Doctors are concerned about the growing number of people being left with obsolete medical implants inside their bodies, due to the companies behind these devices shutting down or abandoning their products.
Speakers at the Royal Society Neural Interfaces Summit, held in London last��week, have called for medical regulators to take action to ensure such patients receive continuing medical care.
Some of those affected might need the non-functional device to be removed, while others might want it to continue working. “Neurotechnology can provide great benefit to people, but it can be devastating when people lose a therapy and they can be left in a worse state than when they started,” said at University College London.
Advertisement
There are increasing numbers of experimental medical devices being developed that stimulate nerves to treat things like pain and spinal cord injury, as well as a growing list of conditions that involve a major branch of the nervous system called the vagus nerve.
But it is a challenging industry to succeed in, with many companies going bust along the way. In some cases, the product worked well, but couldn’t be successfully commercialised because it cost too much or the market was too small. With no manufacturer, once parts wear out or software needs updating, a device may stop working, leaving people stranded.
“If you’re going to implant a device into someone, your responsibility doesn’t end when you put the implant in. It ends when the patient no longer needs it or passes away,” said at Brighton and Sussex Medical School, speaking at the summit.
While there is no global count of the number of people with a defunct medical device, there have recently been several high-profile cases of this happening.
For instance, about 350 people received the Argus II, an eye implant designed to treat blindness, made by Second Sight Medical Products, based in Los Angeles. While it doesn’t restore sight, the implant gives people a crude impression of light and dark patches in their vision.
But in 2019, the firm discontinued its retinal implant to focus on a different device implanted in the brain, which could help larger numbers of blind people. In 2020, the firm nearly went out of business and most of its staff were let go, including vision rehabilitation therapists who helped customers use the implants.
After refinancing last year, the technology is now owned by a firm called Cortigent, which says it is providing legacy customers with support and new component parts. The firm told 91av: “Cortigent recognises that patient safety is paramount, and that patients who receive medical device implants from companies that undergo reorganizations or face financial difficulties can be at risk of reduced customer service. We support collaborating with the relevant industry stakeholders to develop new ways to minimize this risk.”
Another firm called Autonomic Technologies (ATI), based in San Francisco, made a facial implant for alleviating devastating cluster headaches. ATI closed down in 2019, after implanting about 700 people in Europe with the device.
The stimulator is turned on as needed by holding a controller next to the face, which is powered by an internal battery that isn’t intended to be replaced – instead ATI would provide a new controller unit. A German man called Markus Möllmann-Bohle, who is an electrical engineer, has managed to keep his device working by sourcing the unusual battery type online and changing it himself, according to a .
The technology behind the device is now owned by a US firm called Realeve, which is working to get approval for use in the European Union. “We are exploring options to support existing ATI patients before full approval, but the EU regulations prevent us from providing support for these patients until our new production line is complete and we receive clearance from regional regulatory agencies for each country,” said a Realeve spokesperson.
Speakers at the neural interfaces summit said the industry must consider several measures to help protect people left in this position, including making neurotechnology firms contribute to a global fund that could be used to provide long-term care.
Other options include requiring firms to use open-source software so that any programmer could make adjustments, and agreeing on industry-wide standards so that different device components are compatible, such as is the case already for heart pacemakers.
“If the [US] Food and Drug Administration said ‘this is the standard’, then everyone has to follow that format and everyone can fix it,” said Ekanayake. But at the US contract research organisation MCRA warned that more standardisation could lead to less innovation, for instance, by preventing components from being miniaturised.
Whatever happens, Doherty said developers need to think longer term than they currently do. “We typically design devices to last 10 or 15 years, but people last a lot longer than that.”
