One night in April 2015, Keisha Carney tried to go to bed in spite of a bad toothache, which turned into an even worse headache — the kind that doesn’t let you sleep. “I couldn’t stand still. I was up walking around,” she says. She woke her husband, who called her dentist’s emergency line and then drove to a 24-hour pharmacy for pain medication.

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The next morning, Keisha had an emergency appointment with the dentist, who looked in her mouth and shook her head. “She was like, ‘What happened?'” Keisha recalls. Her wisdom tooth was so infected it needed to be extracted. It was the first of five teeth she’d lose.

Carney, 35 at the time, had never had bad teeth; in fact, she was known for her huge pearly smile. Despite juggling work and a large family, including 8-month-old twins, the Dumfries, Va., resident was in good shape all around. “For some perspective, my wife is a unicorn,” says her husband, RW Carney, 37. “She’s one of those women who wore heels her entire pregnancy, no issues, no nothing.”

But suddenly lots of “little things” were going haywire with Keisha’s body, the couple recounts for me as we sit in their neat, airy suburban townhouse about 30 miles south of Washington. Her hair was falling out in clumps, she was having unusually heavy periods and severe cramps at odd times in her cycle, she was gaining weight and battling brain fog and severe fatigue — even when she’d slept.

Then, another problem cropped up: Keisha missed a period. This was strange, because seven weeks after her twins were born, Keisha’s obstetrician-gynecologist had inserted a “permanent contraceptive” device called Essure, made by Bayer. Keisha and RW had eight children between them at that point. “God has blessed us abundantly,” says Keisha. “We knew we were done.”

Keisha had originally asked to have her “tubes tied,” the common term for surgical sterilization. But she says her OB/GYN suggested Essure, a permanent contraceptive that had been developed in part to avoid the risk associated with the incisions and anesthesia used in tubal ligation. The brochure Keisha was given touted Essure as “the most effective method of permanent birth control available” — 99.74 percent. It described the device as two “soft, flexible inserts” that, in a “gentle, non-surgical” procedure, are passed through the vagina and cervix into the fallopian tubes. There, the inserts, which do not contain or release hormones, help generate scar tissue that blocks the tubes. “It sounded more natural,” says RW.

Though Keisha thought she had forever taken care of birth control, the feeling that she might be pregnant kept nagging at her. (She had used an alternative form of birth control for three months after she received Essure, as her doctor had told her to do. But because of a lapse in insurance coverage, she had not returned at that time for the medical procedure necessary to confirm her tubes had been completely blocked by the device.) So, she picked up a drugstore test to set her mind at ease. When it was positive, “I was devastated,” she says. “My husband had to literally pick me up off the floor.”

News

  • In July 2018, Bayer announced it would stop US sales of Essure at the end of the year, effectively pulling the device from all markets.

    FDA inaction on Essure spurs letter from members of Congress.

    Essure recalled from store shelves across the globe, including Australia, the European Union and Brazil.

  • In a March 2018 press release, the FDA noted that the agency is actively evaluating nearly 12,000 new medical device reports received in 2017 for Essure.

    In February 2018, after FDA Commissioner Gottlieb met with affected women, Essure remained on the market. Two months later, the FDA restricted the sale and distribution of Essure.

After the shock wore off, Keisha went online and found a Facebook group called Essure Problems. She began reading post after post from its roughly 16,000 members (today the number is almost twice that). There were women who wrote about the kind of bleeding, fatigue, hair loss and tooth decay that Keisha was experiencing, which they attributed to allergic or autoimmune reactions to materials, especially nickel, in the device. There were women who reported that their devices had migrated out of their fallopian tubes and embedded in the uterus or punctured other organs. There were women who had decided to have the coils removed via surgery and reported winding up with complications from the operations, and often hysterectomies. There was even a subgroup of women who posted pictures of their “E-babies.”

Reading through the posts, Keisha began to think that all the strange “little things” happening in her body might be explained by a reaction to the device she had chosen for birth control. To begin with, she is so sensitive to nickel that she can’t wear her white gold wedding ring for more than a couple of days because it contains the metal. (She says her doctor didn’t ask if she was allergic to nickel; the doctor declined to discuss Keisha’s case for publication, citing privacy laws.)

