People Were Unwittingly Implanted With Fake Devices In Medical Scam, FBI Alleges (vice.com) 55
Chronic pain patients were implanted with "dummy" pieces of plastic and told it would ease their pain, according to an indictment charging the former CEO of the firm that made the fake devices with fraud. Motherboard reports: Laura Perryman, the former CEO of Stimwave LLC, was arrested in Florida on Thursday. According to an FBI press release, Perryman was indicted "in connection with a scheme to create and sell a non-functioning dummy medical device for implantation into patients suffering from chronic pain, resulting in millions of dollars in losses to federal healthcare programs." According to the indictment, patients underwent unnecessary implanting procedures as a result of the fraud. Perryman was charged with one count of conspiracy to commit wire fraud and health care fraud, and one count of healthcare fraud. Stimwave received FDA approval in 2014, according to Engadget, and was positioned as an alternative to opioids for pain relief.
The Stimwave "Pink Stylet" system consisted of an implantable electrode array for stimulating the target nerve, a battery worn externally that powered it, and a separate, 9-inch long implantable receiver. When doctors told Stimwave that the long receiver was difficult to place in some patients, Perryman allegedly created the "White Stylet," a receiver that doctors could cut to be smaller and easier to implant -- but was actually just a piece of plastic that did nothing. "To perpetuate the lie that the White Stylet was functional, Perryman oversaw training that suggested to doctors that the White Stylet was a 'receiver,' when, in fact, it was made entirely of plastic, contained no copper, and therefore had no conductivity," the FBI stated. "In addition, Perryman directed other Stimwave employees to vouch for the efficacy of the White Stylet, when she knew that the White Stylet was actually non-functional." Stimwave charged doctors and medical providers approximately $16,000 for the device, which medical insurance providers, including Medicare, would reimburse the doctors' offices for.
The Stimwave "Pink Stylet" system consisted of an implantable electrode array for stimulating the target nerve, a battery worn externally that powered it, and a separate, 9-inch long implantable receiver. When doctors told Stimwave that the long receiver was difficult to place in some patients, Perryman allegedly created the "White Stylet," a receiver that doctors could cut to be smaller and easier to implant -- but was actually just a piece of plastic that did nothing. "To perpetuate the lie that the White Stylet was functional, Perryman oversaw training that suggested to doctors that the White Stylet was a 'receiver,' when, in fact, it was made entirely of plastic, contained no copper, and therefore had no conductivity," the FBI stated. "In addition, Perryman directed other Stimwave employees to vouch for the efficacy of the White Stylet, when she knew that the White Stylet was actually non-functional." Stimwave charged doctors and medical providers approximately $16,000 for the device, which medical insurance providers, including Medicare, would reimburse the doctors' offices for.
Price of Plastic (Score:1)
The question is (Score:3)
Did it work?
I'm not kidding here: now that the cat's out of the bag, clearly it won't work for anybody anymore. But this was a placebo - and a rather sophisticated one at that - and placebos are known to work sometimes for those who believe in them.
Re:The question is (Score:4, Insightful)
It may continue to work (Score:5, Informative)
There are stories about people put on a placebo in double blind trials, finding it working, and that it continues to work even when they're told they were administered a placebo.* Ben Goldacre's book 'Bad Science' has an amazing chapter on Placebos; it's a crazy world.
See also
https://www.health.harvard.edu... [harvard.edu]
* I thought I got that claim from Goldacre but a quick scan didn't reveal it.
It worked even without placebo effect... (Score:5, Informative)
The scheme worked regardless of it working for the patients or not, regardless of potential placebo effect. It was a Medicare-siphoning scheme.
https://www.justice.gov/usao-s... [justice.gov]
STIMWAVE sold the Device to doctors and medical providers for over approximately $16,000. Medical insurance providers, including Medicare, would reimburse medical practitioners for implanting the Device into patients through two separate reimbursement codes, one for implantation of the Lead and a second for implantation of the Pink Stylet.
