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,
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.)
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 w
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.
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