JOHN DANKOSKY: This is Science Friday. I’m John Dankosky.

Medical devices come in a wide variety, insulin pumps for diabetes, CPAP machines for sleep apnea, or high-tech implants in your retina. The Argus II is an eye implant designed to help blind people, or those with other visual impairments, see in a limited but useful way. Since it was approved by the FDA for a genetic condition called retinitis pigmentosa, it’s been implanted in more than 350 legally blind patients around the world.

But what happens when the company that makes your specialized computer-programmed medical implant goes bankrupt, or merges with another company whose focus is not eye implants?

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– They said we will give you lifetime support. Of course, after you’ve been disabled for a while and had to use any equipment that’s designed for the disabled, you learn that lifetime support means the life of the company making the promise, not the life of the product or the life of the person who’s using it.

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JOHN DANKOSKY: That’s Ross Doerr. He received his Argus II from a company called Second Sight. An investigation by the publication IEEE Spectrum explores the tricky ethical issues of corporate responsibility for patients. And it introduced us to Ross and others who are left wondering, what will happen if they need help with a device that they use to see?

The reporters who broke the story are with me today. Eliza Strickland is a Senior Editor at IEEE Spectrum. She’s based in Western Massachusetts. And Mark Harris is a freelance investigative technology journalist. He joins us from Seattle.

Eliza and Mark, thanks so much for this reporting, and welcome to Science Friday.

ELIZA STRICKLAND: Thanks, John.

MARK HARRIS: Great to be here.

JOHN DANKOSKY: Eliza, let me start with you, and help us unpack this story just a bit more. What exactly was this company offering people?

ELIZA STRICKLAND: So Second Sight’s Bionic Vision System started with a souped-up pair of sunglasses, basically, that had a little video camera just over the bridge of the nose. That video camera streamed video to a video processing unit, which converted this rich signal from the world into a very simple pattern of just 60 pixels. That pattern then went back to the glasses, where there’s a transmitter. And from the transmitter, it was beamed into the implant in the eye.

So the patterns that were generated by the video processing unit used those electrodes to stimulate the eye many times each second, and created a very simplified version of the world in black and white and gray, which the person could perceive. The signal went up the optic nerve to the brain.

JOHN DANKOSKY: Mark, do we know how many people have one of these implanted right now?

MARK HARRIS: Yeah, we know that about– well, over 350 people were implanted with them since the device was first approved. Now, we don’t know how many people have them today. Some of those people certainly have had their device just taken out of the eye after it either failed or they failed to develop the vision that they wanted or expected.

JOHN DANKOSKY: We have one of the people who received this Argus II implant with us. His name is Terry Byland. Terry, welcome to Science Friday. Thanks so much for joining us.

TERRY BYLAND: Thank you for having me.

JOHN DANKOSKY: You actually have the Argus I model implanted in one eye and the Argus II model in the other. Eliza has said that it’s actually a fairly simple black-and-white image. You can explain it certainly better than we can. What does it look like in your vision?

TERRY BYLAND: With the Argus II, I was able to see people’s arm movements, head movements. The further away I was from the person I was looking at, the more I could see of them. The closer you get– it’s like anything else, you know, you get close to somebody, you see less and less of them, even with normal vision. And so that was a big thing for me.

It’s also based on contrast. And in other words, if you’re looking at something that’s got two different colors, say if you’re looking at a building, and it basically will help you determine where the windows are or the doors are, that sort of thing. But here again, it depends. It really depends on how much contrast you’re looking at.

JOHN DANKOSKY: Yeah, we spoke with another one of the patients of Second Sight, Linda Kirk. She explained how just a little bit of vision could go a long way for her daily life, especially her confidence in navigating the world safely.

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– I don’t care if it shows me where the window is in my house, because I know where my windows are. I don’t care if it shows me where the plate is on the table, because I know– I know my table and my plate. What I would really like to have done was to see the white lines on the side of the road and the white lines for crossing the street at a crosswalk. I said, that would be a great benefit if I get that.

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JOHN DANKOSKY: Terry, how exactly did the Argus II change things that you were able to do? Did it make the quality of your life better?

TERRY BYLAND: Oh, yeah, it allowed me to be more independent, in some ways. You mentioned the painted white stripes at the crosswalk. So that’s a big help. Otherwise, without that, you wouldn’t really know if you’re staying inside the crosswalk or not. So with that in mind, you can get across the street pretty quick. And so that there is a big thing as far as mobility goes.

JOHN DANKOSKY: We did talk with a patient, Barbara Campbell, whose implant did stop working suddenly back in 2013, and it never worked again. You mentioned, Mark, that this didn’t work so well for some people. I don’t know if you can talk us through the difficulties that some patients had with the device.

