Permanent contraceptive may harm more than help
The Food and Drug Administration has received more than 16,000 adverse-event reports about Essure, including complaints of bleeding, hair loss and tooth decay
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.
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. 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.
Though Keisha thought she had forever taken care of birth control, the feeling that she might be pregnant kept nagging at her. 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.”
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.
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, Dr. 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.”
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.
Activism can make a difference. 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.”
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?
“It seems every two or three years we have another controversy in women’s health,” says Steve Xu, a healthpolicy 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.”
Much of the U.S. medical community continues to endorse Essure. The American Congress of Obstetricians and Gynecologists opposes the black box warning. 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.
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.”
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.
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.
Things are looking up in other ways. Mekhi quickly caught up in size to his older brothers 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.”