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ArbitraryValue , (edited )

I suspect they told her the risk of the device killing her or making her life worse was either extremely high, or impossible to judge, and she made the decision on her own to get rid of it.

I also think this was probably what happened, although the article isn’t clear.

To be clear this is a travesty, and the people running the responsible company should face severe consequences

Why do you think so? There’s nothing special about making brain implants which protects a company from going bankrupt. The bankrupt company can neither continue to service the implant nor legally give her the ability to service it herself even if they wanted to.

The FDA won’t let a company that makes medical devices provide anything to patients without proving that it’s safe first. There’s no exception for patients willing to take that risk except in the context of clinical trials that are regulated very strictly. Letting this woman service her own brain implant isn’t just missing official proof of safety; it almost certainly isn’t actually safe.

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