Now she was devastated, scared and angry. Why had her doctor recommended this? And why hadn’t she done more homework before agreeing to it? “I blame myself for this part, that I never really thought about something foreign being in my body forbe the rest of my life,” she says.

Keisha Carney, here with son Malik, endured adverse effects that she attributes to Essure, before and during a pregnancy. Essure's manufacturer, Bayer, says the device has been used successfully by hundreds of thousands of women. Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

Nobody can say exactly how many women have had Essure implanted since the device went on the market in 2002. Bayer, which is headquartered in Germany, says that more than 750,000 devices have been sold worldwide and that sales “continue to grow.” (According to data from Essure clinical trials, device insertion fails anywhere from 4 to 12 percent of the time, making actual usage unclear.) In a telephone interview, Patricia Carney, director of U.S. medical affairs for Bayer Women’s Healthcare, pointed to the total sales number as evidence that “hundreds of thousands of women who’ve received Essure … successfully achieved permanent contraception without having to go through an invasive surgical procedure.”

Interview

In recent years, the Food and Drug Administration has received more than 16,000 adverse-event reports about Essure. These are official reports about symptoms, hospitalizations or diagnoses that patients, doctors, hospitals or a device manufacturer believe are associated with a device. They can prompt the agency to order a change in labeling, the addition of warnings or, in rare cases, the removal of a device from the market. Among the reports are nearly 9,000 surgical removals of Essure, mostly by hysterectomy. “That’s a lot of surgeries for a device that’s considered minimally invasive,” says Madris Tomes, a former FDA analyst. Although she and other experts in FDA law and regulation emphasize that there is no magic number of reports that will trigger an investigation, complaints can serve as an important signal to the FDA that it should take another look at a drug or device. (The FDA declined an interview for this article but responded to questions in writing.)

Carney helps son Mekhi, on the trampoline, with Malik's twin, Khalil, center, and Malik.Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

Activism can make a difference as well. In 2012, a group representing the women who had coalesced on the Essure Problems Facebook page began contacting the FDA, asking for meetings. In 2015, the FDA held a hearing on the device, which, Tomes says, was probably a direct result of the women’s persistence. “There has to be a pretty big outcry for there to be a public meeting,” she says. In 2016, that hearing resulted in a “boxed warning” about possible side effects, including persistent pain and allergic reactions. Black box warnings, as they’re commonly called, are among the strongest action the FDA takes to warn the public about potential dangers of a drug or device, and they are exceedingly rare for devices, according to Suzan Onel, a lawyer with Kleinfeld, Kaplan & Becker who has 27 years of experience in FDA device law. The FDA added the warning, it said at the time, because it believed “that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically-placed tubal implants that are intended for sterilization.”

Impact

  • Following Block’s investigation, Consumer Reports cited her reporting in a post warning women of the sometimes serious medical complications that arise from Essure.

  • Her investigation was also cited in a JAMA journal editorial, discussing the long-term safety of hysteroscopic sterilization.

The warning — coming 14 years after Essure went on the market and two years after Keisha had it implanted — was a major victory for anti-Essure activists. But it also left a number of unresolved questions: How did this device come to market? What made it so popular? And should women continue to use it? To find out, I interviewed 14 women who have or used to have Essure, doctors who both implant and remove it, medical device engineers and consultants, researchers, women’s health advocates, and FDA and industry representatives, including for Bayer. I also reviewed the company’s data, transcripts of FDA hearings, court documents, heavily redacted FDA filings obtained by Freedom of Information Act request, medical research, hundreds of Facebook posts and data from adverse-event reports.

“It seems every two or three years we have another controversy in women’s health,” says Steve Xu, a health-­policy researcher and Northwestern University dermatology resident who co-wrote a paper that found “significant weaknesses” in FDA approval of high-risk gynecological devices. “We have pelvic mesh, we have concerns with morcellators” — devices used during hysterectomies that can spread undiagnosed cancer. “And then with Essure, it’s like, here we go again.”

