A brain implant changed her life. Then it was removed against her will.


“A patient should not have to undergo forcible explantation of a device,” says Nita Farahany, a legal scholar and ethicist at Duke University in North Carolina, who has written a book about neuro rights. 

“If there is evidence that a brain-computer interface could become part of the self of the human being, then it seems that under no condition besides medical necessity should it be allowed for that BCI to be explanted without the consent of the human user,” says Ienca. “If that is constitutive of the person, then you’re basically removing something constitutive of the person against their will.” Ienca likens it to the forced removal of organs, which is forbidden in international law.

Mark Cook, a neurologist who worked on the trial Leggett volunteered for, has sympathy with the company, which he says was “ahead of its time.” “I get a lot of correspondence about this; a lot of people inquiring about how wicked it was,” he says. But Cook feels that outcomes like this are always a possibility in medical trials of drugs and devices. He stresses that it’s important for participants to be fully aware of these possibilities before they take part in such trials.

Ienca and Gilbert, however, think something needs to change. Companies should have insurance that covers the maintenance of devices should volunteers need to keep them beyond the end of a clinical trial, for example. Or perhaps states could intervene and provide the necessary funding.

Burkhart has his own suggestions. “These companies need to have the responsibility of supporting these devices in one way or another,” he says. At minimum, companies should set aside funds that cover ongoing maintenance of the devices and their removal only when the user is ready, he says. 

Burkhart also thinks the industry could do with a set of standards that allow components to be used in multiple devices. Take batteries, for example. It would be easier to replace a battery in one device if the same batteries were used by every company in the field, he points out. Farahany agrees. “A potential solution … is making devices interoperable so that it can be serviced by others over time,” she says.

“These kinds of challenges that we’re now observing for the first time will become more and more common in future,” says Ienca. Several big companies, including Blackrock Neurotech and Precision Neuroscience, are making significant investments in brain implant technologies. And a search for “brain-computer interface” on an online clinical trials registry gives more than 150 results. Burkhart believes around 30 to 35 people have received brain-computer interfaces similar to his.

Leggett has expressed an interest in future trials of brain implants, but her recent stroke will probably render her ineligible for other studies, says Gilbert. Since the trial ended, she has been trying various combinations of medicines to help manage her seizures. She still misses her implant.

“To finally switch off my device was the beginning of a mourning period for me,” she told Gilbert. “A loss—a feeling like I’d lost something precious and dear to me that could never be replaced. It was a part of me.”


Source : https://www.technologyreview.com/2023/05/25/1073634/brain-implant-removed-against-her-will/

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