The World Health Organization defines obesity as having a body mass index (BMI) greater than or equal to 30. Similarly, having a BMI greater than or equal to 25 is considered overweight. Across the globe, worldwide obesity levels have nearly doubled since the early 1980s.
More than 70% of U.S. adults are considered to be overweight and 38% suffer from obesity, which is also linked to serious health concerns including heart disease, diabetes, and high blood pressure.
The U.S. Food and Drug Administration (FDA )takes obesity seriously and does all it can to improve daily living for individuals and families across the country. The FDA regulates roughly $417 billion worth of domestic food and $49 billion worth of imposed foods. In addition to monitoring and regulating foods, the administration has been working on developing new ways and innovative devices to combat obesity.
“Today, medical devices for obesity treatment require lifestyle changes and carry certain risks, but their placement can be less invasive,” said Jeffrey Cooper, M.S., D.V.M., branch chief in the FDA’s Center for Devices and Radiological Health.
Here are some of the FDA-regulated medical devices that are currently on the market to treat obesity:
- Gastric Emptying Systems — This device involves inserting a tube between a patient’s stomach and outside of the abdomen to drain food after consumption.
- Electrical Stimulation Systems — This system is an electrical stimulator placed inside the abdomen and can block nerve activity between the stomach and the brain.
- Gastric Bands — Gastric bands are placed around the upper portion of the stomach and leave only a small portion available for food.
- Gastric Balloon Systems — These are inflatable balloons that are placed inside the stomach to take up space.
Before beginning any kind of obesity treatment, however, it’s recommended to consult with a medical professional and discuss your medical history, including eating habits, family history, and how your weight has fluctuated over the years.
Additionally, according to EMPR, the FDA has recently updated its labeling requirements for two obesity treatments: Orbera and ReShape, both of which are gastric balloon systems.
The new labeling requirements will provide additional safety information regarding the risk of spontaneous hyperinflation, acute pancreatitis, and death associated with these weight-loss devices.
“These updates provide important enhancements to our existing labeling and support our continued emphasis on patient safety,” said Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery. “Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events.”
These new labeling requirements include updated information on the global rate of occurrences related to these dangerous medical complications, as well.
“If you’re a candidate for one of these devices, the FDA encourages you to read all patient materials,” Cooper added. “Patients should discuss the benefits and risks of different treatment options with their health care providers so that they can together make the best treatment choice. People should consider whether they’re willing to make the necessary lifestyle changes.”