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Their Doctors Wouldn't Listen — So They Took Their Fight To The FDA
4 Apr 2016 4:30 PM
Sniffs and stifled sobs erupted as 37-year-old Sharilyn Ervin spoke into the microphone. “My 12-year-old was my caretaker. She had no life at 12. She changed my diapers,” she told a panel of representatives from the U.S. Food and Drug Administration (FDA) and Bayer Pharmaceuticals back in September 2015. “She took me to the potty. She bathed me. She had no childhood,” Ervin continued. Panel chair Cheryl Iglesia, MD, kept her stoic gaze as she brushed a single tear away from her left cheek.
It would be the only display of emotion from the panel as roughly 20 women shared similar stories of complications, injuries, and suffering related to Essure, a non-hormonal permanent birth control device manufactured by Bayer. Ervin's daughter was forced to care for her after she experienced cramping, bleeding, and a loss of bowel control after Ervin had Essure implanted, resulting in a 17-week hospital stay, she said.
Around Ervin sat hundreds of women like her, from all over the country. The women, who call themselves “E-Sisters,” had been fighting for this day for a little more than five years. Bayer stands behind its device and says patient safety is its top priority. “The safety and efficacy of Essure is supported by more than a decade of science and real world clinical experience,” says Tara DiFlumeri, the company spokeswoman.
In the U.S., around 62% of women of reproductive age are using some form of contraception currently. While two-thirds of those women use non-permanent methods like the pill, a full 25% of them choose sterilisation. Every method of birth control, every medical intervention, comes with risk, but as complaints have grown, evidence has mounted that Essure’s risks may not have been clearly communicated with patients. Some experts say there were flaws with the studies that supported the FDA’s approval of the device in the first place and that the FDA may be grossly underestimating the magnitude of the problem, Refinery29 found in this investigation.
Ahead, you’ll hear all sides of the story, starting with the women who demanded that their doctors, the FDA, and Bayer listen to what they had to say.
The Facebook Group That Started It All
Since Essure, which is a set of small metal coils placed in the fallopian tubes, was approved by the FDA in 2002, thousands of American women have come forward with stories of injuries and malfunctions related to the device. But it wasn't until the media caught on to a Facebook group called Essure Problems in 2013 that concern over the device reached a fever pitch.
In 2011, the same year she had her Essure coils removed, Angie Firmalino logged onto Facebook and created the Essure Problems group. She says on the group’s fundraising web page that after being implanted with Essure, she experienced heavy bleeding, fatigue, back pain and sharp stabbing pains in her lower left side; her physicians discovered years later that one of her Essure coils had migrated into her uterus and the other was “embedded in my uterine wall," she writes. “I started a page on Facebook called Essure Problems, to warn my friends and family about this procedure, and share what I had been through."
Members of Essure Problems interviewed by R29 felt that, in general, their doctors were not responsive to their complaints, and so they went looking for some kind of outlet. They turned to each other for understanding, finding each other online in Firmalino’s group, which has now grown to about 28,000 members over the past five years, with dozens of posts and comments being added every day. They’ve developed their own lingo, calling themselves the “E-Sisters” and congratulating each other when another woman becomes "E-Free."
“I have probably read a quarter of a million posts, day after day, week after week, month after month from women in debilitating pain, women suffering, having no one who will believe them that Essure may be the cause, let alone help them,” Firmalino said at the FDA hearing back in September. “If this were men complaining of pain, bleeding, or sexual dysfunction after having a medical device implanted in their testicles, no doctor would question the cause or hesitate to remove the implant.”
One member of the group, Lisa S., says that she felt immediate regret when she got Essure in 2008. Her lower abdomen twisted in pain as she walked out of her appointment. “I had the feeling that I shouldn’t have done this,” she says. (Lisa's lawyer's requested that we do not use her full name as they are pursuing litigation.)
