2013 that obesity is a disease. Individuals with BMI greater than 30 are known to have an extremely higher risk of premature death (50 to 100%), and an increased risk of developing obesity-related diseases and medical conditions such as heart disease, type 2 diabetes and certain cancers, in comparison to healthy individuals. The Centers for Disease Control and Prevention (CDC) estimates that more than 72 million Americans are currently struggling with obesity, and with the disease’s strong connection with diabetes, addressing the epidemic is essential from a public health standpoint.