This is the kind of cogent, well-researched exposé that, if activists weren’t tearing their hair out over Syria, North Korea, Bob Mueller’s investigation, Scott Pruitt’s cone of silence, global climate change, rampant gun violence, and lettuce poisoning, there might enough of an uproar to generate real reform.
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Two weeks ago, under a concoction that my anesthesiologist dubbed “a Michael Jackson cocktail,” I had a medical device removed from my body.
A surgeon in South Bend, Indiana, pulled a threaded metal stick that held my foot in the proper position after bunion surgery. The bone is healed, and the metal was working its way (shudder) out the top of my foot, so like a pin on a grenade, I had it pulled.
I’m still hobbling, but after seeing The Bleeding Edge, I’m glad my foot didn’t explode.
I am one of 70 million Americans who have been implanted with metal, plastic, polymers, pacemakers, corneas, and more in the past decade. Most of us are wheeled to the OR with a high level of trust for the protocol that brought these devices into our operating rooms.
In the first few minutes of The Bleeding Edge, two-time Academy Award-nominated filmmakers Kirby Dick and Amy Ziering (The Hunting Ground, The Invisible War) offer a quick disclaimer, mentioning all the good things medical devices can do.
It’s the last nice thing they have to say.
The medical device industry is rigged to maximize profit, minimize safety, and – when things go wrong – to marginalize victims and silence the voices that might prevent further harm.
With a title like The Bleeding Edge, I expected disturbing images (there weren’t as many as I was bracing for, because the stories alone are horrific). I wasn’t surprised by the smug attitude of industry executives caught on tape, or the complacency of people in power.
The problem with The Bleeding Edge isn’t the gripping, well-paced, seamlessly produced, scary-as-hell content.
My concern is, in this crowded world of worthy causes, will the documentary produce enough buzz to generate reform.
This is the kind of cogent, well-researched exposé that, if activists weren’t tearing their hair out over Syria, North Korea, Bob Mueller’s investigation, Scott Pruitt’s cone of silence, global climate change, rampant gun violence and lettuce poisoning, there might enough of an uproar to generate real reform.
Especially now, how much outrage can a 99-minute Netflix documentary expect to generate? If enough people watch it, if enough tough questions go unanswered, there might be an election-year push for progress.
The Bleeding Edge highlights case histories of four types of victims: women who suffered permanent damage from Essure – a device marketed as a “simple, nonsurgical, permanent birth control,” an orthopedic surgeon from Alaska who suffered a mental meltdown after his metal-on-metal hip implants began leaching cobalt into his nervous system, a pelvic mesh patient who has lost track of how many surgeries she’s had to remove floating fragments (18? 19?), and several women who display remarkable dignity, considering their insides fell out, days after having DaVinci robots perform remote hysterectomies.
Filmmakers Dick and Ziering let each victim tell their own story, not sparing the ripple effects on spouses, children, and careers. The presentation isn’t sappy or exploitive. It’s real life. We feel their pain.
None of these devices – from the eroding hip replacement to the pelvic mesh that stiffened internal organs – underwent rigorous testing, or required human trials, before they went into our bodies.
Like 96% of all medical devices on the market today, they were “grandfathered in” as part of the Medical Device Regulation Act of 1976.
As long as a manufacturer can point to a device that they claim is “substantially equivalent” to one that’s been legally marketed, it qualifies for PMA (Premarket Approval) under a provision called 510 (K). Even if, the documentary claims, the originally approved device was dangerous or ineffective.
If, somehow, it can be traced back to 42-year-old technology, as far as the Food and Drug Administration is concerned, it’s good to go (inside you).
There’s also a sick symbiosis between doctors and manufacturers’ sales reps, who offer legal kickbacks to surgeons.
I was upset to hear in passing that, while patients are under anesthesia, a salesperson from Johnson & Johnson, Stryker, or Medtronic is probably in the operating room looking over a surgeon’s shoulder offering installation suggestions, or maybe discussing a deep-sea fishing junket off the Gulf Coast.
Former FDA commissioner David Kessler (1990-1997) looks straight into the camera and admits, “We built a system that doesn’t work.”
Why has the US Food and Drug Administration gone along with this dangerous protocol for so long? Because the $400 billion medical device industry is one of the most powerful – and one of the more quiet – influencers in Washington, D.C.
The Bleeding Edge claims the industry’s lobbying arm, Advamed, bleeds green into campaign coffers, to the tune of $64 million in 2017 alone.
Current Commissioner of Food and Drugs Scott Gottlieb, MD, is a prime example of the industry/regulator revolving door. A former attorney for big device-maker Bayer, Gottlieb was accused of conflict of interest during his confirmation hearings. He was confirmed after offering to recuse himself from rulings that involved his former employer (and investment partner) for the first two years of his tenure.
As that sinks in, the audience is treated to photos of other former industry executives, alongside their positions with the FDA, and a frightening segment about whistleblowing research scientists who lost their jobs after suggesting that CT scanners, which can emit the equivalent of hundreds of X-rays in a single scan, might be better off with warning labels.
It may be no coincidence that three of the four nightmare scenarios Kirby Dick selected for his “doc doc” could only happen to women. I can’t help but wonder how the DaVinci robot executives would have reacted if, instead of a hysterectomy patient emerging from the bathroom with two feet of her colon in her hand, men began to report that their penises were falling off after surgery.
Though the documentary’s indictment of government and industry is damning, Dick and Ziering don’t mention one person who bears direct responsibility for the medical device nightmare. His name is Steve Austin.
The FDA isn’t the only one who is complacent when it comes to medical devices. Americans were conditioned, from an early age, to trust them implicitly, thanks to the character played by Lee Majors in the 1973-78 TV series The Six Million Dollar Man. (If ABC-TV revived the show, it would be The $48 Million Man.)
If anyone deserves a kickback from medical device manufacturers, it’s Austin, the fictional astronaut who lost his right arm, both legs, and his left eye in an experimental airplane accident. That incredibly popular TV show, and its spinoff, The Bionic Woman, convinced my entire generation that if something inside our bodies goes on the fritz – a hip joint, a bum knee, foggy vision – there’s a good chance that American ingenuity, dedicated government scientists, and selfless physicians could slice us open, replace the missing or defective part, and make us BETTER than we were before our mishap or disease.
The trouble with the FDA is that it’s working with regulations that were enacted back when The Six Million Dollar Man was still in production.