 

 

At a radiology conference in 1987, a doctor from Portland, Ore., named Amy Thurmond presented data on a technique she had pioneered to treat infertility: unblocking fallopian tubes using a tiny catheter guided by an imaging technique called fluoroscopy. After the presentation, Julian Nikolchev, a medical entrepreneur, approached her with a question: Couldn’t the technology be turned on its head for the opposite purpose? “He had the idea that there could be placement of a device or chemical in the fallopian tubes nonsurgically to prevent conception,” recalls Thurmond.

In 1988, Thurmond and Nikolchev began testing the idea in rabbits, whose fallopian tubes have a similar structure to those found in humans. Nikolchev worked with Silicon Valley engineers, patents show, and raised $35 million of venture capital, according to news reports at the time. In the early 1990s, he founded a company called Conceptus to develop and market what it would call a “non-incisional permanent contraception” device. (Nikolchev did not respond to interview requests.)

The prototype of Essure had a ribbonlike steel outer coil soldered to a tightly wound steel inner coil that was wrapped in polyethylene terephthalate (PET) fibers. The goal wasn’t for the device itself to block the tubes, but rather for it to stimulate what’s called foreign body response: The fibers would irritate or inflame the tissue, which would signal the immune system to surround the foreign body with cells that form scar tissue. This would encase the device and occlude the tubes, as researchers described in a 2001 study published in the journal Fertility and Sterility.

Initial testing on 37 rabbits found that the device was highly effective in preventing conception when it was correctly placed and didn’t move. But that happened only about 60 percent of the time, Thurmond and Nikolchev reported in a 2004 paper in the Journal of Women’s Imaging.

For its first FDA-authorized human trial, which began in 1998, Conceptus kept the basic design but altered the metal coils to prevent them from moving, the 2004 paper explains. For its outer, ribbonlike coil, it chose a relatively new material in the medical device arena called Nitinol, which had been developed at the now-closed Naval Ordnance Laboratory in Silver Spring, Md. (coincidentally, the current location of the FDA). Nitinol, a flexible nickel-titanium “shape memory” alloy, as it is known, can be set to take a shape at a certain temperature, relax at a lower temperature and bounce back once warmed up again. For Essure, shape memory meant that the coils could be packed tightly in a slim delivery catheter. Once they hit body temperature, they would expand, allowing the PET fibers in the device to incite the “acute inflammation followed by chronic inflammation” that would generate the scar tissue and block the tubes, according to the 2004 paper.

While Nitinol had been used in medical devices since the 1980s, there were already published reports of failures with cardiovascular stents made of the material and of patients developing reactions to metal implants in general. According to Peter Schalock, a Boston-area dermatologist who has published extensively on metal hypersensitivity, reactions to implanted devices can include rashes or eczema, chronic inflammation and chronic pain, all of which are among the adverse events reported by Essure women.

Schalock and several experts in immunology or toxicology expressed concern at the 2015 FDA hearing that the nickel in Essure could be triggering allergic or autoimmune reactions, in which the immune system overreacts and attacks healthy cells. In addition to the issue of nickel, he and other physicians have raised concerns about the PET fibers used to incite the inflammatory response: “Maybe the inflammatory state goes a little wild,” Schalock told me. “The question is what’s driving it. Is it the Essure, or is the Essure waking up some sort of predisposition to autoimmune disease?”

I raised these questions with Bayer, which purchased Conceptus in 2013 for $1.1 billion. The company acknowledged in an email from its communications office that “a small amount of nickel is released from Essure” and said it would continue to analyze complaints about nickel sensitivity. Patricia Carney of Bayer says that tests for leaching in Phase I trials concluded that “the amount of nickel that comes out of the Essure inserts is actually far less than what comes out of most of the nickel-containing devices that are on the market.” In response to the possibility that the device could be causing autoimmune reactions, Carney points out that autoimmune disease is already common in women. “What we then have to tease out is why are women having these symptoms,” she says. “Because they’re happening in women both with Essure and without Essure.”

