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Doctors Remove Woman’s Brain Implant Against Her Will
(futurism.com)
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this post was submitted on 02 Sep 2023
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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.
True ownership would imply also having access to the code and documentation, a third party should be able to maintain it with that.
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.