What happens to users of cutting-edge implants when the only company that makes the technology runs out of money? That’s the question we set out to answer during a year-long investigation of the Argus II retinal implant, manufactured by a California company called Second Sight Medical Products. The investigation was published by IEEE Spectrum in February and covered in a recent Science Friday broadcast.
Strickland had first written for Spectrum about the company back in 2011, lauding the development of a revolutionary eye implant that restored a crude kind of artificial vision to blind people involved in Second Sight’s clinical trials. That article featured a New Yorker named Barbara Campbell, who had been completely blind since her 30s because of a genetic condition called retinitis pigmentosa, but who could then make out rough shapes, figures and lights. The retinal implant connected wirelessly to a pair of sunglasses housing a low-resolution video camera. In 2013, the Argus II system was the first visual prosthesis to be approved by the FDA.
As the Argus II rolled out in the United States and around the world, many more such stories were written, typically showing users delighted to regain some vision — even if it was only flashes of light and shades of gray. Globally, over 350 people would ultimately have an Argus II implanted.
Late in 2020, Strickland revisited Second Sight to write a blog post about its latest project: a brain implant that stimulates the user’s visual cortex directly, potentially opening up its prosthetic system to a much wider group of people with vision challenges. Tucked away in that post were a few lines noting that the company had suspended production of the Argus II device and had recently suffered financial difficulties, nearly going out of business in early 2020. Strickland tried to contact the company for a status update, but didn’t get a response to her emails and phone calls.
All of this got Strickland wondering what had happened to those delighted users of Second Sight’s original retinal implant. Were they still receiving support and upgrades? And what did the future hold for them? Strickland approached Harris, a long-time Spectrum contributing editor, and suggested a collaboration.
We began by trying to identify and contact as many Argus II users as possible, starting from the glowing news stories that had followed many implants and which often included patient names. Using public data sources and social media, we tracked down nearly a dozen users, including Barbara Campbell, who Strickland had last spoken with a decade earlier.
A handful were willing to talk with us on the record, and the stories they told were both inspirational and shocking. One had reluctantly given up on using the implant after getting only disappointing results. Another Argus II user had such a positive experience he got a second device in his other eye — making him the only person on earth with two such bionic implants. And Barbara Campbell herself was back in the dark after her implant had unexpectedly and permanently failed in 2013 while she was changing subway trains.
All users had been told that Second Sight was working on upgrades for their implants, and some had participated in medical tests and trials to help develop next-gen software and hardware. They were all disappointed in 2019 when Second Sight told them it was discontinuing the Argus II to focus on its new brain implant, Orion. But they felt reassured when the company promised to stockpile Argus II supplies and maintain its current level of support “for years to come.”
However, eight months later, none of the Argus II patients were informed when Second Sight ran out of money, laid off most of its staff and essentially stopped operating. It was not even responding to urgent medical queries, we discovered. One user told a harrowing tale of requiring an MRI to check for a brain tumor, but because the company had essentially gone dark, he was unable to get an answer about whether such a procedure would be safe.
We found the online auction site that had sold almost all of the company’s physical assets, from the latest medical equipment down to laptops and shelves. Using LinkedIn, we identified ex-employees of Second Sight and approached them for interviews. One veteran engineer gave us a good picture of the company’s operations in its final months and confirmed accounts that we had heard secondhand from users.
We wanted to understand what had gone wrong with this once-promising company and why it had pulled the plug on the Argus II. The company’s leadership declined our interview requests (though they did eventually answer some fact-checking questions via email). However, Strickland had interviewed one of the company’s founders in years past. That co-founder, Robert Greenberg, was no longer with the company and agreed to speak with Strickland. In his telling, the trailblazing company had discovered just how challenging the trail to commercial profitability was. We also spoke with a handful of doctors who had implanted either the FDA-approved retinal implant or the brain implant that was undergoing clinical trials. Most still thought the technology held promise and had been taken by surprise by the company’s sudden downsize.
We also wanted as much detail as possible about the viability and safety of the device. The FDA had approved the Argus II and was in possession of a long-term post-approval study that followed 30 people with the implant. We filed a FOIA request for that in May 2021, but it has yet to be fulfilled. However, the agency also maintains a database called MAUDE that contains reports of problems with medical devices. We mined MAUDE for additional anecdotes and performed basic analysis of the reported medical problems relating to the Argus II. The voluntary and user-generated nature of those reports means the data can contain inaccuracies and repetitions, so we included this information in our story with caveats. Closer to publication, the FDA did provide answers to a few fact-checking questions relating to MAUDE data.
We also made use of Securities and Exchange Commission filings for Second Sight, which is a publicly-traded company. An exhaustive reading of these documents revealed developments in the company’s clinical trial of its brain implant — and showed the extent of its financial straits. Up until shortly before publication, this information informed our skepticism about Second Sight’s ability to ever bring its brain implant to market.
Then came the breaking news. We were following mentions of the company in news channels and on social media and learned about a proposed merger of Second Sight just days before the article went to press. We swiftly secured an interview with the new CEO of the proposed merged venture and rewrote the story as needed. Sadly, the proposed merger seemed to offer no concrete help to Second Sight’s early adopters. While the new CEO said the right things about supporting users and not repeating the mistakes of the past, he ruled out reviving Argus II sales and didn’t commit to a timeline for commercializing the Orion implant.
Even before our article was published, it did some good. Second Sight’s leadership, aware of our reporting and our outreach to its customers, sent letters to all U.S. users of the Argus II and all the physicians who had done implants. The letters said that Second Sight had a limited inventory of external spare parts (the glasses and a video processing unit) that they’d make available to patients. However, no repairs or replacements were offered for the retinal implants themselves.
The article made a big splash in the science and tech media, with multiple outlets reporting on it. One reporter for the BBC got the CEO of the proposed merged company on the phone; he told her that he was thinking about the issues raised by our article, saying, “I do intend to make this one of our priorities” if the merger goes through.
Such words are nice to hear, but it’s hard to see how they’ll translate into real hope for people waiting for the Orion brain implant, much less action for Argus II users. Second Sight currently doesn’t have the equipment or expert staff to build more implants or accessories. Once the current generation of Argus II implants eventually fail, their users will once more be living in the dark.