Melissa Davis-Gilbert talks with her husband, Dan, before a hysterectomy to remove her Essure coils. Davis-Gilbert, a nurse from Havre de Grace, Md., had originally opted for Essure about a decade ago to avoid surgery. She says that after experiencing pain, fatigue, rashes, joint swelling, difficulty concentrating and respiratory issues, she decided to have the device removed.Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

Before selling Essure to the public, Conceptus had to submit the device to scientific and regulatory review by the FDA’s Center for Devices and Radiological Health. The Center, which was established in 1976 in the wake of the crisis over the Dalkon Shield — an intrauterine device that caused several deaths and generated thousands of lawsuits because of its design, materials and lack of testing — has different requirements for approval of medical devices than the Center for Drug Evaluation and Research, which reviews drugs. “The legal standard for approving a drug explicitly requires adequate and well-controlled clinical investigations,” says Patricia Zettler, former associate chief counsel for the FDA, who now teaches food and drug law at Georgia State University. In contrast, for devices, the standard is “reasonable assurance” of safety and effectiveness, she says, which is subject to interpretation.

Conceptus applied for approval of Essure in the category of Class III medical devices, which, according to the FDA, “are generally the highest risk devices and are therefore subject to the highest level of regulatory control.” This class goes through the most rigorous application process for devices, known as premarket approval. But it is also the only class of device shielded from most lawsuits, thanks to a 2008 Supreme Court decision that makes it difficult for patients to sue in state court for devices that have received premarket approval. In addition, the FDA granted Essure expedited review, a legacy of AIDS activism intended to speed access to potentially lifesaving therapies, in which the FDA puts a treatment at the beginning of a review queue and provides advice on clinical trial design. The FDA fast-tracked Essure, it said, “because this device offers significant advantages over existing approved alternatives.”

Although Class III devices are protected from most lawsuits and undergo the most rigorous approval process, they are not required to undergo randomized controlled trials — in which one randomly assigned group of patients gets the treatment, another group gets a different treatment, and the outcomes are compared. The FDA said in a written statement to me that it did not believe a control group was necessary for Essure because, at the time, “effectiveness and safety outcomes for laparoscopic tubal ligation were well known from years of clinical use” and could be used for comparison. Sanket Dhruva, a Yale University cardiologist and researcher of high-risk medical devices, strongly disagrees. “We all know the most rigorous data in clinical medicine is through randomization,” control groups and follow-through, he says. Ideally, he explains, the researchers would have given 1,000 women Essure and another 1,000 women laparoscopic sterilization and followed them for five years to compare rates of pregnancy, complications, hysterectomy and repeat surgeries. Without a real-time comparison, he says, “we just didn’t have the data.”

For its third, “pivotal” trial, the most important for achieving approval, Conceptus reported on 439 women. None of the women became pregnant, for an effectiveness rate of 100 percent — though Conceptus noted that “no method of contraception is 100% effective, and pregnancies are expected to occur in the commercial setting.” The company compared this to a long-term study of 10,000 women who elected tubal ligations, which found a rate of pregnancy of 5.5 per 1,000 for the first year. A “serious adverse event” — in which the Essure device perforated the fallopian tube, was expelled or wasn’t placed correctly — occurred in 4.6 percent of participants. After one year of use, according to the data, 9 percent of women reported back pain, 3.8 percent reported abdominal pain and cramps, and 3.6 percent reported painful sexual intercourse.

When asked if this was an acceptable number of adverse events, the FDA said in its response to me that Conceptus demonstrated “reasonable assurance that the device is safe and effective for its intended use.” It went on to explain: “In determining safety and effectiveness, the FDA weighs any probable benefit to health from the use of the device against any potential risk of injury or illness from such use.” One important benefit, according to the FDA, as well as many doctors and researchers, was that women seeking permanent sterilization could avoid surgery by opting for Essure. (It has been estimated that there are about four deaths per 100,000 surgical sterilizations, and a complication rate — involving bleeding, infection, organ damage or anesthesia reaction — of 1.6 percent.)

