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The motel where Ana Fuentes arrives one evening with her young daughters charges $110 for a single night and doesn’t offer weekly discounts. Fuentes asks the cashier for a moment so she can think about it.

Outside, the camera captures an anguished look on her face. It’s clear she can’t afford the expense. She books the room anyway. “Do you like it?” she asks her girls as they excitedly unpack their bags.

The family used to have an apartment, but Fuentes had to visit the emergency room so often that she lost her job, her daughters explain on camera.

Such situations aren’t rare in the United States, where experts have repeatedly warned that millions of Americans have almost nothing in savings and are a single medical disaster away from financial ruin. The problem is compounded nationwide by costly healthcare, lack of access to paid sick leave in the workforce, or a combination of the two.

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But Fuentes’ story, like dozens of others featured in an upcoming expose about the medical device industry, has a particularly cruel twist. She says in the film that she was healthy until a doctor convinced her to undergo what was supposed to be a routine, non-surgical medical procedure -- getting small birth control implants permanently embedded into her fallopian tubes.

The $155 billion medical device industry has mostly avoided the type of scrutiny that drug companies and health insurers sometimes face from elected officials and others. On Friday, a documentary about the device industry and patients like Fuentes called The Bleeding Edge is set to go live on Netflix, bringing what advocates hope will be widespread attention to an industry increasingly characterized by lax safety standards, enormous power in the operating room, and horrific side effects.

“If you're going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” says Dr. Diana Zuckerman, a health policy analyst who has worked in the White House and as a staffer in Congress.

The current president of the National Center for Health Research, Zuckerman and the other researchers at her non-profit are among the few to have taken interest in faulty medical devices.  

Diving into the medical device industry

Hollywood directors Kirby Dick and Amy Ziering knew they wanted to make a documentary film about preventable medical injuries, Dick tells ConsumerAffairs, but that was about it.

Sitting in on one patient advocacy meeting for research, they caught a presentation that Zuckerman gave about the medical device industry and the ease with which questionable products get on the market. They decided that they had found their story.

The team interviewed approximately 70 patients to make their film, Dick tells ConsumerAffairs. The film also includes interviews with numerous whistleblowers, such as doctors, former Food and Drug Administration (FDA) researchers, and one medical device sales rep who requested anonymity in exchange for speaking on camera.

Dick and Ziering were previously nominated for an Oscar for The Hunting Ground, their documentary about sexual assault on college campuses. Another earlier film, The Invisible War, is an expose about sexual assault in the military.

But persuading people to speak out against the device industry made for the most challenging interviews they’ve done, Dick tells ConsumerAffairs. (A medical device industry lobbyist touts in one scene that the industry is more powerful than some national governments.)

The “E-sisters”

As the film and the research it is based on shows, the problem is bigger than any single device. The Bleeding Edge captures the story by focusing  on four implants -- three of which were used exclusively women’s reproductive organs.

The narrative is driven forward by the story of the “E-sisters,” or the activists who say that they suffered debilitating side effects after receiving the permanent birth control implant Essure.

For years, the “E-sisters” have organized a grassroots campaign to convince regulators to ban Essure from doctors’ offices. That goal seemed like an uphill battle until last week, when Bayer suddenly released an announcement that Essure will no longer be sold in the United States by the end of the year.

Bayer frames the move as a “business decision.” The announcement came one week before the Netflix documentary was scheduled for release.

"I’m very glad that these issues are getting this kind of attention, and I hope that Bayer’s decision to take Essure off the market won't take away from the bigger message of the film,” says Zuckerman, “which is the whole process for devices that makes no sense at all.”

“Why in the world would you want to have a regulatory agency in our government, the FDA, having much lower standards for devices than they do for prescription drugs?”

Essure implants

The story of Essure, in particular, only saw the light-of-day thanks to the “E-sisters,” who count 30,000 people in their Essure Problems Facebook group and have convinced numerous elected officials, doctors, and even early clinical trial participants to join their cause.  

