FDA releases report for consumers on medical devices to treat obesity

More than 68 percent of U.S. adults are considered overweight, while nearly 36 percent of overweight people are considered obese. With that in mind, the FDA released a report for consumers on Aug. 16 on medical devices to treat obesity.

The FDA defined overweight as having a body mass index (BMI) from 25 to 29.99 and obese as having a BMI of 30 or higher. Still, it said BMI was not perfect metric because muscle weighs more than fat. However, Jeffrey Cooper, MS, DVM, a branch chief in the FDA’s Center for Devices and Radiological Health, said in the report that BMI was “a very good, easily accessible, indirect indicator of excess body fat for most people.”

Although the FDA recommends obese people improve their diet and exercise more, they sometimes also need help via medical devices.

The FDA has approved four types of devices to treat obesity in older adults: gastric bands, an electrical stimulation system, gastric balloons and a gastric emptying system.

Gastric bands are surgically implanted around the stomach, limit the amount of food a person can ingest and increase digestion time. The electrical stimulation system is surgically implanted into the abdomen, while gastric balloons are temporary devices that include one or two balloons that fill space in the stomach and are removed after six months. The gastric emptying system includes a tube placed in the stomach and a port that lies against the skin of the stomach.

Cooper said that patients who are candidates for the devices should read all patient materials and discuss the benefits and risks of each device with their physicians and healthcare providers.

The report noted that patients who have gastric bands and balloons must each much less at one sitting, while healthcare providers must monitor and provide lifestyle counseling for patients who use the gastric emptying system. It also noted that healthcare providers should monitor patients for the development of eating disorders.

“Risks vary for each device but can include nausea or vomiting, bleeding or infection,” the report said. “Some patients who receive treatment and make lifestyle changes (such as increased physical activity and healthy eating) still may not be able to lose weight or keep weight off.”