Before recommending a medical device, health care providers will probably want their patients to have tried lifestyle changes that include healthy eating and increased physical activity. Even if a person is prescribed a weight loss or weight management 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 overweight or to have obesity, according to federal statistics, with close to 38 percent of adults having 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
- surgery (such as gastric bypass surgery, in which a surgeon makes changes to your stomach and small intestine to change the way you absorb and digest food)
- 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-regulated medical devices have played a greater role in helping patients who are overweight or have obesity. These FDA-regulated medical devices can help patients lose or manage their weight and are classified as either “weight loss” or “weight management” devices based on the amount of weight a person is expected to lose.
These medical devices for weight loss and weight management require lifestyle changes and carry certain risks, and their placement can be less invasive than weight-loss surgery. Treatment benefits from these devices also 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 give counseling on which weight loss or weight management 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, for some weight-loss devices, a health care provider should evaluate you for an eating disorder or disordered eating patterns before you consider using a device as part of treatment for obesity. And if you are found to have an eating disorder – types include binge-eating disorder and bulimia nervosa – you should be treated for these disorders before considering using a device. That’s because an undiagnosed and untreated eating disorder can have serious health consequences for patients. Some weight-loss devices should not be used at all in patients with a history of eating disorders. Health care providers also may closely monitor patients who receive weight-loss devices for evidence of an eating disorder.
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 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 denser than fat, so an athlete can have a high BMI but little fat. However, at this time, BMI is considered as a good, easily accessible, indirect indicator of excess body fat for most people.
Which FDA-regulated devices are intended for weight loss?
Weight-loss devices are intended to help patients lose weight. Typically, 50 percent of patients lose at least 5 percent of their initial body weight with weight-loss devices, according to premarket data collected via pivotal clinical studies.
Currently, three types of FDA-regulated devices are intended for weight loss in certain adult patients age 18 and older: gastric bands, gastric balloons, and a gastric emptying system.
More information on each type of device appears below. If you have any questions, ask your health care provider.
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.
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 may be filled with gas or liquid (such as salt water). Once filled, balloons are then sealed. These devices should be removed at the time point specified in their labeling.
Gastric Emptying System
This type of device includes a tube placed in the stomach via an endoscope and a port that lies against the skin of the abdomen. It is 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.
A fourth type of device, an electrical stimulation system, was FDA approved and marketed; however, at this time, it is no longer marketed. If you have this type of device and/or have questions, please contact your health care provider.
Patients who use any of these devices should be monitored by a health care provider.
Which FDA-regulated devices are intended for weight management?
In general, when it comes to weight-management devices, you can expect to lose less weight than the amount of weight you might lose with a weight-loss device. Currently, two types of FDA-regulated devices are intended to help with weight management: oral space-occupying devices (used in the mouth) and stomach-space occupying devices. More information about each device appears below.
Oral Space Occupying Devices
This type of weight-management device is worn in the mouth during meals to limit bite size and is removable.
Stomach Space Occupying Devices
This type of weight-management device is a material that you swallow to temporarily occupy space in the stomach and help you feel full. For instance, one FDA-regulated device is a hydrogel that people take twice per day before lunch and dinner. The material mixes with foods they eat, creating larger volume, and passes through the body through the gastrointestinal tract.
What should you know about medical device risks and lifestyle changes in general—and what should you know about potential outcomes? Risks vary for each medical device but can include nausea or vomiting, bleeding, or infection. Some risks can be serious.
Also remember that medical devices can require lifestyle changes. 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.
If you’re a candidate for one of these devices, the FDA encourages you to read all patient materials. You also should consider whether you’re willing to make any necessary lifestyle changes. And discuss the benefits and risks of different treatment options with your health care provider so you can work together to make the best treatment choice.
Finally, understand that there are no guaranteed treatment results. Some patients who are treated with these devices and make lifestyle changes (such as increased physical activity and healthy eating) still may not be able to lose weight or keep weight off.
What should you know about reports of problems with these types of 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, including death. Other problems included sudden inflammation of the pancreas (called “acute pancreatitis,” which typically causes a sudden and severe stomach ache); and balloons filling with air and enlarging, causing discomfort (called “spontaneous over-inflation”). Both of these problems may necessitate early device removal.
Due to these reports, the FDA is monitoring these problems and advising health care providers to closely monitor patients who have liquid-filled 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 find more general information about FDA-approved medical devices for weight loss or weight management on the FDA’s website. And if you have any questions about these devices, please contact your health care provider.