The fact that Conceptus had only followed the women for one year — the company itself noted that “the risks of long-term implantation [of Essure] are unknown” — also troubled Dhruva. A short-term study “might be okay if it’s a medication that you take for a week,” he says. “But we’re talking about a device that’s going to be implanted in a million people for the rest of their lives.”

In order to monitor any potential long-term effects of the device, one of the FDA’s conditions in approving Essure under expedited review was that the company would continue to follow the women from the pivotal study for at least five years. That data, which was submitted in 2008 but not posted by the FDA until 2014, reported that 92 percent of the 384 participants said overall comfort was “excellent” and 97 percent said they were “very satisfied.” But the company noted that 30 percent of the original study group could not be followed for the full five years. This was yet another weakness of the studies, says Dhruva, because if those women had a complication or got pregnant, the outcomes wouldn’t be reflected in the results.

Looking back on Essure’s clinical trials, Dhruva and two other Yale-based physician researchers took the FDA to task in a 2015 opinion piece in the New England Journal of Medicine, citing the “large numbers” of adverse events reported since the device went on the market, such as incomplete procedures, tubal perforations, pain and bleeding leading to hysterectomies, possible device-related deaths and likely a higher number of unintended pregnancies than previously disclosed. “We believe that these safety concerns, along with problems with the device’s effectiveness, might have been detected sooner or avoided altogether if there had been higher-quality premarketing and postmarketing evaluations and more timely and transparent dissemination of study results,” wrote Dhruva, Joseph S. Ross and Aileen M. Gariepy. When asked, the FDA declined to respond to the article. A Bayer representative said, “We disagree with many of the assertions in this article and remain confident that the benefits of Essure outweigh its risks.”

Dhruva, who has been researching high-risk devices for nearly a decade, says the Essure case is just one example of “substandard data” used for device approval. “And unfortunately,” he says, “I think a lot of women have suffered from consequences.”

OB/GYN Paul MacKoul performs a hysterectomy on Melissa Davis- Gilbert to remove Essure coils, shown adhering to a fallopian tube. Scrub nurse Karen Ricupero, first assistant Tito Fernandez and MacKoul during the surgery. These photos, and the one above, were taken, and are being published, with the consent of the patient and medical staff.Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

After its approval, Essure was welcomed with open arms by the women’s health community, which had been seeking an alternative to surgical tubal ligation — at that time the most common form of contraception for women over the age of 40. In 2002, “the availability of an easier, faster, safer sterilization technique” was a big advance, says Cindy Pearson, executive director of the National Women’s Health Network. This enthusiasm extended to physicians as well, and many became early adopters of Essure. “I saw it as a game-changer with respect to female sterilization,” says James Robinson, a gynecologic surgeon at MedStar Washington Hospital Center. He estimates that he implanted hundreds of the devices in the decade he served as an OB/GYN with George Washington University Medical Center and says he never had patients return with complaints.

Other factors might also have influenced doctors’ enthusiasm for Essure. For one thing, it takes less time to implant the device than to perform tubal ligation surgery in a hospital. Then there are the reimbursement rates. In 2011 documents created by Conceptus for its sales team, the company estimated that a doctor who inserted 60 Essure devices a year would net $66,747.78, or slightly more than $1,100 per device. By contrast, a physician is reimbursed about $510 by private insurance for surgical sterilization in a hospital, according to Amino, a company that uses U.S. insurance claims data to help consumers estimate health-care costs.

Barbara Levy, vice president of health policy at the American Congress of Obstetricians and Gynecologists and a former consultant to Conceptus, says the higher reimbursement rate is meant to cover office overhead and the equipment necessary to insert Essure, not to serve as an incentive for doctors to recommend Essure over tubal ligation. But Robinson argues that the rate does present an incentive, “and it’s supposed to.” He believes that the idea behind the Essure reimbursement rate is to steer doctors away from the more costly hospital-based procedure.

The problem with a procedure that reimburses well, Robinson contends, “is that everybody jumps onboard: ‘Oh, I’m going to do Essures and I’m going to pay my kids’ college tuition.’ ” But Essure isn’t appropriate for every woman, he says, and should be inserted only by doctors who understand and can manage the risks.