Lisa says that Essure was recommended by her doctor as a permanent birth control option and would require zero downtime. To a full-time graduate student and a working mother of three, that sounded pretty good: She didn’t have time for a day off. Unfortunately though, from the day she had the device implanted, Lisa says she started having very heavy menstrual periods, and that her symptoms escalated over the next three years to fatigue, cramping, and painful sex.
Years ago, at 22, Lisa had been diagnosed with endometriosis, a disease that causes endometrial tissue to grow outside of the uterus. It is known to cause many of those same symptoms Lisa was experiencing, including heavy periods and pain. But she insists that after surgery in her 20s to treat her endometriosis she didn't have any problems — until she got Essure at 38. Almost all of the doctors she saw thought her symptoms were related to endometriosis, not Essure, but she wasn’t convinced.
Around September 2013, she found the Essure Problems group online and was shocked to see women talking about the same side effects. At that time, there were about 1,700 members. She immediately joined, becoming an admin the following year. She's now the leader of the New York Essure Problems group, one of a handful of regional offshoots that each host intermittent in-person meet-ups.
“I was in shock at first and spent time reading posts of so many women going through the same health concerns as me. The admins were amazing and informative. I immediately took an interest in helping these ladies. The support was like no other,” she says.
An Epic Failure
Essure was designed as an alternative to tubal ligation (a.k.a. “getting your tubes tied”) for women who are done having children or don’t want to have children. Within three months after implantation, scar tissue is supposed to naturally form around the coils until the tubes are completely closed off, so sperm can’t reach any eggs. The draw is that implantation doesn’t require any surgery or recovery time, yet it is meant to permanently prevent pregnancy just the same. On Bayer’s Essure website, they estimate the device has been implanted about 750,000 times worldwide. The company does not share country-level sales data, but DiFlumeri told Refinery29 in an email that the total number of Essure kits sold worldwide is actually closer to 900,000 and that the “majority of these are in the U.S.”
Bayer also asserts that Essure is 99% effective at preventing pregnancy. And there's no hard scientific evidence yet to dispute that. But in addition to complaints of pain, bleeding, fatigue, and others, many of the E-sisters (and experts on their side) say that not only do their stories indicate that in practice, Essure is not as effective at preventing pregnancy as Bayer's studies suggest, but also that when it does fail, it can go horribly wrong.
In early 2010, just three months after Cecilia Bogle had the two metal coils inserted into her fallopian tubes, she found out during a routine follow-up to make sure her tubes were sufficiently blocked (called a hysterosalpingogram, or HSG test) that one of her coils was in an “extrauterine position" — meaning it was either misplaced or it had migrated. Either way, her tube was not blocked, and a few days later she noticed her period was late; 10 days after her HSG test, a pregnancy test came back positive.
Women are counselled to continue using an alternate form of birth control for the first three months after the procedure, and Bogle says she continued to take her birth control pills as recommended. To be fair, Bogle’s story represents a truth many women know first-hand: birth control can and does fail. But Bogle says she never would have expected a failure of this magnitude.
Five months after Bogle happily (though unexpectedly) gave birth to a healthy baby girl in September of 2010, her doctor recommended that she have a hysterectomy because she was having very heavy periods and other symptoms like cramping and stomach pains. During the hysterectomy, doctors attempted to remove the coil that had migrated, but could not find it, she says. Later, during a second surgery to remove her fallopian tubes, doctors found “questionable beginnings of perforation” in the left fallopian tube and were able to remove the coil, but they still could not find the right coil, according to medical records provided to Refinery29. Bogle had multiple procedures over the next few years, including colonoscopies and other GI exams, in an effort to figure out both where the coil was and whether it was causing her symptoms. Her sex life with her husband became strained. And in 2014, she was diagnosed with a nickel allergy. (Essure, like other medical devices including heart stents, contain nickel that can cause reactions in those who are sensitive.)
Finally in 2015, a CT scan found evidence that the fragments of her right Essure coil were located in Bogle's abdomen. To this day, she still has fragments embedded somewhere in her ascending colon and lower abdomen. Bogle continues to suffer from nausea, bloating, severe stomach, back and joint pain, and migraines. “I am in pain every day. Some days are worse than others,” she says.
