MON-LB104 Update on Anti-Obesity Medical Devices

Abstract

Background: Obesity is excess body weight for a given height. It is a worldwide pandemic associated with increased morbidity/mortality and high cost for the society. The prevalence of obesity has doubled in more than 70 countries since 1980. The prevalence of obesity in the United States of America (USA) is near 40% and its annual medical cost is around $200 billion. Management of obesity requires multidisciplinary approaches. Available options for weight reduction include diet, food supplement, exercise, behavior change, drug, medical device, gut microbiome manipulation, and surgery. In the USA, only 2% of subjects with obesity receive anti-obesity drugs. Properties and Mechanisms of Action: Anti-obesity medical devices represent a heterogenous family in terms of regulation, presentation, usage/administration, mechanism of action, effectiveness, safety, availability, and cost. Unlike anti-obesity drugs that act chemically through specific receptors, anti-obesity medical devices act rather mechanically. They do not have systemic absorption, specific metabolism, or receptors, and, therefore, have no side effects related to the impact on different organs through the bloodstream. Anti-obesity medical devices can cause weight loss through different mechanisms. They can cause a decrease in food intake at the level of oral cavity (by limiting the bite size) or stomach (by reducing the available stomach volume), or can cause a decrease in the amount of available/absorbed nutrient at the level of stomach (by removing part of the gastric contents) or intestine (by bypassing part of the intestine). In the USA, the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration is approving/clearing the anti-obesity medical devices. Based on the expected weight loss, CDRH categorizes medical devices as weight-loss devices (“more” weight loss) or weight-management devices (“less” weight loss). The weight-loss devices include gastric band devices, gastric space-occupying devices, and gastric emptying devices. The weight-management devices include oral removable palatal space-occupying devices and ingested transient gastric space-occupying devices. Anti-obesity medical devices should be used in conjunction with healthy lifestyle including diet and exercise. The degree of weight loss, the side effects, and the cost of anti-obesity medical devices vary considerably by the type of medical device. Conclusion: Anti-obesity medical devices are an option for subjects who have not responded to more conservative treatments (lifestyle, drugs) but who want an alternative to more aggressive interventions (bariatric surgery). Given the large market size of obesity treatment and the current level of undertreatment with anti-obesity drugs, anti-obesity medical devices can play a major role in the management of obesity.