The billing code for implanting the Lead provided for reimbursement at a rate of between approximately $4,000 and $6,000, while the billing code for implanting a receiver, like the Pink Stylet, provided for reimbursement at a rate of between approximately $16,000 and $18,000.
https://www.ihurt.com/peripher... [ihurt.com]
Before the device is implanted permanently, there is typically a trial period to determine if the therapy is effective for your chronic pain. PNS is covered by most insurance plans.
Consult with your doctor to learn more about Stimwave StimQ PNS.
I.e. Stimwave sells the pain-relief gadget to doctors, doctors implant the gadget and are fully refunded (plus procedure costs) by Medicare - and if it doesn't work for particular patient's PARTICULAR chronic pain, the implant is removed.
But everyone gets to keep their money - resulting in a Medicare to Stimwave money pipeline. Pain relief could be fake or not, but money be real.
Bonus points for calling the gadgets Freedom Stimulators. [squarespace.com]
I'm getting all eagle and starstripes teary-eyed here and I'm not even a Mericun.
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You also need to take into account that patients had surgery, recovery, and potential complications. For nothing. They definitely suffered damage.
In principle, yes. In practice... (Score:2)
In principle, yes. In practice... it was an outpatient, elective, procedure done through a needle-sized incision. Which is another reason why it was so popular.
Basically, you go and have a piercing done and the constant pain in your back/neck/legs stops. What's not to like?
Plus, patients probably signed a bunch of waivers before the procedure. Including the "maybe it won't work for you anyway, we don't know..." one.
And any complications would have been on the doctors' end. But if a surgeon can't do properly
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But this was a placebo
Then it should be registered as such. Placebos are very real things in the medical world which are allowed to be prescribed by doctors and covered by various heath fund. But at no point is the manufacturer misrepresenting what this does to the doctor or the FDA.
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Only works if they carry a mobile phone ;)
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At least they wiped the screen of the phone down with magic alcohol that leaves an invisible film that is totally not just insurance that will prevent it from cracking or you can get a new phone by sending in the warranty papers you paid for but lost because you were under the impression there would be an actual physical barrier to the screen cracking.
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That was clearly fake. Neither did I get better reception with my cellphone nor did I get awesome Magneto powers.
I feel ripped off.
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Magneto powers only work if you charge the nano-bots periodically with microwaves.
Plus, if you want anything more than picking up pins and paperclips with your fingers, you'd need either an industrial-sized microwave OR to charge your brain for at least a couple of hours every day.
And it is really a hassle to set up a microwave so it works with the door opened, on top of your head, as you sit in your chair and watch TV, read or whatever.
Sure, you could set it up on your bed and lie down, with your head in t
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You only happens for really low intelligence people. And these are not smart enough to ask for compensation. Sorry, you are screwed. I, on the other hand, got the real vaccine.
Plastics can be conductors (Score:3)
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Yes. But that typically looks different than the surrounding material. And the other problem is that this needs to be a loop to work for this power-transfer application. You cut it anywhere and it is not a loop anymore and stops working. Some of the surgeons that cut this should have gotten suspicious early on and they would have had a sample to take to an expert.
Re: Plastics can be conductors (Score:2)
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You don't have to have a loop for power transfer, you can transfer RF power without a loop, think microwave or light. You have to have a loop to complete a circuit and transfer power with electrons.
You do to transfer meaningful amounts of power at high efficiency which is needed for medical applications. It’s the difference between near field transmission and regular microwaves or light which both behave much differently near field. Ask yourself why wireless charging phones and toothbrushes need to be set on a pad and not just left anywhere.
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You do not do high-energy RF transfers in human bodies.
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Re:Plastics can be conductors (Score:4, Insightful)
FDA did not approve the plastic. There was another receiver that was approved apparently, but too big for some patients. they bypassed it all, *knowing* it did not work. Did they retune the transmitter to work with a string of plastic? Absolutely not.
