FDA CONSUMER HEALTH INFORMATION: Medical Devices that Treat Obesity: What to Know

SILVER SPRING, Md., Aug. 16, 2016 /PRNewswire-USNewswire/ -- If your health care provider finds that you're overweight or obese, you're not alone. More than 68 percent of U.S. adults are considered overweight, according to federal statistics. And close to 36 percent of those are considered obese.

Obesity is linked to health issues like heart disease, diabetes, and high blood pressure. And since losing weight starts with healthy eating and exercise, your health care provider can give advice on lifestyle changes that can help.

In general, when diet and exercise are not effective, weight loss treatments can include prescription medications, invasive surgery, and medical devices. All have risks and benefits.

In recent years, FDA-approved medical devices have played a greater role in treating obesity. Treatment benefits from these devices may be greater for patients with obesity-related health problems like high blood pressure.

Your health care provider should provide counseling on which option—if any—may be right for you. And if you're a treatment candidate, he or she should help you understand what treatment involves and how it will affect your lifestyle.

"In the past, there was diet and exercise, and then there was invasive surgery, including gastric bypass surgery and gastric sleeve surgery," says Jeffrey Cooper, M.S., D.V.M., a branch chief in the FDA's Center for Devices and Radiological Health. "Today, medical devices for obesity treatment require lifestyle changes and carry certain risks, but their placement can be less invasive."

How is obesity measured?

Obesity is typically measured by calculating body mass index (BMI), which considers your height and weight. A BMI outside the range of what is considered healthy can fall into two categories: overweight or obese. A BMI from 25 to 29.99 is considered overweight. A BMI of 30 or more is considered obese. (Don't know where you fall? The Centers for Disease Control and Prevention has a BMI calculator at http://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html.)

Though BMI is a widely-used screening tool, it is not perfect. "There are situations where BMI is not an appropriate measure. For instance, muscle weighs more than fat, so an athlete can have a high BMI but little fat," says Cooper. "However, at this time BMI is a very good, easily accessible, indirect indicator of excess body fat for most people."

Currently marketed FDA-approved medical devices to treat obesity are indicated for obese patients, although specific BMI requirements vary by device.

Which devices has the FDA approved to treat obesity?

The FDA regulates medical devices in the United States and evaluates certain devices for safety and effectiveness before they can be marketed. When FDA-approved medical devices are placed in a person's body ("implanted"), some can be removed or adjusted. But devices, like other medical treatments, have risks, notes FDA medical device reviewer Martha Betz, Ph.D.

Currently, four types of devices are approved to treat obesity in certain adult patients age 18 and older: gastric bands, an electrical stimulation system, gastric balloons, and a gastric emptying system. Patients with these devices should be monitored by a health care provider.

Risks vary for each device but can include nausea or vomiting, bleeding, or infection. 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.

Gastric Bands

These bands are surgically implanted around the stomach. They limit the amount of food a person can eat at one time and increase digestion time, which helps people eat less.

Electrical Stimulation System

This system is surgically implanted into the abdomen to block nerve activity between the brain and the stomach. It includes nerve electrodes, wire leads, and a rechargeable electrical pulse generator that delivers electrical signals to electrodes. External controllers let the patient charge the device and let health care professionals adjust settings. (The process of electric stimulation is understood, but specific reasons for why this helps with weight loss are unknown.)

Gastric Balloons

These temporary devices include one or two balloons that fill space in the stomach. They're placed using an endoscope (a long flexible tube with a small camera and light at the end). Then they're filled with salt water (saline) and sealed. Balloons should be removed after six months.

Gastric Emptying System

This recently approved device includes a tube placed in the stomach via an endoscope and a port that lies against the skin of the abdomen. It's not approved for use in certain patients, including those who have eating disorders such as bulimia. It's used to drain a portion of the stomach contents into a receptacle 20 to 30 minutes after meals. It must be shortened by a health care provider as patients lose weight (and girth) so the port continues to lie against the skin. Recipients must thoroughly chew all food, among other lifestyle changes and may have the device removed when they reach their target weight.

What else should you know—and how can you report device problems?

"If you're a candidate for one of these devices, the FDA encourages you to read all patient materials," says Cooper. "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."

For instance, some devices—including gastric bands and balloons—require patients to eat much less at one sitting. (If patients eat too much, they can get sick.)

And the gastric emptying system requires frequent medical visits to a health care provider who monitors device use and provides lifestyle counseling. Health care providers also should monitor patients for the development of eating disorders; if one develops, device removal may be required.

"People should consider whether they're willing to make the necessary lifestyle changes," Cooper says.

Finally, if you're ever injured while using an FDA-regulated device—or if the device malfunctions—the agency encourages you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch).

For more information about obesity treatment devices, visit http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ObesityDevices/default.htm.  

This article appears on the FDA's Consumer Updates page, which features the latest on all FDA-regulated products: http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm.

Contact: FDA Office of Media Affairs, 301-796-4540, [email protected] 

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SOURCE U.S. Food and Drug Administration

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