"One of the things that is disturbing to me is that these issues only came to light because of the work of victims," former Representative Mike  Fitzpatrick (R-Pa.) said in an interview several years ago.

Women who agreed to participate in clinical trials for Essure in the late 90s have said that they there were sold on a pitch to get a free, non-hormonal, and permanent birth control that was already proven safe.

A nickel coil, the size of a ballpoint pen, would be placed in each fallopian tube. That was designed to create an inflammatory response so that the coils would become permanently encased in the resulting scar tissue.

Regulators with the FDA approved the device in 2002, despite admitting that they knew little about the long-term side effects of such a procedure, as footage that the E-sisters had obtained captures. What’s more, numerous clinical trial participants later said that their painful side effects were not included in the company’s official data.

Doctors not long after began using the devices without questioning potential risks. “For some reason we did that to women. And I did that, too,” Dr. Shawn Tassone, an Austin-based gynecologist, tells ConsumerAffairs.

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Photo courtesy of Netflix

Insurance and profit margins

The sales representatives who taught doctors how to place the devices -- something that Bayer has defended as a common industry practice -- offered no instructions on how the device should be removed if there were side effects.

“We were just told from the very beginning that even if they're misplaced, you don't have to remove them,” Tassone remembers.

The role that insurance coverage may have played isn’t examined specifically in The Bleeding Edge, but testimony from patients and doctors suggests that getting insurers to cover Essure proved much easier than getting them to cover removal.

Tassone remembers that both private plans and Medicaid paid fairly generously for the Essure procedure, especially considering that inserting Essure was much cheaper and less labor-intensive than tubal surgery, the older sterilization procedure.

"If you think about a tubal ligation where you go to the operating room, it's $400 [in profit] give or take,” he say. “Essure in the office, after you subtract the amount of the device, it's probably $1100."

Treating any resulting side effects proved impossible for women navigating unfamiliar territory. Angie Firmalino, the New York City mail carrier who founded the E-sisters network, initially seeked help from a doctor who morcellated the coils into small pieces -- sending the nickel elsewhere in her body.

Connecting patients with doctors who are willing and able to properly remove the devices, as well who are able to code it correctly so that insurance will pay, has since become one of the E-sister’s major tasks.

Tassone, for his part, implanted his last Essure device in 2013. He says it was a call from another doctor who convinced him not to perform the procedure anymore; a woman with Essure apparently had gotten pregnant, he was told, which can be extremely dangerous for both the baby and the mother. One researcher has counted 303 fetal deaths linked to the device.

Tassone has since switched sides, counseling the E-sisters online and in the operating room. He estimates that he has conducted 600 Essure removal surgeries.

Trust remains despite ban

In recent years, the advocates have convinced the FDA to add a black box warning to Essure. Later on, they were able to help pass a rule which requires doctors to give patients more detailed warnings about the product.  

But that didn’t appear to stop most doctors from trusting the device. The American College of Obstetricians and Gynecologists continues to say on its website that lasting pain from the procedure is “rare.” By contrast, nearly 27,000 reports have been filed to the FDA’s “adverse event” report database describing health problems caused by Essure and 16,000 lawsuits have been filed here. An estimated 750,000 women worldwide have undergone the procedure.

Now that Essure is off the market, doctors may be more willing to attempt removal surgery, Tassone says, something he thinks is necessary but frightening

“They're going to think its not a big deal to take out,” he worries. (More detailed advice about removal surgeries is offered on the Essure Problems page).

Generally, before any major surgery involving a permanent implant, researchers advise patients to press doctors on the specific devices that will be used. Zuckerman, the health policy analyst who helped inspire the Netflix film, recalls that even she struggled to get specific answers when she asked a doctor what brand of hip he would choose for her own surgery.

The procedure ultimately went well, she says, but trying to search for good data comparing brands beforehand was nearly impossible.

“In the vast majority of cases, the surgeons are still quoting the company data,” Zuckerman says. “The company's data on humans is nonexistent --  at least publicly.”


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