The real crime and reason for FBI involvement (Score:1)
This defrauded the insurers.
Re:The real crime and reason for FBI involvement (Score:4, Insightful)
This defrauded the insurers.
That is why the FBI is involved, regardless of it being "the real crime". The federal government normally doesn't have jurisdiction over typical harm/damage crimes (theft, assault and battery, etc.). In this case, the federal government does have jurisdiction over the crime of stealing money from the federal government (specifically Medicare). The harm caused to individual people is a case for state courts.
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A lot of states are keen on loosening FDA oversight. They claim it takes too long for drugs to be approved, etc. If they allow in untested remedies we'll get more and more stories like this. When money is involved, quite a lot of people quickly decide to be scum in order to get some of it. I suspect some state attorneys won't bother until there's a public outcry.
Problems in the US don't get solved if there's no outcry that causes political entities to act. The US is not proactive but reactive.
But, but, (Score:2)
I mean, we had to wait several months before the Covid vaccinations were allowed. (with or without tracking nanobots)
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Medical Devices have a different process and different laws than drugs do; plus the FDA has always been underfunded with a well funded industry which bought off one whole political party and enough of the other party. They self-regulate with "oversight" as a result.
I suggest a good intro is on Netflx "Watch The Bleeding Edge" specifically about the device industry in the USA.
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Shouldn't medical devices be approved by some government agency before they are refundable or even allowed to be used?
John Oliver did a segment on this. Medical devices do not have to be proven to be effective before they can be used.
https://www.youtube.com/watch?... [youtube.com]
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If proven true in a trial... (Score:5, Insightful)
Those found complicit ought to be charged for each fake implant, and not as
one count of conspiracy to commit wire fraud and health care fraud, and one count of healthcare fraud.
Punishment for these money grabs for charlatan medical devices or treatment should be much stiffer than white collar crimes.
Like the sale or loss of personal information by greedy or reckless companies, the number of offenses will not begin to slow until we haver a beheading or two.
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It's almost as if there's a two-tiered system of justice for the Haves and the Have-nots. ;^)
Collapsing the economy, poisoning the ground water, implanting harmless or deadly medical devices... Somehow, hiding behind the skirts of an incorporated entity protects the individual involved, no matter how evil the act.
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Fraud is criminal, whether by individual or a company. It's just harder with companies - who do you target, the CEO, the engineer that worked on it, the sales people, the janitors? Plausible deniability at all levels, making it a tough nut to prosecute criminally.
Though there really should be more perp walks with CEOs and presidents and vice presidents.
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Fraud is criminal, whether by individual or a company. It's just harder with companies - who do you target, the CEO, the engineer that worked on it, the sales people, the janitors? Plausible deniability at all levels, making it a tough nut to prosecute criminally.
A huge portion of the difficulty is the will to actually hold anyone accountable. To answer, yes the engineers if they worked for a biotech company selling implants and they fraudulently pass off a chunk of plastic. I can understand being given no choice by management and fearing for their financial safety, if that turns up in discovery, would lessen things a bit but there is no actual engineer stupid enough to be oblivious to what they are doing so yes obviously guilty. The sales people could be unknowi
don't waste your money on plastic (Score:2)
Oh.. Don't believe in special magic tvs? No problem. Look up MedBeds. Oh yeah. Alien technology that you talk to or just think about your medical problem and it fixes it !! Just like that !! Honestly, look up medbeds for shits & giggles. It's worth
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you can now pay 10s of thousands of dollars for light therapy. I can't recall exactly what they call it, but It's a TV that displays "special" colors or something. Static. You stare at it and it fixes you.
Hmm, interesting but I’m looking for something that will irradiate my testicles with more light than a pellet fusion reactor. A testis toaster if you will. Can I get one of those?