“As a husband, it is hard to see your wife in pain,” Bogle’s husband David said at the FDA hearing. “Having to watch my wife go through multiple surgeries and the risks involved, it is extremely stressful and downright scary.”
Throughout all of this, Bogle has been an active member of Essure Problems. She says that the group started tallying unintended pregnancies in 2012, jotting them down into a database whenever a woman posts an incident to the Facebook group, and she took over the task from another admin in January 2015. "In our group alone, we have had 650 reported pregnancies to our group; 273 of those have been reported to miscarry. That's approximately 42%," she said during her speech at the September 2015 meeting with the FDA.
The FDA recently updated their website to reflect the number of reports of pregnancies and foetal deaths they’ve received. The website now states that the FDA itself has received 631 reports of pregnancies in patients with Essure: 150 of these pregnancies resulted in a live birth, 204 had an unknown outcome, and 294 ended in pregnancy loss, including 94 ectopic pregnancies, 43 elective terminations, and 155 miscarriages.
In all, this may not sound like a large number given that an estimated 900,000 Essure devices have been sold, by Bayer’s count. Essure’s makers stand by their promise that it is 99% effective at preventing pregnancy, comparable to other birth control methods on the market. But at least one 2014 study, published in the journal Contraception, found that the risk of pregnancy was higher in those with Essure than in women who received other sterilisation procedures, like tubal ligation or a Falope ring procedure (which is a silicone ring implanted around the fallopian tubes).
The authors of that paper also bring up some drawbacks to the procedure: “The likelihood of achieving successful bilateral coil placement on first attempt varies from 76% to 96%.” The researchers also mention the three month delay Bogle was warned about, during which women must use an alternative form of contraception. After this three month period, women are supposed to have the HSG test to make sure the scar tissue has formed and the procedure was successful, as Bogle did.
But the researchers write that “prior research has shown that some (6 to 87%) women never return” for these tests, and for up to 16% of women who do have the test, blockage hasn’t occurred after three months. The “multiple steps” involved may be why the rate of failure is higher for these women, the researchers conclude.
Ultimately, then, the question is: Are women who choose this procedure being appropriately informed about the pros and cons?
Bogle says she was only told by her physician that Essure was 99% effective at preventing pregnancy, and that as long as she stayed on her birth control for three months and came in for the three-month follow-up, everything would be fine.
According to Lisa S., her doctor told her that less than one% of women have side effects like migrations and pregnancy. Lisa S. did not have her follow-up test until five years later, in 2013, because she had too many scheduling problems, she says. “Every time I had an appointment, I would be bleeding and had to cancel,” she says. Lisa stated that she finally got the follow-up test a few months after she joined the Facebook group, and it revealed that her tubes were sufficiently blocked. But by this time, she had been having symptoms like pain, chronic fatigue, and intermittent bleeding for years, and so she decided to have a hysterectomy to have her coils removed. It took a long time, but she is now pain-free and has plenty of energy again, she says.
The Day They’d Been Waiting For
At 5:39 a.m. on September 24, 2015, Krystal Donahue, 39, steered her blue Ford Flex through the mist of the Maryland White Marsh Mall parking lot. This was a day she and other members of the Essure Problems Facebook group had been demanding through statewide meet-ups and media posts for a long time: The first hearing on Essure at the FDA headquarters. Donahue, another of the Facebook group’s administrators, would be one of the women to speak alongside Ervin. She felt a combination of stage fright, anger, and concern that despite the hearing, the agency wouldn’t take any meaningful action to protect women.
Donahue says the Essure coil procedure left her feeling fatigued and nauseous for days afterward, and that her symptoms escalated to extreme pain, heavy bleeding, and a trip to the emergency room. She went back and forth between doctors for two years before finding one who could remove her coils, finally having them taken out on her 37th birthday. “It was a birthday gift to myself,” she says.
By the time of the hearing, the women, who were demanding an outright ban on the device, had received the attention of medical providers and researchers who shared their concerns about its safety. Hundreds of attendees, including physicians and women with Essure, traveled from across the country to see what was to become of the device.
