In what seems like an inevitable march toward technological ways to help obese people lose weight, the Food and Drug Administration (FDA) has approved the use of a device that fools the brain into thinking your stomach is full.
Called the Maestro Rechargeable System (MRS), the device is implanted in the chest and runs electrical wires to the vagus nerve, which naturally regulates stomach emptying and signals to the brain whether the stomach feels empty or full. At fixed times signals are sent to the nerve to make the user feel full.
Similar to a pacemaker, the MRS was approved once a study found that, after a year, experimental patients lost 8.5 percent more of their “excess weight” than those in a control group. The FDA is, however, requiring the manufacturer to conduct a five-year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data.
“The treatment sounds simple. Just distract the stomach so it does not feel hungry,” wrote Mary Pickett, MD, a Harvard University faculty member and senior medical editor for Harvard Health Publications. “Interested news followers have snapped to attention. But don’t get your hopes up. The device may disappoint us. It is frankly too early – and the evidence too weak – for doctors and patients to be excited about this treatment.”
“I have been following along for the last 10 years as small studies have looked at devices like this, and their possible role in obesity treatment. Some studies have shown no clear weight loss at all. Others have shown a very modest benefit, and many side effects.”
A recent Lancet editorial co-authored by Christopher Ochner, PhD, an obesity expert at Mount Saini Hospital in New York City, asserts that traditional approaches to treating obesity, mainly diet control and exercise, may not be enough to help patients lose weight and keep it off. The authors argue that obesity is a chronic disease with biological aspects as well, and it will require biological treatments such as the MRS.
Further, they contend that reducing calories to lose weight actually triggers biological systems that tell the body to eat high-calorie foods to gain the weight back.
Given the evidence on the MRS so far, a family medicine specialist at Mercy Medical Center in Baltimore, Kathryn Boling, MD, questions whether the treatment outweighs the risk, such as serious side effects reported in the clinical study including nausea, vomiting, and surgical complications.
“The (MRS) may indeed offer weight loss in a less invasive manner than gastric bypass surgery, but is it as effective…or even effective at all?” she says. “For now, I think these questions cannot be answered reliably.”
“Relatively few patients have had the device implanted, and the longest time the device has been used is seven years. In time, this device may prove to be a wonderful addition to weight loss treatments…or not. Until then, I would advise my patients to wait.”
March 02, 2015
Christopher Nystuen, MD, MBA