Medical Devices that Treat Obesity: What to Know
Before a medical device is recommended, doctors will probably want their patients to have tried lifestyle changes that include healthy eating and increased physical activity. Even if a person is prescribed an obesity treatment device, he or she still must make lifestyle changes.
If your health care provider finds that you’re overweight or have obesity, you’re not alone. More than 70 percent of U.S. adults are considered to have overweight or obesity, according to federal statistics. And close to 38 percent of those have obesity.
Obesity is linked to health issues like heart disease, diabetes, and high blood pressure.
In general, when diet and exercise are not effective, weight loss treatments can include prescription medicines, invasive surgery, and medical devices. But prior to prescribing medicine or recommending surgery, doctors will probably want their patients to demonstrate healthy lifestyles that include better nutrition and increased physical activity.
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. But all devices have risks—and some risks may be serious.
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.
For instance, a health care provider should evaluate you for an eating disorder before you consider an obesity device. And if you are found to have an eating disorder—types include binge-eating disorder and bulimia nervosa—you should be treated before considering these medical products. That’s because an undiagnosed and untreated eating disorder can have serious health consequences for patients, and in fact, some obesity-treatment devices should not be used at all in patients with a history of eating disorders. (Health care providers may also closely monitor patients who receive obesity devices for evidence of an eating disorder.)
“Today, medical devices for obesity treatment require lifestyle changes and carry certain risks, but their placement can be less invasive,” says Jeffrey Cooper, M.S., D.V.M., a branch chief in the FDA’s Center for Devices and Radiological Health.
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 obesity. A BMI from 25 to 29.99 is considered overweight. A BMI of 30 or more is considered to be obesity. (Don’t know where you fall? The Centers for Disease Control and Prevention has a BMI calculator.)
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 is more dense 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 patients who have obesity, although specific BMI requirements vary by device.
Which devices are FDA-approved—and what about risks and lifestyle changes?
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.
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. Also remember that some risks can be serious.
“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. Remember that health care providers may also 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, understand that there are no guaranteed treatment results. Some patients with these devices 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.
The following section contains more information about FDA-approved devices.
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.)
These temporary devices can include one, two, or three balloons that fill space in the stomach. They can be placed via a swallowable capsule attached to a thin catheter or via an endoscope (a long flexible tube with a small camera and light at the end). Then, depending on the device, they’re filled with gas or salt water (saline). Balloons filled with salt water are then sealed, and all 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 should you know about reports of problems with medical devices?
In February 2017, August 2017, and June 2018, the FDA issued letters to health care providers based on reports of patient problems related to liquid-filled gastric balloon systems to treat obesity. These problems included sudden inflammation of the pancreas (called “acute pancreatitis,” which typically causes a sudden and severe stomach ache); balloons filling with air and enlarging, causing discomfort (called “spontaneous over-inflation”); and deaths in patients.
Due to these reports, the FDA is now monitoring these problems and advising health care providers to closely monitor patients who have gastric balloons for complications. The FDA also is advising health care providers to explain symptoms that could be signs of serious or even life-threatening problems—and to advise patients what to do if these symptoms happen.
If you’re ever injured while using an FDA-regulated device—or if the device doesn't work properly—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. If you ever have an emergency, first call 9-1-1.
You can learn more general information about FDA-approved medical devices that treat obesity on the FDA’s website. And if you have any questions about these devices, please contact your health care provider.