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The dangerous reality of medical devices exposed in new film

When is tech in the health sector extremely life threatening? In ‘The Bleeding Edge,’ documentary muckrakers reveal it's too many times.

The Da Vinci Surgical System in "The Bleeding Edge."
The Da Vinci Surgical System in "The Bleeding Edge."

The pharmaceutical industry has recently come under intense scrutiny for driving the opioid epidemic, insurance companies and hospitals are faulted for rising health care costs, and even the insurance “middlemen” (pharmacy benefit managers) recently got called out by President Donald Trump for their role in high drug prices. But a new documentary premiering Friday on Netflix asks audiences to pay attention to a health sector they otherwise wouldn’t: the medical device industry.   

The Bleeding Edge is a story in the vein of the big risks with Big Tech — except the risk isn’t being trolled by Russian bots, it’s having your colon literally fall out of your body days after a robot named da Vinci performs your hysterectomy.  

Academy Award-nominated documentary filmmakers Kirby Dick and Amy Ziering reveal, compellingly and thoroughly, how easy it is for medical devices — be they artificial joints or pacemakers — to enter the market without rigorous testing, thanks to government loopholes and powerful lobbying groups. And patients are ultimately the ones who stand to lose.

“We all have to be really aware of not only the products we’re consuming pharmaceutically, but also the products we’re implanting and going to be solicited to implant in the very near future with great frequency,” Ziering told ThinkProgress. She added that this goes for younger patients — invisibles, as they’re called — too. 

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By the end of the film, audiences learn not to assume that manufacturers test medical devices on humans, compile data, and then present it to the Food and Drug Administration (FDA). In fact, these days, most devices get the FDA okay through a loophole used by manufacturers, who point to similar devices already on the market — even though those devices also may not have been tested on humans and, in some cases, may even have been recalled.

A 510(k) exception, as it’s called, is how doctors are able to implant vaginal mesh into patients who need pelvic floor treatments, without any prior testing on humans, according to the documentary. Some doctors were told the mesh was superior to the traditional stitches, but many patients treated with mesh would dispute this, including Tammy Jackson, who’s featured in the film. The mesh was scarred into Jackson’s pelvic tissue around delicate organs, including the urethra. Thus began her cascade of medical troubles, as it is impossible to fully remove vaginal mesh once it takes hold in the body. When it was partially removed, she thought she could go on with her life, but she discovered her mistake while having intercourse with her husband. The mesh had cut him.

Ana Fuentes, in a scene from “The Bleeding Edge,” whose life was ruined by Essure.
Ana Fuentes, in a scene from “The Bleeding Edge,” whose life was ruined by Essure.

Jackson is one of several patients featured throughout the film — most of them women — who cite initial discomfort with their medical device. Early in their stories, it’s almost easy to dismiss the pain they feel (one woman even convinced herself that her pain was in her head) — and given everything we know about how women’s pain is minimized in the doctor’s office, many likely were not believed at first. But what starts as pain inevitably turns into serious medical problems that debilitate every aspect of their lives. Perhaps most heart-wrenching is Ana Fuentes’ experience with the birth control Essure, a four centimeter coil that caused her so many health problems, she ultimately lost her job. In one of the documentary’s final scenes, Fuentes, a single mother, is forced to leave her four daughters with a church foster family, as she can no longer afford to support them. It appears that medical debt drove her to it.

A week before The Bleeding Edge official release, the manufacturer of Essure, Bayer AG, announced that it would take the birth control implant off the market after this year, citing declining sales.

“In my opinion, it is for business reasons,” Dick told ThinkProgress. “The real reason is not declining sales. The real reason is that they knew that the truth will finally come out and really make them look bad and they tried to somewhat dodge the bullet … I think people will be enraged at Bayer and rightfully so.” 

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The filmmakers said the patient advocates who fought to get Essure off the market were “absolutely elated” by last week’s news.

“I hope that everybody sees this as not the end of the story, but the beginning,” said Ziering. “Now, let’s look at all the ones that are still on the market. What do we do about those and what needs to change in order to make this whole health care system and the device system a much safer one for everyone.”

Indeed, the fight has just begun, as the medical device industry still has a tight grip on FDA leadership and Congress, both Republicans and Democrats alike. The industry has an ally in FDA commissioner Scott Gottlieb, who has worked with a range of medical device companies before being appointed as commissioner. The Medical Device Manufacturers Association has spent millions lobbying Congress and building allies as it tries to repeal an Obamacare tax on medical devices. This week, the House successfully passed legislation to that effect.

“What we show within medical devices is that these companies are putting profits over patient safety,” said Dick. “You’re coming into that system where that’s the motivator. So, yes, you have to step up — and you and your advocates have to step up and protect yourself.”

For this, patients and doctors need to stay vigilant. This is film is for them. For us.