By Emily Cox
A new Netflix documentary, The Bleeding Edge, highlights massive shortfalls and systematic flaws in the FDA’s medical device regulation, complete with clinically gruesome and heart wrenching patient stories backed by an enormous volume of clinical and legal testimony attacking the one organization the government specifically tasks to protect patients from clinical risks.
The Netflix documentary indicates that the medical device industry is roughly a $300 billion per year business.
“This is big business,” Jim Spencer of the Minneapolis Star Tribune said in the documentary. “It’s kind of 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.”
Nearly 70 million American have received one of these devices in the past 10 years. However, insiders are condemning the FDA’s medical device regulation, or lack thereof, from all sides.
“FDA does a credible job with the vast majority of products,” David Kessler, FDA Commissioner (1990 -1997), said. “The problem we have is that when it comes to medical devices, we built a system that doesn’t work.”
Furthermore, it appears that the medical device industry is running the show, while the FDA continues to play the yes-man, leaving device studies in the hands of those who would profit from them.
“It used to be that about 70 percent of biomedical research was funded by the government, [but] in the last 20-25 years, that’s changed,” Georgetown University pharmacology & physiology professor Adriane Fugh-German said. “Now, about 70 percent of biomedical research is funded by the industry.”
Netflix Documentary Indicates No One is Exempt from Medical Device Dangers – Even Doctors
The Bleeding Edge documents horrific patient stories like many clinical documentaries. However, the Netflix documentary also includes doctors among the medical device victims’ ranks. One of the documentaries primary stories details the experience of orthopedic surgeon Dr. Stephen Tower. He suffered severe metal poisoning from his metal-on-metal hip replacement. The primary metal alloy in these particular joint replacements is cobalt – a known carcinogen and toxin. According to the Netflix documentary, more than 10 million people worldwide have joint implants made with the toxic metal.
Diagnostic radiologist Robert Bridges expressed grave misgivings over the metal being placed into patients’ bodies with these implants
“I’m horrified because the more I’m looking at it, I’m beginning to wonder if cobalt is the new mercury poisoning,” Bridges said. “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?” he continued. “That’s the horror right there.”
Gaby Avina was a nurse who assisted with the placement of Bayer’s Essure sterilization device. Then, she was a product spokesperson for the birth control device. Finally, she was a victim herself.
Bayer marketed the Essure device as having a 99 percent (or higher) efficacy rate. However, the Netflix documentary asserts that, aside from the many adverse events including debilitating pain and death, the device’s failure rate was also seven times higher than tubal ligation.
Video of the Essure Pre-Market Approval hearing is particularly disturbing. Filmed during the actual hearing in 2002, panel members laugh about the personal consequences if the device ever failed in the future. After thousands of devastating adverse cases and worldwide outcry, Bayer finally agreed to stop selling the Essure device earlier this month.
Netflix Documentary Condemnation of the 510(k) Clearance Program
As inadequate as Essure’s FDA Pre-Market Approval appears, there was at least some sort of process involved. The FDA introduced the 510(k) approval process as an exception to provide faster approval for devices that are essentially the same as ones that have already passed the FDA’s more rigorous traditional Pre-Market Approval process. However, the Netflix documentary indicates that this loophole has become exceptionally problematic, allowing manufacturers to flood the U.S. market with potentially dangerous devices.
Several experts throughout the documentary came down hard on the 510(k) program as being irresponsible and hazardous to patient health.
“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,” the director of Public Citizen Health Research Group Michael Carome said. “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’ to another device that’s already on the market.”
“You end up with a daisy-chain [of approvals]. And then, quite often what you find 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 of British Medical Journal, said.
“So, even if the device was recalled, because it was dangerous, you can still use it as a predicate and get your device cleared because it’s ‘substantially equivalent,” JAMA Internal Medicine editor Rita Redberg said. “So, there are a lot of problems with that system and that’s how metal-on-metal hips got on the market.”
“That provision was meant as an exception – in essence a little loophole. That exception became the rule,” Kessler said. “So, the vast majorit of devices today, regrettably, are regulated under this [510(k)] framework.”
The Netflix documentary indicates that 98 percent of FDA medical device approvals are through the 510(k) loophole, leaving only two percent that actually go through the more rigorous Pre-Market Approval process.
Netflix Documentary Shows FDA Is Not Protecting Patients
The Netflix documentary makes it clear that the agency that the government designed to protect patients from an exceptionally large and powerful industry segment is bowing to the influence of that very segment, leaving patients vulnerable and at the whim of a for-profit system that only views patients in terms of sales figures.
“We can no longer rely on the medical device companies to do what’s in the best interest of the patients. And, we can no longer rely on the FDA to properly regulate these devices,” Dr. William Kuo of Stanford Health Care said.