For those not reading the story, which appears to be many, the company that services the implant went bankrupt. The implant was experimental. There exists no one to service it any longer. It will pose a health risk down the road without someone servicing it.
The only thing that forced her to have the implant removed is the fact that it would eventually lead to her untimely death if it remained in with no one to take care of the device.
Even if her death is guaranteed by leaving it in (and I’m not sure it is without more information), does that make it ethical to remove? Perhaps the patient would prefer a shorter life with greater quality in regards to her seizures. After all, don’t we allow and accept cancer patients to forgo treatment and enjoy the time they have left?
Frankly the articles I’ve found all use a mix of really weird language. In some places it says she was ‘advised’ to remove it by doctors, which makes a lot of sense. In others they talk about finances and purchasing the implant from the company.
My guess is that it was a combination of factors and while she ultimately did not want to give up the device despite being urged by doctors (she accepted the risk of leaving it in), but she was robbed of the possibility by capitalism and the fact that the company was forced to liquidate assets as terms of going bankrupt or being bought by another company. But we might have to wait for a court case or proper reporting to find out.
I hope we are able to enshrine some rights over forced explantation in the future. As soon as a device is implanted in you, you should own it 100%, no matter the cost of the device. To encourage making this possible even for extremely expensive devices, we should probably offer huge write offs or some other incentive to these companies lest they decide to restrict their purchase to only rich clients.
Owning the device doesn’t help if it requires regular maintenance and there’s nobody able to do it anymore.
I mean, we should protect against that too by requiring a certain level of service. But at the very least they need to own the device and have the right to leave the device in, even if it would fail or potentially cause them harm. I pointed that out because it sounds like they wanted to leave it in and not listen to the doctors advice to remove it, but could not for some reason. The only reason I can imagine would involve someone paying for the surgery to remove it against her will is one in which she does not own the device and the alternative is being burdened with a massive debt to pay off the device.
How do you require a certain level of service when the company that made it goes out of business? Or when employees with essential knowledge leave the company? I’ve been working in software for a long time, and everywhere I’ve worked, losing someone knowledgeable about a product is a big blow to future development because a lot of important knowledge is only in their head, leaving future maintainers to do a lot of reverse engineering. Requiring documentation wouldn’t work because any company that had strict enough requirements would have a very hard time hiring engineers willing to spend so much time documenting every little thing.
You require them legally to budget and plan these things and give them harsh penalties if they fail. That they need to set aside money in a way that it can’t be touched if they go under. You’ll likely need to hire teams at the government to help fill gaps and coordinate.
I don’t think you have any idea how much money you’re talking about. The fact that you’re proposing it in the context of an experimental device that was probably never even marketed is just deranged. We’d still be stuck with 1950s-level technology if you had your way because nobody could afford to develop any new products that can’t be made in a basic machine shop.
True ownership would imply also having access to the code and documentation, a third party should be able to maintain it with that.
Code and documentation mean someone could theoretically maintain it, but the average consumer could not. You need someone with the knowledge, time, equipment, etc. to think it’s worth their while to learn how to maintain it. In the case of a physical device that also means the ability to manufacture spare parts, some of which could be very exotic. For an experimental medical device, it also includes detailed medical knowledge that most doctors don’t have. And actually working on it means being willing to take the risk of killing someone if you screw up.
I doubt the person in the article would be helped in the slightest by receiving code and documentation.
Yeah I don’t think this is a coding issue. This is something on your brain and if the hardware requires maintenance you better have qualified surgeons that know and understand the device. Of that’s no longer possible because the producer no longer exists then it’s maybe not a bad idea to have it removed, depending on some factors of course like “how long does she have left to live” and “how much does she suffer.eithout the device”.
Why would a medical device exist such that even with documentation a surgeon unaffiliated with the company cannot safely interact with it? You would think it would be a design priority for any maintenance to be straightforward and with clear instructions. I have a hard time imagining that the problem here is anything other than proprietary information being tied up in red tape.
