Weight loss implant approved by FDA for partial use

An implant that curbs appetite by electrically stimulating stomach nerves has been approved by the FDA for use in some obese people in the United States.

An experimental group lost 24% of its excess weight or 9% of total body weight after 12 months of using the implant as against lower weight loss in another group that did not receive the device, FDA said.

The device that consists a rechargeable electrical pulse generator, wire leads and electrodes are implanted surgically into the abdomen, writes NPR.

It sends intermittent electrical pulses to the vagus nerve, which is involved in communication between the brain and stomach.

The vagal blocking device was developed by a US company EnteroMedics.

How exactly it works is not understood beyond the fact that it blocks the nerve and possibly helps control hunger pangs.

It has been approved only for treating patients aged above 18 years, who have not been able to lose weight and who have a body mass index (BMI) of 35 to 45 with at least one other obesity-linked condition, like type-2 diabetes.

External controllers allow the patient to charge the device and doctors to adjust its settings for optimum results without side effects.

The device was tested for safety and effectiveness in a clinical trial that included 233 patients with a BMI of 35 or greater.

Abdominal pain and heartburn were felt by a few participants.

However, the FDA has ordered EnteroMedics to follow at least 100 additional patients over the next five years to collect safety and effectiveness data on weight loss and side effects of the device.

Vagus nerve stimulation has been approved by the FDA to treat chronic or recurrent depression that does not respond to treatment, as well as epilepsy.

People with obesity are at increased risk of heart disease, stroke, type-2 diabetes and certain types of cancer.

The findings from the clinical study are published in the journal of the American Medical Association called JAMA.