Living Trials

A local woman fights to spread the word about a device that one doctor says represents much of what is wrong with healthcare



It sounded perfect to Tamara Myers. She was done having children, she was sure of that, and clinical trials had shown Essure to be remarkably effective — 99.8 percent, in fact. The doctor also said it was easy — just a 10-minute procedure that should have her back on her feet in a couple of days.

This was important to Myers, the then-36-year-old who'd grown up in Freshwater and attended Eureka High School. She worked long hours restoring old cars at Harper Motors and had a 14-year-old daughter to look after. Plus, she was helping her father through cancer treatments. She simply didn't have the time to spend weeks recovering from surgery.

With Essure, a doctor at the clinic in Eureka told her, there would be no incisions or cuts, no hospital and no general anesthesia. She could have the procedure done right there in the Planned Parenthood office and she would be heading home within an hour.

So on Aug. 10, 2012 Myers went into the Planned Parenthood building on Timber Falls Court to have the Essure procedure performed. Her life would never be the same.

"The pain was excruciating," Myers said recently, her short blond hair bursting out from underneath her beanie in wisps. Her face offered a smile of the laugh-or-cry variety as she explained that the initial pain was just the beginning and has been followed by daily struggles, two major surgeries and more than 20 frantic visits to the emergency room. "It was like an assault. My whole life and my health were stolen from me for someone's profit. That really pisses me off."

Myers is one of hundreds of thousands of women who have undergone the Essure permanent birth control procedure since it was approved by the United States Food and Drug Administration in 2002. Developed by Conceptus Inc., which was later taken over by Bayer, Essure was designed to offer patients a nonsurgical, non-hormonal alternative to tubal ligation sterilization.

The device itself is made up of two 2-inch-long metal coils — one nickel titanium alloy, the other stainless steel — wrapped around polyester fibers. Using a scope device that enters the uterus through the vagina, a doctor implants one coil in each of the openings of a woman's fallopian tubes. There, the coils are designed to induce inflammation — an immune response as the body attempts to reject them. Over the course of three months following implantation, scar tissue — or a "natural barrier," as Bayer puts it — builds up around the coils, blocking the fallopian tubes and thus the ability of sperm to fertilize a woman's eggs.

Clinical trials found the procedure, when done correctly, to be more effective than tubal ligations — having your tubes tied, in layman's terms — in which a surgeon clamps a woman's fallopian tubes, or severs and seals them. The device went through three phases of clinical trials from November 1998 through June of 2001 and was tested on a total of 745 women.

The FDA classifies medical devices in three categories. Essure fell into Class III, which is reserved for those devices that "support or sustain human life" or are of "substantial importance in preventing impairment of human health," according to the FDA. They require clinical trials — scientific reviews designed to test their safety and effectiveness — and premarket approvals, meaning they are reviewed and signed off on by the FDA before being available to consumers.

The catch with premarket approvals, however, is that it leaves the device's makers immune from liability for personal injuries or adverse affects, meaning the companies making these things can't be sued. That wasn't always the case.

Federal law offers no provision allowing for civil lawsuits against producers of medical devices, so injured patients have historically turned to more stringent state laws, with many winning substantial awards. But in 2004, the administration of President George W. Bush reversed long-standing federal policy and began arguing that the FDA's premarket approval should supersede lawsuits brought under state law. The push stemmed from Bush's belief that frivolous lawsuits were driving up the price of medical services and hamstringing the development of new technologies.

In 2008, the issue made it to the U.S. Supreme Court, which backed the Bush administration with an 8-1 decision. Writing for the majority, Justice Antonin Scalia reasoned that allowing state lawsuits stemming from federally approved devices "disrupts the federal scheme," under which the FDA looks at both risks and benefits. In state cases, Scalia continued, a jury would only see the injured plaintiff and a device's potential dangers, while the patients who benefited from the device would not be represented in court.

Sitting in an Old Town coffee shop on a recent afternoon, Myers said she feels the court's ruling protects corporations while leaving patients vulnerable.

Myers' frustration stems not only from her personal experience, but from knowing she is one of at least 15,000 women who say they have suffered horribly adverse reactions to Essure and have no recourse. Like Myers, many of these women say their lives have been nightmarish since the procedure — a daily maze of pain and confusion.

Julio Novoa is a practicing gynecologist and cosmetic surgeon in El Paso, Texas. He's treated some 15,000 patients and delivered thousands of babies. About a year ago, someone contacted Novoa and asked him to review the information on a Facebook page called "Essure Problems," on which thousands of women, including Myers, were complaining of adverse reactions to the device.