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Press the button and all your dreams will come true *
*some restrictions apply
<button now leads you thru a thorough personal information rape, another button to be on a waiting list, and a $10,000 deposit... in six months we think it will be ready in around six months from then, but it's definitely worth is to irradiate your testicles, surely you agree>
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and against doctors advice mind you, but for some reason it’s not working and I wanted to try the stronger social media kind. It helped and the shakes stopped for now.
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Snag here is that these are never claimed outright to be medical devices. Any FDA oversight is about whether these are harmful when used or not, and any fraudulent oversight is another department, probably an underfunded one.
This is the same reason why many supplements have less strict oversight, because they're not marketed as cures. So you get all sorts of must-have supplements that have no evidence of efficacy and no guidelines on proper dosage, etc. Same with magnets in your insoles and other clearly
So Science education of MDs is really _that_ bad? (Score:2)
Because it is very obvious what is in there if you cut something and that a shorter Antenna will not work as well or not at all is also very obvious. At least to anybody with a reasonable science education. I would have expected one of the first 5 surgeons or so to get suspicious and have the cut-off length looked at by an EE. Instead, apparently nothing for a long time. Or do I have this wrong and the scam could run long because of delays in doing something about it after it was known to be a scam? The sto
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Because it is very obvious what is in there if you cut something and that a shorter Antenna will not work as well or not at all is also very obvious.
Someone please tell this to phone manufacturers. They have been coasting on receiver sensitivity and lowering the noise floor instead of having respectable antennas for almost two decades.
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Because it is very obvious what is in there if you cut something and that a shorter Antenna will not work as well or not at all is also very obvious. At least to anybody with a reasonable science education. I would have expected one of the first 5 surgeons or so to get suspicious and have the cut-off length looked at by an EE. Instead, apparently nothing for a long time. Or do I have this wrong and the scam could run long because of delays in doing something about it after it was known to be a scam? The story does not say how this was discovered.
Obvious in retrospect. But if you're the manufacturer I'm sure there's a lot of BS explanations you could come up with where even an EE would think "sure, that might work" or even "ok, it will lose some reception but it's probably still enough".
Of course, if an EE actually had a device to look at the jig would be up, or if someone was looking at the device with a critical eye. But generally people don't expect the manufacturer to engage in that level of deception.
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Because it is very obvious what is in there if you cut something and that a shorter Antenna will not work as well or not at all is also very obvious.
They are doctors. They are not electrical engineering experts. They know as much about how RF propagation works from conductive antennas as you do about treating a patent which presents with ${Insert something you definitely don't know about here}. Is your medical education really that bad? Why are you so dumb gweihir! How do you not know *EVERYTHING*!
So (Score:3)
We heard all about how the insurance companies got ripped off, but what about the patients that got sham surgery and the various costs they had to cover?
Crick, crick, crick
Meanwhile, ONE count? Why not a count for each doctor and patient affected?
They are not dummies (Score:2)
They are the prosthetic placebo-version of the homeopathic sugar-pills.
Found in a Pit with Too Few Airholes (Score:2)
That's an act of mass assault. (Score:1)
The perps should be killed. The US horrifically over-punishes crimes of passion and crimes without victims, while white collar criminals know their odds of walking are excellent.
We aren't hurting the right humans. Premeditation is a thoughtful act which generally considers deterrence. If medical scammers were executed the rest would be deterred and nothing of value would be lost. Only good human life is precious and worth any number of bad lives to defend.
Erm, and homeopathy?! (Score:1)
People use it to "treat" their CHILDREN!
Instead of actual healthcare that actually DOES SOMETHING!
Time to ban ALL quack shit.
Placebo effect (Score:2)
And I'll be 30% of the patients who got the plastic felt relief. Of course, now that the FBI has pulled back the curtain to reveal the wizard, those 30% are going to start feeling pain again so maybe they could sue the FBI.
Tin-foilers were right! (Score:2)
Gill Bates is planting 5G chips into patients to track them, change their gender, and inject them with wokeness- and socialism-inducing LSD!
Raid the Capitol in Buffalo garb to stop this now!!!