RW Carney watches as four of his children — from left, Malik, Khalil, Mekhi and Brianna — play with Diggy the dog. Mekhi was born after Keisha had the Essure devices implanted.Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

Like many of the women I spoke to, Angie Firmalino, 45, says that her doctor recommended Essure. Shortly after her 2009 procedure, which she says was excruciating, the Tannersville, N.Y., woman began having constant bleeding and pain. She developed joint problems that she attributes to an autoimmune response and had to have surgery to remove the coils. The operation left fragments behind and resulted in a hysterectomy. She’s still dealing with chronic pain, muscle weakness and blood circulation problems, which she also thinks are autoimmune related.

In 2011, Firmalino decided to start a group on Facebook to share her experiences with female friends. Then, strangers started requesting to join and “telling their horror stories, some worse than mine,” she says. Soon the Essure Problems group had hundreds, then thousands of women. They wrote graphic descriptions of their pain and blood loss, fatigue and weight gain; they posted pictures of their thinning hair and bloated bellies that could be mistaken for marking the weeks of pregnancy. And they shared the stranger symptoms: joint pain, sudden muscle weakness, skin rashes. “That’s when the talk started about what is this device made out of?” Firmalino says. “Then we discovered there’s nickel in the device. None of us knew.”

The handful of women administering the group began researching the device and submitting requests for federal records. One of the details that disturbed them was that the Conceptus vice president who presented the application to the Center for Devices’ OB/GYN devices advisory panel, Cindy Domecus, had been an industry representative on that same panel from 1995 to 2001. In 2002, when Domecus appeared before the panel on behalf of Essure, four of the panel’s nine voting members, including the chairman, were people she had served with. (Domecus declined to comment for this article.) When I asked the FDA about Domecus’s tenure on the panel, it noted that industry representatives cannot vote. However, Diana Zuckerman, president of the National Center for Health Research, which scrutinizes industry influence in health care, believes sitting on the panel gives industry members advantages by allowing them to build relationships and gain “a better understanding of how to influence the vote.”

Another concern for the women involved the nickel. The 2002 package label listed nickel allergy as a “contraindication” (meaning the device should not be used for patients with that condition) and included a directive that physicians screen patients for the allergy. The women learned, however, that in 2011 the FDA granted a Conceptus request that the contraindication be downgraded to a “warning,” which doesn’t require physicians to screen patients. (The current labeling includes a nickel warning. The FDA told me it used a warning rather than a contraindication because it “concluded that the data did not meet the threshold of known hazard.”)

Yet another issue the Essure Problems administrators believe got short shrift was removal of the device. A Conceptus representative testified at the 2002 hearing that taking it out would require cornual resection — removing the area where the fallopian tubes meet the uterus. But doctors have since found that’s “not easy,” says Myron Luthringer, a Syracuse, N.Y., OB/GYN who says he has removed hundreds of the devices. He explains that the coils are fragile and break apart, that the tissue in that area is difficult to repair and that PET fibers have often embedded in the surrounding tissue. For those reasons, he says, he tends to perform a hysterectomy, removing the uterus and cervix, as well as the fallopian tubes. Other physicians do as well. “We really advocate that the right procedure is hysterectomy,” says Paul MacKoul, an OB/GYN at the Center for Innovative Gyn Care in Rockville. But hysterectomy — and cornual resection, for that matter — require the very element many women who chose Essure were trying to avoid: surgery with anesthesia. “Anything that’s designed to be permanent is very difficult to take out,” notes MacKoul’s partner and fellow OB/GYN, Natalya Danilyants.

  • More than 5,200 women have petitioned to sue Bayer over Essure in five separate state courts.

In 2012, the Essure Problems administrators began contacting the FDA, asking for meetings; first, they got a conference call, then a sit-down. A few months later, environmental activist Erin Brockovich launched a campaign against Essure, which led to media attention. In 2015, the FDA scheduled the public hearing before the Center for Devices’ OB/GYN devices advisory panel — the same one that had approved the device in 2002 (only one of the 2002 members remained). Such meetings are infrequent, though they are standard protocol when the FDA investigates complaints regarding a medical device.