"At first, I was skeptical," Novoa said recently. But that's changed: "In a nutshell, all the weaknesses related to the FDA and all the weaknesses related to medicine as a whole are touched on here. They've all been exacerbated by this particular device as an example of how weak the system really is."

Those weaknesses, Novoa said, start with the clinical trials. Poring through the data, Novoa said he saw that doctors in the trials reported having problems properly placing the Essure devices 14 percent of the time. "These are highly skilled, expert-level OB/GYN docs," he said. "What type of complication rate are you going to see with novices?"

And the way the device was pushed by company representatives almost ensured it was going to be implanted by novices, Novoa said. First and foremost, he said there was a financial incentive, noting that the industry standard had doctors billing $1,500 for a 10-minute, in-office procedure to implant Essure devices. Compare that with the $350 to $500 they'd charge for a hysterectomy — a two-hour long surgery in a hospital setting — and Novoa said it's easy to see why some doctors favor Essure.

But, he said, many doing the implanting are far from experts with a hysteroscope, noting that all that is required for a doctor to implant Essure is a six-hour training from a Bayer sales representative.

For Myers, the Essure implantation was painful, leaving her faint and dizzy. But that was just the beginning. Other symptoms came almost immediately: swollen lymph nodes; a burning sensation in her veins, pelvis and abdomen; numbness in her face and arm; muscle twitches; fatigue; a jolting sensation that felt like electrical shocks; and a metallic taste in her mouth. "The symptoms were basically feeling like I was being poisoned to death," Myers said, adding that she lost 10 pounds in the two weeks after implantation. "I had an immediate reaction."

Myers followed up with her doctor, who said her Essure implants were fine. Whatever was going on with her, he said, wasn't due to the implants. She was referred to three different doctors and visited the emergency room numerous times, but found no answers. The only answers Myers did find were on the Essure Problems Facebook page, which she described as a light in the darkness. "I cannot put into words how it felt," she said. "No matter how many people didn't understand or didn't believe me, now I wasn't alone."

Myers said she found information and a community on the page. She met people like Angela Dese, a Marysville mother of three who underwent the Essure procedure in 2008 and, about six months later, felt her health decline rapidly. She began losing clumps of her hair, gained 75 pounds, got migraines for the first time in her life and suffered constant fatigue, anxiety and depression. "I felt like I was dying," Dese said.

And like Myers, Dese said that when she finally figured out it was Essure causing her health problems, the idea gained little traction in the medical community. A string of doctors told her that whatever was going on with her had nothing to do with the birth control implants.

This is a huge problem that's not isolated to Essure, Novoa said. Even through the clinical trials, he said it was known there were some issues with Essure. For example, he said, the clinical trials showed that in 4 percent of cases, the inserts were expelled from or punctured the fallopian tubes. Yet, Novoa said, Essure offered doctors no protocol for dealing with such complications so they were left with a trial and error approach to treating women. Many, Novoa said, simply told patients they couldn't help and they needed to find another doctor.

Many doctors are operating with a dearth of information, Novoa said. Essure didn't even provide doctors with a full materials list initially, leading to some doctors implanting the devices in patients with known metal allergies. According to Novoa, this underscores other flaws with the FDA's system. First of all, he said most patients don't know to file complaints with the FDA if they're having adverse reactions to a medical device. Then, he said, you have doctors who are reticent to report problems due to liability concerns, fearing that if they acknowledge an adverse reaction it may lead to the determination that they made a mistake. What the FDA needs, Novoa said, is an anonymous problem reporting line for doctors and a clear and widely known way for patients to file complaints. But neither exists.

"So you have women going from doctor to doctor to doctor, sometimes suffering daily pain ... just looking for someone to help them," he said, adding that doctors are overly reliant on the medical manufacturing companies for information about their devices. Novoa said the companies aren't always quick to acknowledge problems in the multi-billion-dollar industry.

In the case of Dese and Myers, this meant the most accurate and reliable information they were getting was being disseminated by women in similar situations on Facebook.

Three pain-filled months after getting her Essure procedure, Myers said she connected with a surgeon at University of California at Davis, who agreed that whatever was going on likely stemmed from the implants in her fallopian tubes. In November, Myers had both her fallopian tubes removed in a double salpingectomy, the type of surgery she'd sought to avoid with Essure.

About 345,000 women

in the United States undergo a permanent birth control procedure every year and there is no perfect method. All have complications and side effects. As the Essure Problems Facebook page's membership eclipsed 10,000, fueled by media reports of complications across the nation, Bayer issued a statement.

"Patient safety is our top priority, and we have great sympathy for anyone who is experiencing pain, regardless of the cause," the company said. "We have also read stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002."

