A new Netflix documentary – The Bleeding Edge – highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always, the patient stories are truly heartbreaking, but what makes this documentary different is the sheer volume of clinical and legal testimony aimed so directly and forcefully at the FDA – the one organization purpose-built to protect patients from a wide range of clinical risks – including those from medical device manufacturers.
According to the documentary (Netflix subscription required), the medical device industry is about $300 billion per year and nearly 70 million Americans have been implanted with a device over the last 10 years. While patient horror stories are always tragic – and there are many horrific ones in The Bleeding Edge – they rarely include practicing doctors as victims. One of the lead stories is of Dr. Stephen Tower – an orthopedic surgeon – who suffered severe metallic poisoning from a hip replacement that used a metal-on-metal device. The primary metal alloy for these joint replacements is cobalt, and according to the documentary, there are now more than 10 million people worldwide who have hips, knees or shoulders made with cobalt parts.
Another compelling storyline was that of Gaby Avina. At different times in her profile, she was a nurse who assisted in the placement of Bayer’s Essure sterilization device, a product spokesperson for Bayer's device, and then finally a victim herself. Marketed as a device with a 99% (or higher) efficacy rate, it turns out that aside from the many adverse events, “women with the Essure device experienced sterilization failure rates that were seven times higher than women who had their tubes tied.”
Video of the FDA Pre-Market Approval hearing (obtained by an Essure patient advocacy group) is particularly damning. Filmed in 2002 during the actual hearing process, members of the panel are seen laughing about the personal consequences if the device ever failed in the future. After thousands of adverse cases, and under enormous patient pressure, Bayer has finally agreed to stop selling the Essure device this year.
As a way to highlight some of the more compelling testimony, here’s my selection of top quotes from the 98-minute documentary.
FDA is the most important consumer protection agency in the world. It regulates virtually everything that comes in contact with the body. FDA is organized by centers – so there’s a center for foods, there’s a center for drugs, there’s a center for biologics, and there’s a center for medical devices. And FDA does a credible job with the vast majority of products. The problem we have is that when it comes to medical devices we built a system that doesn’t work. David Kessler – FDA Commissioner (1990-1997)
This is big business. It’s kind of a parallel to the drug industry and it isn’t nearly as well understood. People think Pharma’s got power. No, no, no – the device industry has much more power than pharma. Jim Spencer – Journalist, Minneapolis Star Tribune
Sure, we’ll pay attention to Washington, that’s my job, that’s what I do – but we have more power in this room than most governments around the world. Scott Whitaker – President & CEO of Advanced Medical Technology Association (medical device lobbying organization)
There is a system for reporting complications, but there’s tremendous underreporting because it’s a voluntary system. David Kessler – FDA Commissioner (1990 – 1997).
If a physician observes an adverse event, they do not have to report it. The only bodies that are required to report adverse events are the companies. It’s estimated that only 3-4% of adverse events are reported to the FDA. Rita Redberg – Editor, JAMA Internal Medicine
The story of how the robot came into healthcare is the story of what’s wrong with medicine in America today. Massive adoption of a new technology with little evaluation of the outcomes.Martin Makary – Professor of Surgery and Health Policy at John Hopkins School of Medicine
Most people probably believe when they get a medical device – be it a pacemaker or a joint – that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them – but for most moderate and high-risk devices that is not the case. For the 510(K) pathway all the manufacturer needs to demonstrate is that their device is ‘substantially equivalent’ – is the regulatory term – to another (predicate) device that’s already on the market. Michael Carome – Director, Public Citizen Health Research Group
You end up with what we call a daisy-chain (of approvals). And then quite often what you found is some of the predicate devices – as they call them – have actually been recalled from the market because they’ve been failing. Deborah Cohen – Associate Editor, British Medical Journal
That [510(K)] provision which was meant as an exception – in essence a little loophole – that exception became the rule. So, the vast majority of devices today – regrettably – are regulated under this [510(K)] framework. David Kessler – FDA Commissioner (1990 – 1997)
At this point, a graphic was shown to indicate that 98% of FDA medical device approvals were through the 501(K) "loophole" and only 2% were through the more rigorous Pre-Market Approval process.
So even if the device was recalled because it was dangerous, you (the manufacturer) can still use it as a predicate and get your device cleared because it’s ‘substantially equivalent.’ So, there are a lot of problems with that 510(K) system and that’s how metal-on-metal hips got on the market. Rita Redberg – Editor, JAMA Internal Medicine
I’m horrified because the more I’m looking at it, I’m beginning to wonder is cobalt the new mercury poisoning. Are these people (with metal joints) being relegated to the dust bin because they have what somebody misperceives as dementia. How many people have been mis-diagnosed with a permanent disease process (like dementia) that actually have a reversible disease process. That’s the horror right there. Robert Bridges – Diagnostic Radiologist
It used to be that about 70% of biomedical research was funded by the government, [but] in the last 20-25 years, that’s changed. Now, about 70% of biomedical research is funded by industry.Adriane Fugh-Berman – Professor of Pharmacology & Physiology, Georgetown University
We can no longer rely on the medical device companies to do what’s in the best interest of the patient, and we can no longer rely on the FDA to properly regulate these devices. Dr. William Kuo – Stanford Health Care