FDA approval is contingent on so many factors that even if it was entirely open source, including all hardware design and the instructions for assembly, maintenance, and manufature it would be entirely plausible for it to lose approval if the company responsible for continued development went bankrupt.
Without approval, no reputable surgeon will do anything beyond remove it.
A device not having a clear and unambiguously documented path for addressing defects found in the future is more than sufficient reason to lose approval.
Oh I agree with you, but that requires laws being written correctly. Healthcare being what it is currently in the USA, I very much believe that the women was better off with the device removed.
One of the articles suggests that the device was removed because the batteries were no longer available and nearing end of life.
Regardless, a surgeon is only going to maintain devices approved by the FDA or cleared for investigational use. If the company goes bankrupt then both are no longer the case.
Sounds like an FDA and battery standards problem then.
There’s another article that explains that it wasn’t just the battery. After the company went under, there was nobody who could provide support for the product in the event of malfunction. Removal was recommended as the safest course.
This isn’t an “FDA problem”. The device was investigational, which means it did not have final FDA approval. Consequently, there is no guarantee that a surgeon would have the knowledge to maintain it. Surgeons are not expected to be familiar with every experimental device, in fact most surgeons will never touch any experimental device.
And no, surgeons aren’t just going to read a bunch of documentation to get up to speed. Typically, when a new product launches the manufacturer will send their technical representatives into the operating room to help troubleshoot any issues.
This, right here, is really important. We already have otherwise useful things being bricked because the software is no longer updated, or worse, the company goes bankrupt. If that’s our future with brain implants, that’s going to be a big problem.
Doctors remove unsafe implants and/or replace them with safer versions all the time, including devices like deep brain stimulators. I don’t see why you consider this to be a big problem.
Because every surgery has risks, including simple ones. In this case, there would be no direct medical reason to do so.
There was a medical reason, the device was considered unsafe. Any experimental device is considered unsafe without monitoring, and monitoring was no longer available. That’s why she chose to have it removed.
Anyone who signs up for a clinical trial knows that their treatment can be discontinued at any time, even if it is helping them. For example, if an implant is helping you but is found to be harming other people, it may be considered unsafe and you may be advised to remove it. In fact, a different article suggested that other patients were experiencing adverse effects from this experimental implant. This might even be why the company couldn’t get their product approved and eventually lost funding.
she accepted the risk of leaving it in
It doesn’t say that. It says she was willing to pay to keep it in, which means she was willing to pay for long-term maintenance. But there was nobody willing to provide maintenance, because the company dissolved. That is why she was advised to remove the device.
the company was forced to liquidate assets
Implants generally go in the garbage after removal.
Implants that failed to gain FDA approval definitely go in the garbage after removal. Nobody else wants them, in fact the company will end up having to pay for proper disposal of medical waste.
It doesn’t say that.
Yes I very clearly stated what my *guess *was. Nothing says enough to determine what truly happened here. As someone who works in the medical field, I’m making an educated guess based on my knowledge of how medical devices, elective surgeries, and governing bodies work.
She was advised to remove it.
I think “forced” is doing a lot of heavy lifting here. People use it to refer to unpleasant decisions, like “I was forced to leave New York City after I lost my job”.
Others have speculated that she may have been denied health insurance coverage unless she had it removed. That’s not much of a choice when you’re an old disabled woman.
In the US, you can’t be denied health insurance based on your medical history. Thanks, Obama! No really, thank you.
She’s Australian. They have universal healthcare, so @MadMenace’s theory probably isn’t the case here.
I somehow doubt elective, experimental electronic implants are classified as a “pre-existing condition.”
Classify them however you want, they have nothing to do with your eligibility for health insurance.
In fact, ACA health plans must enroll anyone who wants to enroll. They cannot decline an individual renewal. A premium can only be adjusted according to age and tobacco use. And they cannot charge old people more than three times what they charge young people.
Sure, but insurance companies regularly deny claims for any reason they can find.
It sits on the edge of the concept of informed consent in the realm of things like SaaS and copyright. Obviously doctors wouldn’t hold her down and pull it out, but obviously it probably was not useful to leave in. I wonder if there was a contract stating it had to be removed upon demand, like at the end of a trial or the bankruptcy that occurred. It’s something that we’re going to likely see in the future, as medical technology starts using computers to actively treat disorders.
