Obesity is associated with a host of health issues including diabetes and heart disease. Often those struggling with obesity rely on various modifications of diet and activity level to treat their condition. However, over the past few years surgical options and medications have become available. Now the Food and Drug Administration (FDA) has approved a new medical device to treat obesity, but it comes with some serious risks.
FDA Approves New Obesity-Treating Medical Device
CBS News reports that the FDA has approved an implant that “curbs the appetite by electrically stimulating stomach nerves.” It is called the Maestro Rechargeable System and it is intended to treat extreme cases of obesity. The implant sends electrical signals to the nerves around the stomach which decreases hunger pangs and makes the patient feel full. The FDA has approved the device for use in adults aged 18 or older who have a body mass index between 35 and 45 and who suffer from at least one obesity-related condition like high blood pressure or diabetes. This is the first obesity-related medical device the FDA has approved since 2007.
Benefits of Device
The device does appear to have some effect on obesity. The clinical trial included 233 patients. The device was implanted in 157 of those patients, while the other 76 received a device that was not activated. After 12 months, the patients with the active device lost 8.5 percent more weight than the control group. Just over half of the patients lost at least 20 percent of their excess weight and just under forty percent lost at least 25 percent of their excess weight in that one year.
Risks of the Device
While the device may sound promising for some individuals who have struggled with their weight, it is not without its risks. According to USA Today, not all experts think the rewards are worth the risks. One such expert is Dr. Priscilla Hollander. She points out that some of the patients in the clinical trials lost “20% of their excess weight.” If an individual is 50 pounds over weight and they lose 20 percent of that excess weight, that means that they only lost 10 pounds. While some weight loss is better than none, a mere ten pounds may not be worth the risks inherent in any surgery. The device also fails to address any of the psychological factors that contribute to obesity such as emotional eating or depression.
The FDA reports that serious adverse events related to the device include nausea, pain at the neuroregulator site, vomiting, and surgical complications. Surgical complications can include anesthesia complications, which can result in serious injury or death. Excess bleeding is another risk, as are blood clots. Infection is another possibility, as is delayed recovery and difficulty breathing. Surgery can also cause scarring, swelling, and bruising. While the vast majority of surgeries do not result in complications, you must consider these possibilities and weigh them against the benefits of the device before choosing this sort of treatment.
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