It’s being called a “pacemaker” for your stomach.
But unlike a real pacemaker, no one is exactly sure how the Maestro device works.
Not the FDA –and not even EnteroMedics, the company that makes it.
And in the clinical trial done to test this mystery method of appetite control, Maestro didn’t even meet its “endpoint.” That’s the goal set to show if a drug or device actually works.
But not to worry! The FDA’s advisory committee said that Maestro’s benefits still outweighed its risks.
How wrong they are…
The hunger games
The “Maestro Rechargeable System” is an electrical “pulse” generator that’s surgically implanted in your belly. Its job is to block signals from a nerve pathway to your brain. And then to trick your brain into thinking you’re not hungry.
And it does that by manipulating your vagus nerve.
The vagus nerve, also called the “wandering” nerve, stretches all the way from your abdomen, through you heart, esophagus and lungs, and ends up in your brain stem.
And Maestro gives that vagus nerve high frequency bursts of power. All day. Every day.
What could possibly go wrong with that?
Well, nothing – if you believe the FDA’s survey.
That’s right, a survey.
It was the FDA’s first ever survey to figure out “patient risk tolerance.”
In other words, how much risk – such as the “probability of death” – will the average subject accept for whatever benefit this device might deliver?
Of course, even a humdinger of a survey like that won’t be able to predict the real world risks that this device might trigger. The FDA already knows that it causes pain where it’s inserted, as well as problems swallowing, nausea and chest pain. And of course there can be surgical complications.
But we’re going to have to wait a while to see what really happens to folks who get this device inserted in their abdomens.
The company that makes Maestro has been told to follow a minimum of 100 such people for the next five years. The FDA wants to find out if they really lose weight – and of course what side effects might turn up.
The idea that people are so desperate to lose weight that they would submit to this level of experimentation is horrifying.
And that the FDA would rubber-stamp it without having any idea of the side effects makes them a knowing accomplice, entirely responsible for any negative outcomes.
Just imagine how severe the effects could be of overtaxing one of the key nerves in your heart and brain center.
It is beyond belief to me that we are allowing this to happen.
The EnteroMedics CEO called the FDA’s approval of Maestro a “transformational event” for obese people.
Of course, he fails to say what it might actually transform them into.
FDA clears ‘pacemaker for the stomach’” Thomas M. Burton, January 14, 2015, The Wall Street Journal, wsj.com