At the Sept. 24, 2015, hearing on the FDA’s Silver Spring campus, 22 women testified about their symptoms and the impact they said Essure was having on their relationships, their sex lives, their ability to take care of their kids and their ability to work. The women also recounted how their concerns had been dismissed by physicians who told them there was no way the device could be causing their problems. One woman, Gabriella Avina, had participated in the clinical trials and spent years as a paid spokeswoman for Conceptus. “As I became the face of Essure women, my health was in a grave tailspin,” she said.

Amy Reed, an immunologist who was fighting a separate, personal battle against morcellators, told the panel, “Women are presenting just like you would see in a rheumatologist’s office — hair loss, rashes, joint pain, tired.” She called these “classic symptoms” of an immune system gone haywire. Her husband, Hooman Noorchashm, a surgeon also trained in immunology, pointed out that “this device is not designed to cure an incurable disease. … It’s a medical device that’s completely avoidable. And what I want to know from this panel is what percent harm are you going to accept: 0.1 percent, 1 percent, 5 percent, 10 percent? And how are you going to justify that?”

The panel members themselves had some tough comments for the FDA and Bayer, especially on the issue of nickel sensitivity. “How do we not have data on nickel allergy when we have a device that’s 55 percent nickel and 20 percent of women — approximate numbers — are known to be nickel allergic?” asked Schalock, the Boston-area dermatologist and expert in metal hypersensitivity, who served on the panel in 2015.

Fourteen months after the hearing, the FDA announced the black box warning, which alerts patients to reported device migration, perforation, persistent pain and “suspected allergic or hypersensitivity reactions.” The warning and a patient-doctor discussion checklist appear in the 27-page patient information booklet that all women considering Essure are supposed to receive, to be signed by both doctor and patient. (The checklist includes statements such as, “I understand that should my doctor and I decide that Essure should be removed after placement, an additional surgical procedure may be required. In complicated cases, my doctor may recommend a hysterectomy.”) The FDA also ordered Bayer to conduct another clinical trial, this time with a control group: 1,400 women will get Essure, 1,400 will have a surgical tubal ligation, and they’ll be followed for three years. The results are due in 2023.

Throughout the pregnancy, Keisha managed to continue working from home as an IT consultant; twins Khalil and Malik play.Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

The 16,373 adverse events related to Essure that were reported as of May 31 include accounts of devices that broke apart, migrated out of the fallopian tubes or punctured other organs; there are also reports of systemic autoimmune reactions, pregnancies (about 1,100), miscarriages and stillbirths. There are four reports of adult death, though the FDA notes that “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”

These numbers are not easily found on the FDA’s website, or even by doing a search of its public database for adverse events, known as MAUDE. They came from Madris Tomes, the former FDA analyst, who left to launch her own search software, which she says is better at analyzing the agency’s raw data. The FDA does not dispute her numbers (it counts 14,919 medical device reports related to Essure through December 2016). Tomes is helping the Essure women pro bono.

In early May, Tomes and several women from the Essure Problems group met on Capitol Hill to rally support for the 2017 Medical Device Safety Act, which would eliminate the protection from state-court lawsuits that the 2008 Supreme Court ruling gave to Class III medical devices. (Despite the ruling, more than 5,200 women have petitioned to sue Bayer over Essure in five separate state courts, some of which have ruled that the suits can initially go forward, according to Holly Ennis, a personal injury lawyer at Ennis & Ennis who represents hundreds of women who say they were injured by the device. Many of these women are hoping the suits will lead to a recall. Bayer, however, notes that “to date, 23 cases in the Essure litigation have been dismissed in their entirety or significantly narrowed.”) But the Medical Device Safety Act isn’t likely to get traction. Last year, President Barack Obama signed legislation that expedited the approval process for drugs and devices. President Trump has promised to make that process even smoother, and the House recently approved a bill that would ease reporting requirements for medical device manufacturers.

