Facts about FDA-Approved Medical Devices for Treating Obesity
Here are the basic facts you need to know when considering using these FDA-approved medical devices for treating obesity.
According to a recent Consumers Updates by the FDA, obesity is serious health problem that is strongly linked to health issues like heart disease, diabetes, and high blood pressure. Therefore, taking care of your obesity problem may be the best way to tackle your health issues.
The FDA’s recommendation is to always initially give diet and exercise a chance toward losing your excess weight. However, FDA health officials also recognize that in many cases, diet and exercise are not enough and encourage patients who are overweight and obese to consider alternative treatments that include medications, surgery and medical devices.
“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.”
The following is a summary of facts presented in the FDA’s Consumers Updates to help patients understand the help FDA-approved medical devices can provide for treating their obesity.
Basic Fact #1: 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, with close to 36 percent of those diagnosed as obese.
Basic Fact #2: Losing weight starts with healthy eating and exercise. But when diet and exercise are not effective, weight loss treatments such as prescription medications, invasive surgery, and medical devices; however, all have risks and benefits.
Basic Fact #3: Patients with obesity-related health problems like high blood pressure may benefit the most from FDA-approved medical devices for weight loss.
Basic Fact #4: Obesity is typically measured by calculating your body mass index (BMI), that factors in your height and weight. A BMI ranging from 25 to 29.99 is considered overweight. A BMI of 30 or more is considered obese.
Basic Fact #5: Although the 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 Dr. Cooper. “However, at this time BMI is a very good, easily accessible, indirect indicator of excess body fat for most people.”
Basic Fact #6: Currently, there are four types of devices are approved to treat obesity in adults: gastric bands, an electrical stimulation system, gastric balloons, and a gastric emptying system―all of which require monitoring by a health care provider. The FDA describes each of the devices as follows:
• 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.
Basic Fact #7: All of the aforementioned devices have risks associated with them such as nausea or vomiting, bleeding, or infection. In addition, the likelihood is high that a patient will have to undergo more than one surgery related to any weight loss device.
Basic Fact #8: In spite of undergoing treatment with an FDA-approved medical device for weight loss, some patients who receive treatment and also make lifestyle changes such as increased physical activity and healthy eating still may be unable to lose weight or keep lost weight off.
Final Recommendations by the FDA
“If you’re a candidate for one of these devices, the FDA encourages you to read all patient materials,” says Dr. 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…People should consider whether they’re willing to make the necessary lifestyle changes,” added Dr. Cooper referring to facts that some patients may not initially be aware of such as:
• 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.)
• The gastric emptying system requires frequent medical visits to a health care provider who monitors device use and provides lifestyle counseling.
• Expect your health care providers to monitor you for the development of eating disorders; if one develops, device removal may be required.
And, 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.
For more about FDA-approved medical devices for treating obesity, here are some select articles for your benefit:
Reference: FDA Consumer Updates―”Medical Devices that Treat Obesity: What to Know”
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