White Coat, Black Art

How safe is your medical device? Even regulators may not really know

Could your hip replacement hurt you? Journalist Jeanne Lenzer explores the medical device industry in her book, The Danger Within Us, and Dr. David Urbach tells us why Canada's device regulators should be doing a better job.
Dennis Fegan with his grandchildren. Fegan's Vagus Nerve Stimulator was implanted to control seizures caused by epilepsy, but it instead stopped his heart. (Catherine Modlin/Submitted by Jeanne Lenzer)

[Originally published on March 17, 2018]

The medical world has caught a severe case of the tech bug.

Cutting-edge medical devices are joining pacemakers, lenses and artificial hips and knees implanted inside millions of patients, and for the most part, they're improving the lives of patients.

But in her book The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It, Jeanne Lenzer details disturbing stories of recalls, hacking, injuries and even deaths related to medical devices that go largely untested and unregulated.

She told White Coat, Black Art host Dr. Brian Goldman that to find the root of this unregulated market in the U.S., one has to go back to 1976 when the Food and Drug Administration (FDA) took control of the medical device industry. 

"At that point there were already a lot of devices on the market and in people's bodies; everything from pacemakers to nerve stimulators and spine implants. So what the FDA did was they said, 'OK, you guys are already all on the market, we will grandfather you in,'" said Lenzer, who has written for BMJ, (formerly the British Medical Journal), New York Times Magazine, The New Republic and other outlets. 

Author and journalist Jeanne Lenzer's new book The Danger Within Us chronicles the untested, unregulated medical device industry. (Submitted by Jeanne Lenzer)

 "To make matters worse, they told companies, 'Now if you want to add new devices you can simply say that your device is similar or substantially equivalent to a device that's already on the market.'"

This approval method means many devices on the market have never been tested on humans, and some have not been proven clinically safe or effective.

Moreover, Lenzer said, it's extremely hard to discover (let alone track) how many devices have been sold or implanted into patients.

"The FDA doesn't require manufacturers to tell them how many people are even implanted with their devices. It's a black hole," Lenzer said.

The surgeon who took his hip out described what he saw as an 'automotive crank case full of dirty oil.' The tissues had turned to black mush.- Jeanne Lenzer

For example, the DePuy metal-on-metal hip implant ended up poisoning some patients, leading to a recall and lawsuits against the maker. 

The metal hips parts grated on one other, releasing chromium and cobalt, causing metallosis. Lenzer described the case of a U.S. surgeon who had to have his own metal-on-metal implant removed. 

"The surgeon who took his hip out described what he saw as an 'automotive crank case full of dirty oil.' The tissues had turned to black mush," Lenzer said, adding that cobalt poisoning can also cause thyroid disorder, heart failure and brain problems. 

If the U.S had a mandatory registry for devices the way Japan, Australia and other countries do, patients who had devices implanted at U.S. hospitals might have been saved from needing a heart transplant after the device poisoned its host.
Jeanne Lenzer's new book details the unregulated medical device industry. (Submitted by Jeanne Lenzer)

Dr. David Urbach, surgeon-in-chief at Toronto's Women's College Hospital, said that Canada is also in need of better tracking of medical devices.

In a study published last year, he and his colleagues poured over 10 years of medical device records filed with Health Canada. 

"We weren't able to find the rate of recalls mostly because we weren't able to determine how many devices are out there," he said, echoing the situation in the U.S.

Seizure-control device stopped patient's heart

The patient at the heart of Lenzer's book is a man named Dennis Fegan, a former firefighter from Texas.

Fegan had hard-to-treat epilepsy and a Vagus Nerve Stimulator (VNS) implanted in 2000 to help control his seizures. 

But by 2006, he was repeatedly collapsing and losing consciousness. In July of that year, he ended up in an ER after his parents found him passed out in his home.

According to Lenzer, doctors discovered that the VNS wasn't stopping Fegan's seizures: it was stopping his heart.

"His heart was stopping so long, he was passing out and having seizures from a lack of oxygen to the brain." Lenzer said. 

Doctors deactivated his VNS, but Fegan was never able to sue the manufacturer, Cyberonics, because a U.S Supreme Court ruling prevents patients from taking device-makers to court over FDA-approved devices.

The VNS had only been conditionally approved by the FDA because of "a high rate of deaths among the test subjects" — a fact that wasn't required to be told to patients, said Lenzer.

Can you imagine if patients were told, 'Gee, we've got this new device. It might maybe help you. But it also might kill you ... Would you like to try it?' This is sheer insanity.- Jeanne Lenzer

It was later approved for treating depression, even though studies showed it wasn't effective for the condition.

It was one of several devices approved against the advice of FDA scientists in what's come to be known as Device-gate,Lenzer said. 

"The FDA scientists unanimously rejected a number of devices, saying these are unsafe, they shouldn't go on the market and they didn't want to approve them. When suddenly a phone call was made by ... a congressman to FDA managers, and FDA managers overruled their own scientists," she said.

The medical device industry is currently estimated at close to $200-billion a year in Canadian funds. Lenzer said profits, and the industry's close relationship with the FDA, seem to take priority over patient safety.

While Canada has not seen a scandal the like of Device-gate, Urbach said there is a lot of room for improvement in our system. 
Dr. David Urbach says he removes gastric bands every week at Women's College Hospital in Toronto. (Michael Wong/Women’s College Hospital)

As in the U.S., many devices on the Canadian market have not been tested in humans or have been assumed to be safe because they are modifications of existing devices. 

"I don't think we really know these products for certain are safe and effective. There may be unknown risks to all of these medical devices," he said — even though these risks are likely to be "small." 

Urbach said many doctors aren't aware that Health Canada relies on citizens to file reports about devices and adverse events.

He said the manufacturers have a "huge incentive to innovate, create new products and put them out on the market," and the public assumes that the newest technology must be the best, even if that's not always the case.

Giving patients a voice

So what's a patient to do? 

Lenzer said patients are finding their voice in advocacy groups set up to hold companies to account.

Both Lenzer and Urbach advise patients to ask questions about any device, to check existing databases for additional information and to question the need for the device in the first place.

Urbach suggests asking questions like, "Is this absolutely necessary? Are there other alternatives? What's the consequence of not having this particular device used?" are questions Urbach suggests. 

Lenzer said part of the solution has to come from lawmakers. 

"We really need to make the kind of policy and political and health-care changes that will make a difference for patients," she said, adding that she herself has an intra-ocular lens implant following removal of a cataract. 

"Part of my frustration that led me to write this book is that it's disappointing to see devices that are useful tarred by the fact that there are many devices that are causing harm. I want to separate them out so we can all be more secure that ... we know more about our devices before they're put in our bodies."