Tag Archives: device

FDA Approves New (Torture?) Device for Fatties

I guess I should have seen it coming.  We’ve seen forks that talk to you and bracelets that shock you for eating too much.  We’ve seen painful patches you sew on your tongue, balloons you blow up in your guts and dramatic rerouting of your internal plumbing and drugs that cause high blood pressure, irreversible heart damage and death all in the name of weight loss.

Today, the FDA approved a new implanted electronic device for helping fatties lose weight.  Now, we don’t know that this product will fail as so many have before it.  It’s possible that this will be the miracle all the fat-hating world has been seeking.  But I have to say, I has a concerned.

Concerned kitteh is concerned.

First of all, let’s talk about the device.  According to the FDA News Release:

The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.

Okay, first off, this abdominal lobotomy machine somehow uses electricity to block nerve activity between the brain and the stomach.  Is anybody else even a tiny bit uncomfortable about this?  I mean isn’t that connection between your mind and the fuel tank of your body kind of important?  What about cravings for things our bodies need?  We just do away with all of those?  Personally, I think that the link between my stomach is kind of important.

And then we get to the part that says, “the specific mechanisms for weight loss due to use of the device are unknown.”  Um, okay.  So somehow disrupting a key process of your body makes you lose weight, but we aren’t sure why.  It could be that you get the feeling of being full sooner.  It  could be that the tiny device is receiving signals from aliens from another star system that, frustrated with efforts to starve the human race by planting celebrity “fat shots” into the National Enquirer, have turned to more direct methods.  (It does stimulate the “Vagus Nerve” after all.)

It’s how the MIB know what’s what…

Now let’s talk about efficacy.  You know, whether or not it works.  The FDA approved this device despite it’s failure to meet the primary endpoint.  What does this mean?  It means that the device using group would lose at  least 10 percent more excess weight than the control group.  But despite missing this important marker, the device was approved because AAARGH, DEATHFAT, PANIC!  Now let’s look at the statistics.

The release states that a clinical trial was conducted with a whopping 233 patients.  The group with the functional version of the device lost 8.5 percent more weight than those with the non-functional version of the device and kept it off for 18 months.   So far that’s as far out as they have studied.  Despite the fact that most weight loss products, programs and potions work for 18 months.  Despite the fact that virtually every other weight loss product, program, plan or potion starts to fail shortly after that, leading to mass failure and frequently even higher weights within 5 years.

But that’s okay, because the FDA has rules, right.  The press release states:

As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions.

So the manufacturer (which has NO conflict of interest, right?) will conduct an ongoing study on less than half of the original patients to see if this thing works long term and/or causes more problems than it solves.  Uh huh.  In the mean time, the company that has created this thing faces unmitigated joy as their capital and stock prices rise.  By time we figure out that this thing is causing really big problems, or doesn’t work long term or is receiving signals from the Vega system, the guys that created this will be on their second yacht and summer home in Vail.  But that’s okay too, because AAARGH, DEATHFAT, OBESIPANIC!!!!!

I’m sighing deeply right now as I contemplate just how many more folks will sell their cows for this handful of magic beans, and how big and angry the giant will be, and who will be around to slay it.

Don’t mind me.  I’m going to do something I know will improve my health long term.  I’m just gonna shut off the computer and go for a walk.

Love,

Jeanette DePatie (AKA The Fat Chick)

P.S. Want to hear Jeanette speak at your organization about sensible, sustainable, and research-driven ways to improve your health?  Click here.

P.S.S. Wanna buy stuff that will help you start and stay exercising?  Click here.

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