On the way to the FDA hearing, Donahue picked up fellow E-Sister and Syracuse resident Sheila Pitt. It was the first time they had ever met in person, but the two women embraced in the parking lot. “I don’t know if I have any tears left,” Pitt said at the time.
Unlike most of the women at the FDA hearing, Donahue wasn’t hopeful that the FDA would recall Essure. She was too realistic about the political realities that could keep the device on the market. A lot of powerful people are making a lot of money from the device, she said.
Deborah Kotz, an FDA spokeswoman, says that it is not unusual to have a public hearing about a medical device, “but we certainly don’t do it for every device.” A few times a year, the FDA will conduct hearings about the safety of a device if there is a noticeable increase in adverse events. The organisation will then evaluate the post-market approval by consulting with a panel of manufacturers and physicians.
Inside, hundreds of people were gathered in a large conference hall. Two security guards and a long, red nylon rope separated the attendees from the FDA and Bayer panelists. The hearing began at 8 a.m., and for three hours, the FDA and Bayer representatives explained their findings from the pre- and post-approval studies conducted through Conceptus, the company that owned the device until Bayer acquired it in 2013.
At 11:10 a.m., speakers from the public were given the chance to present their speeches. Donahue had practiced her speech for an hour the night before. Her voice shook as she talked about the time when her pain was so sharp and intense, it caused her to spasm on a doctor’s exam table, and how she suffered from abdominal pain, painful sex, extreme fatigue, joint pain, rashes, and abdominal swelling.
“I am not an extreme case,” Donahue told the panel. “My coils did not migrate or perforate. I did, however, endure physical pain and mental anguish for two years after being implanted with Essure.
“Despite the thousands of women harmed and despite all the data presented here today, Bayer and the FDA have difficulty seeing the causal relationship between Essure and our health due to limited data,” she continued.
Donahue took her seat to vigorous applause from those who sided with her. The faces of the Bayer and FDA officials did not register any response.
Many more patients — 22 women total — testified at the hearing. Another 21 speakers included several physicians, CEOs, and women’s health representatives from Planned Parenthood and the American College of Obstetrics and Gynecologists. Most urged Bayer and the FDA to conduct more studies.
After the hearing, DiFlumeri, the Bayer spokeswoman, said, “Bayer stands by the positive-risk profile of Essure, and we look forward to working with the FDA as it considers the Panel’s advice.”
Incomplete Data: What Experts Have To Say
The “E-Sisters” were able to start the conversation, but even with their harrowing stories, it is hard to say just how risky Essure really is. And that’s the actual problem: We don’t know enough about Essure to quantify the hazards — and these unknowns have persisted since the beginning, with some experts arguing the device never should have been approved in the first place.
As patient complaints have increased, experts like Charles Monteith, MD, a North Carolina-based surgeon and Sanket Dhruva, MD, a postdoctoral fellow at Yale University, have gone back and looked at the science behind the approval of the Essure device. Their conclusions are startling: They say that there were flaws with the two studies that supported the FDA’s approval of the device all the way back in 2002.
Dr. Monteith, medical director of A Personal Choice Tubal Reversal Center, says that the pre-approval studies for Essure did not measure the risk for long-term health complications, only the risk for complications early on. In his opinion this boils down to “running an uncontrolled trial on American women as a result of the decisions that were made when the device was approved.”
The studies included data from a total of 745 women followed for five years after getting Essure. None of the women became pregnant, and adverse events “that prevented reliance on Essure for contraception” were observed in 9% of women in one study and 2.6% of the women in the second study. These included instances of perforation, expulsion of the coils from the fallopian tubes, and misplacement. Still, since no pregnancies occurred in the first study and at the five-year follow-up, Essure was deemed a successful preventative permanent birth control and was approved by the FDA.
