Medical devices for weight loss and weight management
Photos courtesy of FDA.
U.S. Food and Drug Administration (FDA)
Weight-loss and weight-management devices go hand in hand with diet, exercise, and other lifestyle changes.
If your health care professional advises you to lose weight, you’re not alone. More than 70% of adults in the U.S. are overweight or have obesity, according to federal statistics, with more than 40% considered obese.
Overweight and obesity are linked to a long list of health problems that includes heart disease, stroke, diabetes, and certain types of cancer.
Losing weight can make a difference. For example, research shows overweight and obese adults with high blood pressure, high cholesterol and high blood sugar may start to see benefits by losing as little as 3% to 5% percent of their total weight. That’s 6 to 10 pounds for someone who weighs 200 pounds. And the more weight that’s lost, the greater the benefits.
When diet and exercise aren’t having enough of an effect, a health care professional may suggest a weight loss treatment that can include a prescription medication, bariatric surgery, or a medical device.
The U.S. Food and Drug Administration regulates medical devices, including those for either weight loss or weight management. Generally, people can expect to lose more weight with a weight-loss device than with one classified as weight-management.
This article gives an overview of FDA-regulated weight-loss and weight-management devices. Keep in mind, all medical devices have benefits and risks. And when it comes to losing weight and keeping it off, devices alone are not the solution. You’ll still need to watch your diet, exercise, and make other lifestyle changes your health care professional recommends.
FDA-Regulated Devices for Weight Loss
Three types of FDA-regulated devices are intended for weight loss in certain adult patients aged 18 and older.
• Gastric Bands
Gastric bands are surgically implanted around the stomach. The bands limit the amount of food a person can eat at one time and increase digestion time, which helps people eat less.
• Gastric Balloons
Gastric balloons are temporary devices that fill space in the stomach. One, two, or three balloons may 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). Depending on the device, the balloons may be filled with gas or liquid saltwater and then sealed. The devices should be removed at the time point specified in their labeling.
• Endoscopic Suturing Devices for Altering the Shape of the Stomach
An endoscopic suturing device is used to place sutures (stitches) in the stomach to make the size of the stomach smaller. A smaller stomach may limit the amount of food a person can eat at one time, which helps some people eat less.
Weight-Loss Devices No Longer Marketed in the U.S.
The FDA previously approved two other types of devices that are no longer marketed in the U.S. because of company decisions. According to the companies, removal from the U.S. market was not because of a safety issue.
The devices are a gastric emptying system known as the AspireAssist System and an electrical stimulation system known as the Maestro Rechargeable System or vBloc Neuromodulation System. If you have these types of devices or have questions, please contact your health care professional.
FDA-Regulated Devices for Weight Management
Two types of FDA-regulated devices are intended to help with weight management.
• Oral Space Occupying Devices
An oral space occupying device is a removable device worn only during meals. The device limits bite size, which reduces the amount of food a person can eat.
• Stomach Space Occupying Devices
A stomach space occupying device temporarily takes up room in the stomach, so users feel full. The device is swallowed and moves through and out of the body through the gastrointestinal tract.
Considerations Before Using a FDA-Regulated Weight-Loss or Weight-Management Devices
Talk with your health care professional about what you can expect from the device you are considering.
Risks vary for each medical device but can include nausea or vomiting, bleeding, or infection. Some risks can be serious requiring hospitalization, be life-threatening, or result in death.
You may have to make lifestyle changes beyond eating a healthy diet and getting more exercise. Certain devices require eating much less at one sitting, and more visits with a health care professional to check the device and provide lifestyle counseling.
There are no guaranteed treatment results. Some patients who are treated with these devices and make lifestyle changes still may not be able to lose weight or keep weight off.
Reports of Problems With Gastric Balloons for Weight Loss
Over the past few years, there have been reports of patient problems — and even death — related to weight-loss systems that use liquid-filled gastric balloons. Problems included sudden inflammation of the pancreasm called “acute pancreatitis,” which typically causes a sudden and severe stomachache; and balloons filling with air and enlarging, causing discomfort called “spontaneous hyperinflation.” Either may require removing the device.
The FDA worked with manufacturers to help health care professionals and patients recognize these problems and continues to monitor the problems.
Symptoms that could be signs of serious or even life-threatening problems include:
• Persistent stomach pain, back pain, or both.
• Persistent nausea, vomiting or both.
• Feeling as though your stomach may be swollen (bloating, with or without discomfort).
• Difficulty breathing.
• Chest pain.