  • “I really feel betrayed. I was only 36 and I'm having to have a hysterectomy?”

Much of the U.S. medical community continues to endorse Essure. The American Congress of Obstetricians and Gynecologists opposes the black box warning, citing a lack of “good, solid data,” as Levy puts it. Planned Parenthood, which spoke in favor of the device remaining an option at the 2015 hearing, still offers Essure at 18 affiliates. And many physicians and researchers, as well as the Center for Devices’ OB/GYN panel and Bayer, say Essure should stay on the market while further studies about its effects are conducted, because of the risks posed by the surgical alternative. Health-care watchdogs counter that there are other options available, such as IUDs, as well as vasectomy, which does not pose the same surgical risks as tubal ligation. For its part, the FDA told me that it “continues to believe Essure is safe and effective for many women — but also that some women experience very serious and sometimes debilitating problems.”

Sales, meanwhile, seem to be falling domestically: According to Athenahealth, a medical billing management company, sales of Essure among the 1,938 U.S. medical providers in its database who implant it have dropped by 70 percent since 2010. A Bayer representative said in an email that the company “will discontinue distribution for commercial reasons in most of the countries in Europe, Latin America and Canada and in the few markets in Asia Pacific where the product is commercialized.” The company attributes this to low sales, “nothing related to safety.”

Robinson, the MedStar doctor, still admires the technology and thinks Essure has been effective for most of the women who have it. But, he says, doctors should have taken the potential risks more seriously: “The last thing you should be doing is saying, ‘This is in your head, don’t worry about it.’ That’s the kind of crap that sends people over the deep end, and for good reason. We need to take responsibility for the things that we do.”

Two of Keisha Carney's sons at home.Image: KATHERINE FREY/WASHINGTON POST MAGAZINE

Twin pregnancies are notoriously difficult, but for Keisha Carney, her final singleton pregnancy was worse. She was constantly in pain — sometimes she’d be doubled over until the stabbing feeling subsided. She also had an ache in her lower back that would sometimes paralyze her for several minutes at a time. Little could be done to ameliorate her pain without potential danger to the baby.

There were more sleepless nights and continued hair loss — which she dealt with by wearing a wig or extensions, something she’d done for years anyway. She had root canals and enamel caps to try to save the teeth she still had. The changes in her mouth affected her connection with the outside world. “I stopped wanting to go out,” she says. “People think of you a certain way when you’re missing teeth.”

Throughout the pregnancy, Keisha managed to continue working from home as an IT consultant, though she was depressed and in pain. All she could do was wait until the scheduled Caesarean section, when, following the birth, her OB/GYN would remove the coils and her fallopian tubes. But after the baby — a small but healthy boy named Mekhi — was delivered, her doctor informed Keisha a “tiny fragment” of coil had been left behind. That meant Keisha, who had toddler twins, a newborn and surgery to recover from, had to undergo a hysterectomy. Her new surgeon found the fragment, as well as a larger piece of coil that had migrated outside of her uterus, near her colon.

Keisha immediately noticed changes after her hysterectomy. She says the stabbing pain stopped, her hair started to grow back and she has had no cause to visit the dentist. Still, her memory isn’t what it used to be, she has ongoing arthritis in her knee and ankle, and the ache in her lower back remains. “I worry it’s kind of like a thing that never ends,” she says.

Things are looking up in other ways. Mekhi quickly caught up in size to his older brothers — today they’re often mistaken for triplets — and the family is making things work. Yet the couple remain angry. “I really feel betrayed,” says Keisha. “I was only 36 and I’m having to have a hysterectomy?” She also thinks the FDA should be held accountable. “Whoever said, ‘Yes, we can put this on the market,’ sometimes I wish they would have to endure what we’ve gone through.”

This article — and an episode of “Reveal,“ a public radio program and podcast from the Center for Investigative Reporting and PRX — was reported in partnership with The Investigative Fund at The Nation Institute, now known as Type Investigations. You can find the “Reveal“ episode at revealnews.org/podcast beginning July 29th.