Dr. Dhruva, whose research focuses on medical decision-making, including FDA approvals, published a paper in the New England Journal of Medicine in October that looked back at the possible flaws in the pre- and post-approval study results of Essure. (Post-approval studies are common and meant to examine the results from pre-approval studies of medical devices once they’re on the market.) He found that the studies didn’t compare results against the current method of sterilization, the tubal ligation, and in fact, most of the women in the original studies weren’t even followed for the full five years. Of the 745 women included in the studies that led to the approval of Essure, only 197 were still being followed after two years.
On top of that, Dr. Dhruva writes that FDA approval was conditional on the publication of post-approval studies, but that those have flaws as well. One is still ongoing almost 14 years after approval, and another, which enrolled 518 women and followed them for five years, neglected to include those women whose placements were unsuccessful, or who underwent hysterectomy within that time, in the effectiveness analysis.
Without accounting for every person in the studies, and without including a control group who received the alternative, tubal ligation, the medical community has a difficult time assessing the true risks and benefits associated with Essure, Dr. Dhruva says.
An ideal study would take a tubal ligation group and an Essure group, follow them for at least five years, and compare the endpoint results (bleeding, unintended pregnancies, hysterectomies, and so on). “Once enrolled, you always follow. That’s an obligation taught in medical school,” Dr. Dhruva says, conceding that “it can be difficult to follow every patient,” but it’s “the goal.”
The bottom line: The limited data on Essure’s effectiveness points to “inflated success rates and deflated failure rates,” adds Aileen Gariepy, MD, a Yale Ob/Gyn who worked on the study with Dr. Dhruva.
The Reports Continue
Following that hard-won hearing, the FDA announced in February several new requirements, including new product labelling, and a “Patient Checklist” designed to help physicians improve their methods of explaining the device’s risks to patients. Most notably, the FDA has ordered Bayer to conduct a new study investigating the device's safety — although the device remains on the market.
The FDA, for its part, has been receiving reports about Essure-related problems since it was approved through its Manufacturer and User Facility Device Experience database, or MAUDE for short. The database is available for manufacturers, physicians, patients, and consumers of medical devices to report adverse events, such as injuries, malfunctions, or death. The reports are mandatory for manufacturers and voluntary for consumers, patients, and healthcare professionals. Depending on the severity of a case, the FDA may choose to investigate further, but confirming the reports is difficult, especially in the case of Essure.
The number of reports may be increasing due to media attention and the growth of the Essure Problems Facebook group. By the FDA’s count, between November 2002 and December 31, 2015, the MAUDE database received 9,900 reported incidents related to the Essure device, including 26 reported deaths. Most of these were voluntary reports made by Essure patients, the FDA says on its website.
A Refinery29 dive into the reports found that the incidents ranged from pregnancies to much more severe issues: Essure coils have reportedly perforated amniotic sacs and induced early labor. One baby was born with underdeveloped lungs. Two women died of blood clots, one after having a hysterectomy and the other after doctors attempted to insert her Essure coils, according to the text of the reports found in the MAUDE database.
Some of the MAUDE reports contain tragic narratives. According to a particularly harrowing report that was filed in September 2015, a woman found out she was six weeks pregnant after she had her Essure implanted in 2012. Worried about the health of her baby, she consulted her doctor about the risks. She was told that the coils would “bend out of the way and they would not cause any harm to my pregnancy."
At 22 weeks, she got up to go the restroom and heard a loud popping sound, "like a balloon.” Water started trickling down her legs immediately afterwards. She went to the emergency room and found out that she was leaking amniotic fluid.
While in the ER, the doctors attempted to stitch her cervix closed, which is known as a cerclage procedure, to try to save the pregnancy, but it didn’t work. She continued to leak amniotic fluid, and a few days later tests revealed her baby would not survive, the patient stated in the report.
Back at the hospital, a doctor was removing the stitches from the cerclage procedure so she could deliver when he found an Essure coil in her vaginal tract. “What the (profanity) is an Essure coil doing in her vaginal tract?” the doctor reportedly said.
