Unchecked Power

‘The Bleeding Edge’: Not Even Doctors Know How Medical Devices Are Regulated

A new documentary alleges that America is letting the medical device industry get away with murder—in some cases, quite literally.

Courtesy of Tribeca Film Festival

Angie Firmalino, a mail carrier in upstate New York, was like thousands of women trying to take control of her birth control. Instead of popping a daily pill, she wanted a simpler system, an implant that would help prevent an unplanned pregnancy.

So Firmalino turned to Essure, a birth-control implant meant to prevent pregnancy with 99 percent efficacy.

What was supposed to be a straightforward procedure turned into a nightmare for Firmalino, which she described in vivid detail in The Bleeding Edge, a new documentary that premiered at the TriBeCa Film Festival in New York City and is set to be released on Netflix this summer.

In the documentary, Firmalino described the intense pain and bleeding that resulted from the procedure as looking like “a horror scene.” She goes on to form a group for people who’ve experienced negative health problems after Essure implantation, and tens of thousands of women join to tell their stories and demand action from Bayer (the company who manufactures and sells Essure), Congress, and the FDA.

To the filmmakers, Essure is emblematic of the immense unchecked power of the $400 billion-a-year medical device industry. Seventy million Americans have a medical device implanted within their body. "When it comes to medical devices, we built a system that doesn't work," David Kessler, the former FDA commissioner, said in The Bleeding Edge.

The disturbing truth is that, despite so many people relying on such implants, the medical device industry is very weakly regulated. Companies can manufacture and sell devices based on previous iterations that may already have been recalled. Sometimes, these products haven’t even been tested for the purpose they’re sold. And more often than not, they haven’t even been tested in the patient population they’re supposed to serve. If they have, the effects might not have been studied for more than a few months before they are marketed to the general public.

And many doctors have virtually no clue how badly regulated these products are when companies are hawking them. Companies have learned how to exploit a host of loopholes, especially in 510(k) and Premarket Approval routes for FDA approval, for getting medical devices on the market at just a fraction of the stringent rules required.  

Sometimes, these products haven’t even been tested for the purpose they’re sold. And more often than not, they haven’t even been tested in the patient population they’re supposed to serve.

This isn’t just a problem local to a few devices; rather, it’s a systemic problem. “It’s everyone who is exposed to devices, from birth to death,” producer Amy Ziering told The Daily Beast. “If you’ve ever had an x-ray, or you wear contact lenses to see, this is for you. Devices are us, and our world will continue to use more of these. There’s an issue here that actually puts our lives in peril.”

While there are countless examples of shoddy medical devices harming patients in some way, a 99-minute documentary can only focus on a few big examples. One compelling example is that of Dr. Stephen Tower, a surgeon from Alaska. Tower received what he thought was a standard hip replacement. But immediately afterwards, he began to suffer a mental breakdown when the cobalt metal in his new hip implant degraded, giving him cobalt poisoning. Tower worked backwards to figure out the problem—all while his mental health was in shambles. Tower is only able to salvage his mental health when he receives a new, non-metallic hip replacement, virtually eradicating his symptoms.But Tower realizes there are countless others who are being misdiagnosed for Parkinson’s, Alzheimer's, and dementia—all because of the cobalt in their new hips.

Another story the film tells is of a vaginal mesh which received approval for use in 2002 in gynecological surgeries despite virtually no testing that demonstrates it’s fit for such a use. The mesh went on to create more problems than it solves in several women—even cutting a woman’s husband’s penis when the couple attempt to have sex. Johnson & Johnson suffered $300 million in lawsuits in the ensuing decade as a result.

When you consider that the company made $683 billion in the same time frame, as Ziering emphasized, there’s little financial incentive for these companies to properly test their devices for safety.

I think one of the biggest lessons of this film is that doctors are victims too.
Kirby Dick, director

The medical device industry has become a daisy chain of faulty and harmful products. And companies know they can get away with it.“Part of the problem is that people don’t know about this because they think it’s too complicated, so they just trust their doctors,” said Kirby Dick, the director of the film. “That’s a mistake, since doctors don’t even know how these things are sometimes regulated.”

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Indeed, one particularly powerful scene pits Essure protesters against physicians visiting a medical conference. Many of the doctors balk at what the women who’ve suffered Essure-related complications allege. Dick saw some of the skepticism expressed by doctors before they’d seen the film, though he’s been encouraged that most of them leave the theater realizing how much they have yet to learn. “I think one of the biggest lessons of this film is that doctors are victims too,” he said. Case in point: Dr. Tower, the surgeon with the hip replacement.

At its core, The Bleeding Edge wants viewers to be suspicious of buzzwords like “new” or “innovative.” The name of the documentary itself comes from a phrase describing emerging technologies that are so risky for early adopters to use, and could create a slew of problems in the long run. “In so many cases, something that’s new is untested, and it’s much riskier than things that have been around for decades,” Dick said.