MARK HARRIS: So this device did have a number of different failures for different people. Sometimes it really just irritated the eye. People had retinal detachment and other sort of injuries to the eye. Other people had infections or other sort of medical issues with the eye that the device exacerbated. And there were some people, the device actually failed. So perhaps it fails to do the communication, where it was receiving the information from the wireless unit, or the external units could obviously fail as well. The sunglasses with the camera, the video processing unit could fail.

And some of those were easier to fix than others, right? It’s relatively easy to fix the external units, a new pair of glasses or a new video processing unit. It’s much, much more difficult, in fact, it’s impossible, to repair the device on the eye. Really, the option is to have it explanted, taken out.

ELIZA STRICKLAND: One thing to note is that patients were all told they were going to get upgrades. That the vision was quite crude, but it was just a beginning. The company had talked about a lot of different improvements, cameras, better processing, ways to use a software that would give people radically more precise vision. And none of those upgrades ever came.

JOHN DANKOSKY: This sounds like an awful lot of technology that we all rely on on a regular basis. But when it comes to your actual vision, it’s incredibly important.

Now, Eliza, what happened to this company? They’ve promised all these things to folks like Terry. What has happened to Second Sight?

ELIZA STRICKLAND: Well, in 2018, they began a trial of a new technology, a brain implant, called the Orion. So if they do a brain implant, they can offer it to people who have damaged optic nerves, who have like physically damaged eyes. And they saw that as the way forward.

But in 2019, the company then sent a letter to users of the Argus II retinal implants, saying that they were no longer going to be making this technology.

And Mark could say a bit more, I believe, about what they promised at the time. And also Terry, of course, can say what they promised and what they did or did not deliver.

MARK HARRIS: That was a really interesting letter. Because it said that– it promised that the level of support would not change. That it would be ongoing for years to come. And that there would be a full team of these customer care and rehabilitation specialists to help people continuing to have issues or continuing– or still in the learning path to getting to grips with their new implant. And they also said that they’d taken all measures to ensure that the future supply needs for the device would be met as well.

So they really promised that, OK, perhaps your device is becoming obsolete. But don’t worry, we’re here for you for the foreseeable future. That was in July of 2019. And then, in March of 2020, basically, the company ran out of money. They laid off the vast majority of their staff, most of their engineers and rehabilitation specialists. And they sold– they sold pretty much everything, all their technical equipment, their lab equipment, they sold their laptops. They sold their shelves. This company was really in dire straits.

And they didn’t tell the customers. They didn’t tell their users. They didn’t tell people with the Argus implant that this was happening. The first that some people found out about it was when they had a medical issue, and needed to contact the company, and the company simply wasn’t picking up the phone.

JOHN DANKOSKY: Terry, what was your experience around this time? Were you promised upgrades or something that you weren’t getting, and then you find out, oh, my goodness, this company that’s promised me so much isn’t here anymore?

TERRY BYLAND: Yeah, in 2018, I was at Second Sight here in Sylmar, California, and went through a five-day deal, where they had me to go back and forth every day, trying out this new software. So after that happened, I really didn’t get too many phone calls to come down to Second Sight for further testing. And I was just kind of wondering, you know, what’s going on here? Like anybody else, I mean, you get a taste of something, you want to be able to see more.

It was really baffling to me, because I didn’t get any calls. I didn’t get any phone calls or anything, or letters or anything like that, about anything. And then, finally, I just waited and waited, and one day I just said, well, the heck with this, so I called them.

One thing I wanted to say is that I’ve dealt with these people at Second Sight since 2005. And I know how hard they work at their craft, the engineers, the scientists, the technicians, and so on and so forth. So I mean, they tried their best to do what they could do with it. And when the funding dried up, well, everything else went south.

JOHN DANKOSKY: It’s heartbreaking to hear that. Because as you say, how much work they put it into it, but also how it might work you put into it. I mean, I think, from a journalist’s standpoint, from just a human standpoint, it seems obvious that a company like this would owe it to the patients with this implant, but legally what do they have to do? What are you expected to do in terms of support for a device that’s so specialized and so technically sophisticated?

MARK HARRIS: So you have to remember that all of these users also had a really professional medical team, their eye doctor that was actually doing the implanting. The company itself had responsibility to produce a functioning, safe and effective device. Now, the FDA had licensed that device and approved it and said they had a good device.

Now, when it comes in terms of support, yeah, there did seem to be a mismatch between what the patients expected and what was delivered. And one of the reports– the anonymous report from a person whose device had malfunctioned, said that they had got this device, assuming they were going to have it forever. But what it actually turned out was that they felt the device failed within a number of years.

And legally, it’s unclear whose responsibility it was. But it was definitely a mismatch between what the patients expected and what the company delivered.

JOHN DANKOSKY: Eliza, what has the company told you about their plans to provide resources and care for former patients?