It was too late to end the pregnancy in abortion, and so she delivered the baby, whom she named Daphne, shortly after. She and her husband held Daphne in their arms until she died 15 minutes later. “I had to bury my baby because of a coil,” the patient stated in the report. “I now suffer from PTSD because of the traumatising nature in which this all happened.”
Many of the reported incidents, including the one above, are not investigated by Bayer or the FDA. If the patient or her physician doesn’t provide the actual coil, so it can be inspected, the cases are considered inconclusive. “It is not possible to determine if a device malfunctioned if the device is unavailable for inspection,” explains DiFlumeri, the Bayer representative.
Physicians who support the Essure device say that complications are often impossible to predict. “There are certain people that will have odd reactions to drugs or surgeries or an odd occurrence during surgery that’s not well-documented,” says Cindy Basinski, MD, an Ob/Gyn in Indiana and a paid Bayer consultant. (ProPublica’s “Dollars for Docs” estimates Bayer has paid her $35,364.) “It doesn’t happen enough for us to understand how to predict it or even how to counsel patients about it.”
Despite the alarming number and nature of reports, it is important to note that some MAUDE database reports on Essure are incomplete. Some reports are duplicates. Others are mislabeled. And even up to now, some adverse event reports are mistakenly being filed under Conceptus, Essure’s previous manufacturer, by voluntary reporters. It is very hard to confirm whether each of these are valid, and truly related to Essure.
What’s undeniable, however, is that many of these women have a story about a complication they believe is related to the Essure device. The reports and the Facebook posts keep coming in — every day. And their stories really do raise important questions.
Meanwhile, Essure Problems has grown to become a highly organised advocacy group. And Essure has gained significant attention from the media thanks to them. Women post pictures of themselves in medical gowns, holding signs saying they are “E-Free,” after getting their Essure coils removed. They post pictures of their “E-Babies,” or babies reportedly born from mothers implanted with Essure. And they seek advice and comfort from other Essure women by posting their symptoms and personal stories.
Julio Novoa, MD, an Ob/Gyn based in El Paso, TX, spoke at the FDA hearing and said that the true number of adverse event reports could exceed over 25,000. He said that many women aren’t even aware of what the FDA MAUDE database is, so their complications potentially related to Essure won’t ever be reported.
“Data collection from Essure Problems surveys lists over 500 unintended pregnancies with ectopic pregnancies, and Essure-induced abortion rates as high as 40%. Further, Essure-related salpingostomies [a surgery to clear the fallopian tubes], salpingectomies [surgery to remove the fallopian tubes], and/or hysterectomies now average over 100 cases per month, with 11 cases being done just today,” Dr. Novoa said at the FDA hearing.
He originally joined the Essure Problems Facebook group to defend Essure, but after three days of looking into the complaints, Dr. Novoa changed his opinion. “My change of heart happened very quickly.”
In his point of view, even if these events are as rare as Bayer contends, another issue is that there is no information about what to do when something does go wrong. “We’re all in the dark with this. It’s basically trial and error,” Dr. Novoa says, adding that “there should be instructions from Bayer about how best to deal with complications.”
What Happens Now
For now, Essure devices are still being implanted. Proponents of Essure say the complaints should not undermine the device. Women should be aware of the risks and benefits of Essure and free to choose it, says Dr. Basinski. “My hope is that the FDA will support continued improvements in counselling to patients; that’s important.”
The FDA now requires that Bayer provide the agency’s strictest “black box” warning, which will alert patients of the risks associated with Essure. In addition, Bayer must develop and conduct a new post-market study that will investigate the rate of complications including injuries, pain, unplanned pregnancies, and surgery to remove the device. The public has until May 3, 2016 to comment on the “black box” draft guidance it issued in February.
Meanwhile, the push to ban the device remains. Rep. Mike Fitzpatrick, R-Pennsylvania, is leading the ban on Essure with his bill, the “E-Free Act.” The bill would require the FDA to withdraw its approval for Essure. On December 10, 2015, Fitzpatrick addressed Congress on behalf of the women harmed by Essure: “Their stories are real, their pain is real, and their fight is real,” he said.