For those not reading the story, which appears to be many, the company that services the implant went bankrupt. The implant was experimental. There exists no one to service it any longer. It will pose a health risk down the road without someone servicing it.
The story doesn’t directly say that’s why it had to be removed (and she talks about wanting to buy it). I found another source that explains that the device came with a three-year battery life.
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This story was described more accurately by The New Yorker. No, they did not do anything without her consent.
For three years after her operation, Leggett lived happily with her device. But in 2013 her neurologist gave her some bad news. NeuroVista had run out of funding and ceased operations. Leggett’s neural device would have to come out.
Leggett felt grateful that everyone involved was sympathetic to her plight. They let her keep the implant as long as possible. But the demise of NeuroVista—after spending seventy million dollars to develop the technology and conduct the trial, it struggled to find further investors—made removal inevitable. If the battery ran out, or a lead broke, or the site of implantation became infected, the company would no longer be there to provide support. She remembered a solemn drive to Melbourne for the surgery, and then coming back home without the device. It felt as if she had left a part of herself behind.
These days, when she gets a funny, flip-floppy feeling inside, she takes anti-seizure medication. She’s not always sure. Sometimes she gets her husband to weigh in. He says, “Go with your first instinct,” and usually she takes a pill. She is now seizure-free.
The article also suggests that other patients had problems with the device, which may have contributed to the failure of the clinical trial and recommendation for removal.
Yah. My BS counter is clicking quite a lot with this one.
You can’t force someone into surgery against their will. No hospital or doctor would do that. It would be a major crime. The surgeon, anesthesiologist, who knows how many others, would go to prison! That kind of crime.
The company may have coerced her, with threats of lawsuits. But that’s very different. And the article completely avoids any mention of exactly how she was forced to go through with it. If that information was included, it would only make the company look worse. I can’t think of why it would be left out, given the narrative they’re creating here.There is a lot missing from this story.
I’d bet she took a some kind of settlement that included payment and a form of NDA.People being contractually obligated to undergo medically unnecessary surgery is still an intolerable atrocity.
The company may have coerced her, with threats
in other words - forced
No. Force is when there are no threats. The “or else” goes away. There are no other options. It’s only “this is happening”.
If a toddler is refusing to wear their shoes. Taking away their toys isn’t force. It’s coercion. Force would be, grabbing their leg and putting their shoe on, no matter how much they scream or cry.
Forcing an adult to do something, is a very extreme action. Reserved exclusively for police, and even they have limits. Even the police can’t force you to have surgery.
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Forcing someone, is a massive escalation. It’s often the difference between physical violence and not.
I hope it never happens to you. It’s a very different kind of experience.
Your bullshit counter is broken, Steven
here’s the link from MIT technology review : https://www.technologyreview.com/2023/05/25/1073634/brain-implant-removed-against-her-will/
here’s their imprimatur from the MIT itself : https://news.mit.edu/1995/tech-review-0201
I’d have that clicking checked out
That has no additional information. I’m not saying the story is made up. Just that it leaves out a lot of important details about what exact mechanism was used to “force” her.
If she’s insured, she would lose her insurance, if her medical care is being provided at no cost from the state through medicare she would lose that, so, they really leave the person no choice. Show up and have this fucking thing removed, or lose any future medical care whatsoever. I mean, it’s still a choice, sure. No one forces anyone to eat or drink either, Steve.
That’s speculation. They seem like reasonable possibilities, but we don’t know because it wasn’t explained.
At worse, all that is coercion. Well mostly just natural consequences really. Still not force.People can absolutely be forced to eat or drink. It’s been done in the past, when inmates go on a hunger strike. Half a dozen people strap them down, force a feeding tube down their throats. If lucky, they’d be sedated first.
They aren’t reasonable possibilities, because Medicare covers everyone over 65 regardless of their medical history and ACA health insurance plans are required to enroll all applicants regardless of age or medical history.