Further, the company said that most of the "side effects" being reported about Essure "are known and included in the Essure instructions for use information." The company's website currently includes chronic pelvic pain, implant migrations through the fallopian tubes, ectopic pregnancies and allergic reactions in its warning of long-term risks.

The FDA also released a statement in the face of the public backlash, similarly saying that many of the adverse reactions to Essure being reported are problems that were found during clinical trials and included in the device's labeling warnings. The FDA maintains that it has found no causal connection between Essure and other reported problems, including extreme fatigue, depression and weight gain.

In defending Essure, Bayer notes that it has sold more than 750,000 devices worldwide, which makes the number of reported problems seem small. But, asked how many of those have been sold in the United States, and how many of those have actually been implanted to date, Bayer spokeswoman Tara DiFlumeri said the company doesn't break down its numbers by country. Without that information, it's hard to put other information — namely the 15,000 women telling horror stories on Facebook and the roughly 1,500 adverse events reported to the FDA — into context.

Both the FDA and Bayer fall back on the clinical trials, saying they have five years of data supporting the claim that Essure is safe. But one aspect of that trial has already been called into question by a Yale School of Medicine study, which calculated that 96 out of every 1,000 women implanted with Essure would get pregnant within 10 years, a deviation from the 99.8-percent efficacy rate trumpeted by Bayer — a stat that rates Essure about three times less effective than tubal ligation procedures. To explain the large discrepancy between studies, the Yale researchers said their study used a larger sample size and accounted for real world variation.

Spokespeople for Planned Parenthood Northern California were not immediately available to comment for this story. Bayer's website lists three local doctors as providing Essure implants. One no longer works in Humboldt County. Another was out of the office on vacation and could not be reached. Attempts to interview the third were unsuccessful.

The last year has been a whirlwind for Myers. Despite having had her fallopian tubes removed, her symptoms have persisted. So, finally, in June of last year she went in for a full hysterectomy. After the surgery, a pathology report revealed she was suffering from endosalpingiosis, with fallopian tube tissue growing on the outside of her uterus.

"I cannot describe the level of outrage I felt," she said. But, Myers explained, that outrage has fueled her desire to make a difference and spread the word. "Knowing what I know, I feel morally obligated to do something about it."

So she's been working on the Essure Problems California Facebook page daily, helping women answer their questions and connect with people who might be able to help them. And she and Dese have taken the fight offline, meeting with the staffs of senators Barbara Boxer and Dianne Feinstein, as well as local Congressman Jared Huffman and state representatives Sen. Mike McGuire and Assemblyman Jim Wood. She's also helping spread the word about a pair of petitions, one seeking to get Essure off the market and the other to repeal the Biomaterial Access Assurance Act of 1998.

Novoa also spends a couple of hours a day on the Facebook page answering questions and giving women advice. But Novoa said he also knows the game is rigged, and real change will only come with reform of the multi-billion-dollar machine that is the health care industry. Specifically, Novoa said the FDA needs to conduct independent audits of clinical trials instead of operating on the honor system (currently, the FDA simply allows device manufacturers to self-report trial results). Then, he said, there needs to be some sort of system that allows doctors on the front lines to share information and discuss and report problems without exposing them to massive lawsuits. And, he said, patients need more information and informed consent needs to be more than a signature on a form — it needs to be a lengthy discussion of potential risks and rewards, problem protocols and how to report adverse reactions. Patients, he said, need to come first.

For Dese, who has been feeling healthier since a hysterectomy in 2012, Essure was life changing. Like Myers, she said much of her world now circles around the Facebook page. "It went from really being a support group to a movement," she said, adding that she can't imagine her work ever being complete. If Essure is pulled from the shelves, there's FDA reform to focus on.

Back in Eureka, Myers is feeling healthier, for the most part, but still struggles. Earlier this year she went to the emergency room twice in a single week with intense pain and numbness, symptoms of the fibromyalgia she believes stems from her Essure implants. She smiled as she remembered how busy she used to be — following up shifts at Harper Motors by helping her dad reroof their home and taking the dog for walks. She said she misses that energetic person, but she's gone. Myers doesn't think she'll come back.

But Myers conceded that for all the loss that's stemmed from her decision to undergo the Essure procedure, she's gained some things, too. She laughed, remembering a moment of teenage angst in which she said she just wanted a movement to be a part of, something to protest and throw her life into changing. Be careful what you wish for, she said.

"Essure is the best and worst thing that's ever happened to me," she said, adding that the procedure has brought the best out of her in certain ways, leading her to find immense satisfaction in helping other people. "I wouldn't trade who I am today for who I was before Essure, but I also shouldn't have had to go through that."

She paused a moment, looking down at her coffee, reflecting.

"What can you do other than fight?"

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