Watch this documentary before you let a surgeon use a robot to cut inside you

Robots are the shiny new toys of surgery in American hospitals. They promise ultra-precise, tiny cuts that give patients faster healing and better outcomes. Wherever you live, your local TV news outlets have likely run uncritical, gee-whiz stories about hospitals and surgeons bringing in these robots, featuring glowing patient testimonials.

So what’s not to like? You need to watch a new documentary airing Friday night on Netflix to get the other side of the story, and there’s plenty. And also about other medical devices that promise much but deliver more pain than benefit.

Careful medical journals have built a growing body of research finding not only a dearth of evidence to support the booming business of robotic-assisted surgeries but also worries about under-reported harms from the procedures. News stories in big media outlets and blog posts have reported on risks and damages associated with the higher-cost machine-assisted operations.

But will “The Bleeding Edge,” a Hollywood documentary debuting this weekend (Friday night) on Netflix, finally break through the collective consciousness with ringing alarms about not just robotic surgery but also the rapacious profiteering of the $400 billion medical device industry?

The work, by two well-respected film makers, delivers a “terrifying” and personalized account of the damage that faulty devices wreaked on a representative group of patients. The stories go beyond robotic-assisted surgery and include an orthopedist driven to the brink, he says, by metal poisoning from a faulty hip replacement, and women whose lives were upended by problematic birth control implants or their gynecologic treatment with eroding surgical mesh.

“Bleeding Edge” makes the case that regulators at the federal Food and Drug Administration, under arcane agency rules, have gone overboard, waving at new products that seem like existing and already approved devices. This lets makers speed little changed, poorly tested devices into markets worldwide, where they are robustly marketed and promoted as shiny, pricey innovations. They rack up billions of dollars in profits for politically powerful device makers who may have paid little attention to damages their costly products can inflict on patients and their pocketbooks.

With robotic surgical devices, fawning local news stories may hype their burgeoning use in unhelpful fashion. But research has failed to show a clear and overpowering benefit to patients for complex machinery that costs hospitals millions of dollars to install — sums they seek to recover with surgeries that cost individual patients thousand of dollars more. The machines may provide surgeons greater comfort as they operate. But there are questions whether they get the training they need to optimize the robot’s capacities, and whether, over time, young surgeons are losing critical skills and experience they need due to the high costs of operating robots.

Those issues, of course, may sound remote compared with the unacceptable reality of patient nightmares that have occurred with surgical robots. Like what? Like vaginal cuff dehiscence — cases in which women, after undergoing robotic hysterectomies, experience their bowels falling out through their vaginas.

In my practice, I see not only the harms that patients suffer while seeking medical services but also their struggles to access and afford safe, effective, and even excellent medical care, especially when they’re injured by defective and dangerous products, notably medical devices. We need lawmakers, policy experts, and especially FDA regulators — starting with industry friendly Commissioner Scott Gottlieb — to step up to protect patients and to stop cozying up with Big Pharma and medical device makers too eager to make a buck at everyone else’s expense.

Jeanne Lenzer, a seasoned medical investigative reporter, has pointed out in her recent book that 32 million Americans — about one in 10 of us — have at least one medical device implanted in our bodies. These include artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. She and the documentarians for “The Bleeding Edge” both have rightly warned that testing and protections against device flaws and defects are far too lax and tilt far too much in favor of makers over patients.

Critics may fault the new documentary for its “overemphasis on individual cases.” But, as experience has shown, such close story-telling may be the most effective way to shock regulators and lawmakers out of their slumbers and into providing needed oversight of a sector that’s shown its prowess in lobbying, marketing, and political donations. It took several deaths, including of infants, and “an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes,” before Bayer just yanked its problematic Essure birth control from sale, the New York Times has reported.

Bayer has denied any problems with the device, though the FDA had just started to curtail Essure sales, notably to ensure women fully understood the implant’s risks. The agency acted only after it received as many as 30,000 adverse event reports, as Madris Tomes, a former agency medical device official who runs a company that analyzes adverse event data, told the New York Times. She was quoted, thusly:

With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer [for Essure] simply didn’t jibe with the data that was pouring into the FDA from both patients and physicians.

Really, that’s the level of damage that it requires for the FDA, taxpayers’ watchdog, to bark and to bite? Unacceptable — and after watching “The Bleeding Edge,” you may feel angrier, still.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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