The latter can raise your premium if you smoke tobacco. That’s literally the only power of “coercion” they have available. All your other choices are off-limits.
I think you and @Steve@communick.news (and @downpunxx@kbin.social ) might have missed the part where the woman is Australian and this whole thing took place in Australia, where there is universal healthcare.
I did miss that.
Seems there are fewer reasons for her to give it up.
In the US, you can’t lose your health insurance based on your medical history.
Pretty much the only way for an individual to lose their health insurance is by leaving their employer, if they have employer-provided insurance.
Non-employer-provided plans are required to enroll anyone who wants enroll.
The articles point out the company went bankrupt and her doctors advised her to remove the implant. It says she was willing to pay to keep it, and suggests this could have been avoided if another company could have taken over device maintainance.
All of which suggests that the device was removed because it could no longer be maintained, despite her willingness to pay.
Insurance can totally refuse future medical care until the implant is removed, especially if leaving it in poses a serious risk. Perfectly valid way to get her to have it removed without physically forcing someone to undergo surgery.
No, they can’t do that. Insurance can’t just randomly decide to change all of their contracts on a whim.
Insurance companies are shitty, and dealing with them sucks, but there are legal rules they have to follow, and just deciding unilaterally to not cover healthcare isn’t an option for a paying customer.
For profit companies and medicine cannot co-exist.
So while governments can bailout big companies that are able to serve their greater interests, medical companies with cases like this and the bionic-eye one slip away without any kind of intervention?
We have multi-million-dollar VC funds for an app and this shit is allowed to happen.
🤖 I’m a bot that provides automatic summaries for articles:
Click here to see the summary
A woman whose epilepsy was greatly improved by an experimental brain implant was devastated when, just two years after getting it, she was forced to have it removed due to the company that made it going bankrupt.
Leggett was, as a recent paper in the journal Brain Stimulation about her situation explains, 49 when she was recruited for the trial, though she’d suffered from epilepsy since she was just three years old.
Leggett, who declined to be interviewed by the Tech Review after a recent stroke, also developed a symbiotic relationship with the implant, and told the researchers behind the Brain Stimulation paper that she and the BCI “became one.”
In fact, it calls to mind a similar incident last year in which the manufacturer of a bionic eye decided the units were obsolete, leading patients who’d had them implanted to lose their vision again.
It sounds like dystopian fiction that biotech companies could play takesie-backsies with patients’ implants, in other words, but the reality is we’ve already crossed into that world.
And if devices such as Leggett’s BCI can, as she suggested to researchers over the years, become part of a person, then their removal “represents a form of modification of the self,” Ienca said, and he and his coauthors are arguing that there need to be updated patients’ rights when it comes to these sorts of outcomes.
Saved 62% of original text.
Formatting tip: It would be great if there was a line break after you explain that you’re a bot and before your summary starts.
In my app and the web it appears to have a line break and I also have to tap through a spoiler tag to view the summary.
Weird. Maybe there’s something incompatible with wefwef then. Mine shows the intro statement and then the article starts immediately after the “click here” text (which I can’t actually click lol).
Edit: So I just checked on Memmy and it comes up with the “I am a bot…” and the “click here” works, but after clicking it it’ll only show the first paragraph of the summary… 🤷♂️
One step closer to Repo Men becoming reality.
Zydrate Anatomy is an absolute banger though.
yours is not the Repo Man I think of when I think of Repo Man
I’m guessing the patients were required beforehand to sign forms consenting to the device being taken out in the event of ___________ (in this case, the company going under). Because otherwise I don’t understand how it’d be legal to force someone to have brain surgery against their will.
But if the company can’t continue maintenance and support for the device, why not have her sign new forms exempting them from liability and just let her keep it? Is potential liability not the only limiting factor here? And would this be ethical?
You can always legally revoke consent for medical interventions, too.
Or, at least, that’s my understanding as a layman.
why not just let her keep it
It could also be for patenting reasons.
Every implant legal agreement must include a clause allowing the patient to keep the device in the event of company bankruptcy.
