Approved for a Medical Device to Treat Obesity? Here's What You Should Know
Even when using a treatment device, obesity patients must still change their lifestyles
The prevalence of obesity in the United States is startling. According to federal statistics, more than two thirds of adults are considered either overweight or obese; more than one third of adults are considered definitively obese; and nearly three out of four men are considered either overweight or obese. "Overweight" is defined as having "an excess amount of body weight that may come from muscles, bone, fat, and water," while "obesity" is defined as having "an excess amount of body fat."
Because obesity is related to health problems such as heart disease, diabetes, and high blood pressure, it is important that patients know as much as possible about all available treatment options.
Treatment Options for Obesity
The first option that healthcare providers will likely prescribe is lifestyle changes. Healthy eating and exercise are necessary for everyone, but especially for people trying to lose weight.
However, lifestyle changes are not enough for some patients. In these cases, other weight loss treatments may be considered, such as prescription medications, surgery, or medical devices. Patients considering any of these options should know about their risks and benefits prior to making any final treatment decisions.
Medical devices approved by the U.S. Food and Drug Administration (FDA) have been playing a greater role in obesity treatment in recent years. Patients who have health problems related to their obesity, such as high blood pressure, may benefit more from treatment using such devices than those who do not.
If a patient is considering obesity treatment of any kind, he or she should consult a healthcare professional, who will help the patient to understand all aspects involved in treatment and how treatment will affect the patient's 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, but their placement can be less invasive."
How Obesity is Measured
Healthcare providers generally measure a patient's level of obesity by calculating his or her body mass index (BMI), which factors in the patient's height and weight. There are two categories in which a BMI may be placed if it falls outside the range of what is considered healthy: overweight or obese. A patient with a BMI in the range of 25 to 29.99 is considered overweight, while one with a BMI of 30 or higher is considered to be obese.
Although BMI is widely used as a screening tool, it has faults. "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," explains Cooper. "However, at this time BMI is a very good, easily accessible, indirect indicator of excess body fat for most people."
Medical Devices for Treating Obesity
FDA-approved medical devices for treating obesity that are currently on the market are indicated for patients who are obese, though the devices vary regarding the particular BMI requirements necessary for use.
In the U.S. , medical devices are regulated by the FDA, which evaluates them for safety and effectiveness before they can go on the market. Some such devices can be removed or adjusted after being placed, or "implanted," in a person's body. However, as noted by FDA medical device reviewer Martha Betz, Ph.D., the devices do have risks, just like other medical treatments.
There are currently four types of medical devices approved for treating obesity in certain adults who are 18 or older. These include gastric bands, an electrical stimulation system, gastric balloons, and a gastric emptying system. Anyone using these devices should be monitored by a healthcare professional.
Gastric bands are bands that limit how much a patient can eat at one time and increase digestion time, which helps people to eat less. They are implanted around the stomach through surgery.
Electrical stimulation systems are also implanted surgically, but are placed into the abdomen rather than the stomach in order to block nerve activity between a patient's brain and stomach. The system includes nerve electrodes, wire leads, and a rechargeable electrical pulse generator that transmits electrical signals to the electrodes. The device is charged via external controllers, which also allow healthcare professionals to adjust settings. Although scientists understand the electric stimulation process, it is not known why the process helps patients lose weight.
Gastric balloons are temporary devices that fill up stomach space. One or two are placed into the stomach using an endoscope, filled with salt water, and sealed. Gastric balloons should be removed after six months.
Gastric emptying systems are not approved for use in certain patients, such as those who have eating disorders. The system includes a tube placed into the stomach using an endoscope and a port that lies against the skin of the abdomen, and it drains a portion of stomach contents into a receptacle between 20 and 30 minutes after a meal. Healthcare professionals must shorten the device as the patient loses weight and girth so that the port will remain in place against the skin. Patients using this device must thoroughly chew all food and may have the system removed upon reaching their target weight.
Risks and Additional Information
Risks vary according to the device but may include nausea, vomiting, bleeding, or infection. In addition, there are some patients who, although they are using the device and have made lifestyle changes such as exercise and eating healthily, still may not be able to lose weight or to keep it off.
Anyone considering one of these devices is encouraged to read all patient materials and to discuss the risks and benefits of different treatment options with his/her healthcare provider. Patients should also consider whether or not they are willing to make the necessary lifestyle changes required by treatment. Providers should monitor patients in case they develop an eating disorder, in which case the device may need to be removed.
Any patient injured while using a device regulated by the FDA, or who experiences a device malfunction, is encouraged to file a voluntary report by calling (800) 332-1088.