‘We want to make our voices heard:’ Women battle FDA over contraceptive device they say made them sick – By Vikki Ortiz Healy (Chicago Tribune) / May 8 2018
Dara Leinfelder had an Essure device implanted and had a severe reaction. It had to be removed and in 2014 she underwent a hysterectomy due to the problems she incurred. (Stacey Wescott / Chicago Tribune)
At 26, Dara Leinfelder had a toddler and two babies in diapers. After she and her then-boyfriend agreed they were done having children, the Bolingbrook mother considered options for permanent birth control.
At her gynecologist’s office in October 2015, Leinfelder for the first time heard about Essure, a medical device designed to permanently prevent pregnancy. A small, coil-shaped insert, which contains no hormones, could quickly be placed into each of her fallopian tubes, and she could be back on her feet the same day, Leinfelder recalled.
But immediately after the Essure inserts were placed, Leinfelder felt intense cramping and bloating in her abdomen. She woke up the next morning with painful blisters covering her legs, hips and feet, she said. Leinfelder, who had to have a hysterectomy at 27 to end the side effects caused by an allergic reaction to the nickel used in the inserts, eventually would become one of more than 35,000 women across the U.S. urging the Food and Drug Administration to take Essure off the market.
In a grass-roots movement joined by environmental activist Erin Brockovich, tens of thousands of women pleaded for years with doctors, legislators and the federal government to be heard: They were suffering from painful side effects caused by the contraceptive device, they said, including uterus perforations, pelvic pain and migraines.
This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. (AP photo)
Last month, this national movement of women, who rallied together through Facebook groups and call themselves “E-sisters,” scored two major victories.
The FDA ruled April 9 that health care providers can no longer implant Essure unless the doctor and patient review an FDA-approved document outlining the risks, and the patient has an opportunity to sign it. The following week, the FDA took the additional step of announcing new guidelines for how it approves medical devices for U.S. patients. The Medical Device Safety Action Plan was announced three days before a documentary premiered at the Tribeca Film Festival called “Bleeding Edge,” which chronicles complications resulting from medical devices — including Essure — and procedures that received little or no testing.
The film features Illinois woman Amanda Dykeman, of Orion, who also experienced painful side effects after an Essure placement and became a leader in the national movement, along with Leinfelder.
Leinfelder gathered data, collected testimony and counseled nearly 100 women who complained about unwanted pregnancies, hysterectomies and debilitating side effects from Essure. Dykeman compiled research, lobbied legislators and traveled to Washington, D.C., to meet with FDA officials in 2015 and the FDA commissioner earlier this year.
“People’s lives big and small have been affected tremendously, and their quality of life taken away from them,” Dykeman said. “That’s why I kept fighting. I knew it was just the right thing to do.”
The FDA is carefully monitoring the risks and benefits of Essure, said Deborah Kotz, a spokeswoman for the agency. As new information becomes available, the FDA will keep the public informed, she added.
“I’ve personally had the opportunity to meet with several women and hear their important concerns about this product,” FDA Commissioner Scott Gottlieb said in a statement when the restrictions were announced. “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Still, Essure remains on the market. And for hundreds of women in Illinois and across the country, the FDA’s actions are too little, too late, as many are stuck with the very thing that they say is making them sick.
Without clear guidelines on how to remove the device, many women with Essure inserts are struggling to find doctors who are familiar enough with Essure and its potential side effects to diagnose and treat problems, or insurance providers willing to cover removal procedures.
Bayer, which manufactures Essure, stands by its product.
“As the FDA has repeatedly determined — after a rigorous review of the scientific evidence — Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option,” the company said in a statement.
But Dr. Brett Cassidy, a gynecologist in Yorkville, said he has performed more than 100 hysterectomies in the last two years on women who complained of Essure complications. Some patients come to him with the Essure tubes poking out through their uterus walls. In others, he found the Essure inserts nowhere near the fallopian tubes, said Cassidy, one of only a few doctors in Illinois recommended by the Essure Problems Illinois Facebook group.
Dr. Brett Cassidy, an obstetrician and gynecologist, poses at his office in Yorkville on Thursday, April 26, 2018. Cassidy said he has treated more than 100 women who’ve experienced complications from the Essure contraceptive device. (Stacey Wescott/Chicago Tribune)
By the time they find his office — usually from other E-sisters — patients are exasperated after seeing multiple doctors who either don’t believe Essure is the cause of their problems or who are unsure of how to remove the devices. In each of the more than 100 Essure removal cases Cassidy has handled, the women reported that their medical issues lessened dramatically or stopped completely after the inserts were removed, he said.
“There’s no way it is was just … the patient was crazy or was just making up symptoms,” said Cassidy, who implanted Essure devices in 110 women years ago without knowing they caused any problems.
After Cassidy began seeing a pattern of women reporting severe pain after Essure placements, he stopped offering it to patients. He also sent a letter to the 110 women to warn them about the possible side effects from the contraceptive device. About 10 percent of them called back to say they were experiencing what he described.