ELIZA STRICKLAND: They declined to be interviewed. They did respond to our fact check questions. But they did– Second Sight did not say anything specifically about what it could do for its patients. The most that they said was that they had a limited supply of external equipment, sunglasses and video processing units, that they could make available to people who needed them if their units broke.

After we started our reporting, they then sent out a letter to all their users, explaining that they did have some spare equipment. Before our reporting started, as far as I know, most of the users had no idea.

Until that stockpile runs out, people do have some possibility of replacing the externals. But there’s really no possibility of repairing or replacing the actual implants in the retinas.

JOHN DANKOSKY: I’m John Dankosky, and this is Science Friday, from WNYC Studios.

Aside from the problems that so many patients will have with upgrading their equipment, their implants, and what will happen if their equipment stops working, there’s also some other problems that have been presented to patients. Here’s Ross Doerr again. He’s talking about the support that he didn’t get recently when he needed to know if it was safe to get medical tests with a piece of metal that’s been implanted in his eye.

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– To be able to get an X-ray from my dentist last year, I mounted a campaign of telephone calls and emails– will you please call my dentist? They are frightened of giving me an X-ray, because they’re not sure how it’ll be.

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JOHN DANKOSKY: And I should note that Ross was also unable to find out if he could safely get an MRI when his doctor wanted to investigate the possibility of a brain tumor.

And Mark, from all the patients that you’ve talked to, this is another very serious concern. It’s not just about whether or not this equipment works or can be supported, but people in doctors’ offices and dentists’ offices don’t exactly know how to deal with a retinal implant, and there’s no one to call.

MARK HARRIS: That’s right. Right now, the only solution these users have is for their medical staff to talk to their eye doctor. But those doctors, of course, are not expert on the implant itself. So while they are a great backup, they’re not the absolute Encyclopedia Britannica on what is going wrong with that implant.

And so there is always the possibility, especially if people need care urgently, or especially if they need an involved medical procedure involving their vision or their head, that there is going to be a gap there of treatment, which obviously no one would like.

JOHN DANKOSKY: You’ve reported that Second Sight may be merging with another company, called Nano Precision Medical. Has that company said anything to you about what they’re going to be doing for patients with these Argus implants?

MARK HARRIS: We did get to speak with the CEO of Nano Precision Medical. He said the right things. He said he’s listening. He’s keen not to repeat mistakes that have been made in the past. And he’s open to maintaining as much support for these Argus users as his new company is capable of. But his new company doesn’t specialize in vision implants.

It’s an exciting company, with a drug implant technology that could help thousands of people. But it’s nothing to do with vision. And so the question really remains is, however much goodwill is there, however much he intends to work to this and to keep these patients supported, how much support is actually going to be there in the real world?

And that’s just really an open question. And we don’t even if the proposed merger will actually complete. So it’s still very much up in the air what’s going to happen with the Argus units, with the technology itself, and with the support for the patients.

JOHN DANKOSKY: Eliza you mentioned in your reporting that there’s a big effort now toward brain implants. I’m wondering about the kind of accountability structure for companies that implant these complex devices in people’s bodies. When we’re talking about brain implants, it’s a step beyond a retinal implant like we’ve been talking about.

ELIZA STRICKLAND: Right. So Second Sight did try to pivot to this brain implant technology, the Orion technology, which is an implant that goes over the visual cortex. There are currently five people walking around with these implants in their brains. They have good support from their neurosurgeons, of course. Like their neurosurgeon teams are there for them. But it’s very unclear if Second Sight is going to be continuing to develop this technology in light of their financial problems and in light of the merger.

Yeah, I do agree that everything becomes more dire when you’re starting to talk about actually putting technology into the brain. This field is so new that there’s not a great deal of regulation there yet. The brain implants that have been commercialized are mostly from big device companies, like Medtronic, companies that are well-established and not going to go out of business anytime soon. But these smaller companies that are working on some of these really cutting-edge technologies, it’s not really clear what responsibilities they’re going to be held to.

JOHN DANKOSKY: Mark Harris is a freelance investigative technology journalist. He joined us from Seattle today. Eliza Strickland is a Senior Editor at IEEE Spectrum. She’s based in Western Massachusetts. They broke the story about Second Sight and the Argus II implant.

I also want to thank our guest Terry Byland, who has had these implants for a number of years. Terry, thank you so much for your time. Mark and Eliza, thank you so much for your reporting.

TERRY BYLAND: Oh, you’re welcome. Yeah.

ELIZA STRICKLAND: Thanks, John.

MARK HARRIS: Thanks, John.

JOHN DANKOSKY: I also want to thank Second Sight patients Linda Kirk, Ross Doerr, and Barbara Campbell, for speaking to our producer for this story. We’re grateful for your time.

More on Mark and Eliza’s reporting can be found on our website, sciencefriday.com/eyeimplant.

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