“I really think it needs to be banned or removed from the market in the U.S.,” Cassidy said. “I always get concerned about new devices, new medicines. It takes about 10 years to see what real risks are involved.”
Essure is a small, flexible metal coil — made of the same material used in some heart stents — placed in each fallopian tube. Insertion takes an average of 36 minutes. Over the next three months after placement, the device works with a woman’s body to form a natural barrier that keeps sperm from reaching eggs, preventing pregnancy, the website says.
Since it was approved by the FDA in 2002, more than 750,000 women worldwide have chosen Essure for permanent birth control, which is more than 99 percent effective at preventing pregnancy, according to the Essure website.
Last fall, Bayer stopped selling Essure outside the U.S. for commercial reasons, the company said, not concerns over product safety or efficacy.
Before it became available to U.S. patients, Essure was required to get “premarket approval,” the FDA’s most stringent requirement for devices, said Kotz, of the FDA. In screening applications, the FDA balances the opportunity to provide the latest innovation to patients with keeping them safe, Kotz said.
The manufacturer had to provide the FDA with the results of myriad nonclinical laboratory studies, including experiments that tested the strength of the coils and how the nickel and other materials reacted over time. The application also required the results of clinical studies, including safety and effectiveness data, information on adverse reactions and complications, device failures and replacements, patient information, patient complaints and other results, Kotz said.
Before being able to order Essure for patients, doctors are required by Bayer to undergo several types of written and practical training, which culminates with being observed inserting Essure in five patients, said Courtney Mallon, deputy director of communications for Bayer.
The FDA has the authority to ban a medical device if it finds that the device presents “a substantial deception to patients or users about the benefits” or “an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling,” according to the agency.
But the FDA rarely acts on this authority, Kotz said.
“When we’re little, we’re taught to believe that the government and the FDA have our best interests in mind and they keep us safe,” Leinfelder said. “My faith has been so shaken.”
Years after Essure made it to doctors’ offices across the country, Dykeman and her then-husband decided their family of five was complete with three boys.
Dykeman, a stay-at-home mom at the time, opted to get Essure inserts because she liked the idea of a procedure that wouldn’t keep her from running her busy household. But soon after they were inserted, she began having irregular and uncomfortable periods. Other symptoms followed, including hair loss, joint pain and migraines so severe she would force herself to vomit to alleviate the pain, she said.
While searching for answers online, she stumbled across the Essure Problems national Facebook page created in 2011 by another former Essure patient living in New York, Angie Firmalino. Conversations with Firmalino and other active group members gave Dykeman the knowledge and confidence to seek out a hysterectomy — removing the Essure inserts along with her uterus and fallopian tubes — which ended her medical issues immediately, she said.
After the experience, Dykeman felt so passionately about spreading the word about Essure’s potentially dangerous side effects that she became an administrator for the national Facebook group. Along with a core group of about 15 women nationwide, the E-sisters organized rallies at annual conventions of the American College of Obstetricians and Gynecologists. They met with local lawmakers, counseled women dealing with Essure complications by phone and in person, and in September 2015, offered emotional testimony before an FDA panel investigating the safety of Essure.
“It was a very tearful event. The stories that you heard were just heartbreaking,” said Dykeman, who recalled E-sisters speaking into the microphone about miscarriages, having portions of their organs removed, and being so ill their children had to take care of them. “We just went to plead with them and tell them it was not safe.”
A year later, the FDA recommended that Essure include labeling on its boxes that warned of potential complications. The government agency also determined that a Patient Decision Checklist be given by doctors to patients to better communicate risks. Last month’s ruling went a step further by mandating that doctors review the risks and offer patients a chance to sign the document.
Meanwhile, the E-sisters continued to counsel new group members, collect data and connect with lawyers. As of today, there are more than 16,000 plaintiffs in lawsuits in the U.S. filed against Bayer in relation to Essure, according to Bayer’s 2017 annual report.
A spokeswoman for Bayer said some lawyers and health care providers are trying to make money off of unsubstantiated complaints about Essure. “What is extremely concerning is these cottage industries taking advantage of women and preying on their fears,” Mallon said.
Although the FDA’s most recent actions stop short of banning Essure altogether, Dykeman and Leinfelder said they feel vindicated that women will no longer be unaware of the dangers before an Essure insertion.
But work still needs to be done to spread the word about what has happened, so women dealing with complications will not have to fight with their doctors to make them believe that a medical device could be the root of their problems, they said. The E-sisters are working to find places where the film “Bleeding Edge,” produced by Netflix and directed by Kirby Dick, who won critical acclaim for “The Hunting Ground,” can be screened for wide audiences.
“We haven’t given up; we want to make our voices heard,” Leinfelder said. “The biggest way to get somebody’s attention is to make a nuisance of yourself. They can’t ignore you when you’re shouting and knocking on their doors.”
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