Women Lobby FDA To Ban Birth Control Device

A group of activists plan a hunger strike in an attempt to get a birth control device off the market

Sep 06, 2015 at 8:56 AM ET

Later this month, 35-year-old Angela Desa-Lynch plans to go camping—at the Food and Drug Administration. She will pitch a tent and roll out a sleeping bag in front of the FDA’s Washington D.C. headquarters, along with a couple dozen other pillow-toting friends. There, they will be conducting a hunger strike. The goal is to get the agency to remove from the market Essure, a medical device that they believe is hurting and even killing women.

“We’re just gonna stay there,” she says. “After five days is over, we’ll give them a couple months, and if they don’t pull Essure from the market, then we’re coming back and we’ll do it again.”

Essure is a metal spring that is inserted into each fallopian tube. It causes scar tissue to grow, which eventually blocks the entrance of sperm or movement of the egg. It’s the only permanent non-surgical birth control option approved by the FDA and as such it has been heralded as a major breakthrough for women’s reproductive healthcare.

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Not everyone sees it that way. Desa-Lynch is one of nearly 20,000 women who belong to the Facebook group “Essure Problems.” The majority of its members have or used to have Essure and claim that it caused them a host of debilitating medical problems, ranging from hair loss to swollen abdomens to perforated fallopian tubes. They also question the device’s claim of 99.83 percent effectiveness at preventing pregnancy; Desa-Lynch says there have been around 600 pregnancies among group members with Essure. (This number, which would put the device’s effectiveness at about 97 percent, may be high due to the self-selecting nature of the group. Or it may actually be low: Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine, has calculated that one in 10 women who’ve had Essure implanted would become pregnant over 10 years, according to The New York Times.)

It’s a tight-knit, highly active community with its own particular language. Throughout the day, they commiserate with their “e-sisters” about their “e-hell” and all the “e-motions” that come along with it. They share before and after photos of their “e-bellies.” They post about their “e-viction” dates once surgery has been scheduled and post “e-free” updates after the fact. Then there are the “e-babies” that they say were conceived despite Essure—and with them stories of miscarriages, abortions, birth defects and newborn death.

Recently, a peer-reviewed study recruited more than 1,000 women from the Essure Problems Facebook group to try out an app for reporting “adverse events” to the FDA. Nearly 78 percent reported “serious events,” including hospitalization and disability. The most frequent reported experiences were fatigue, back pain, pelvic pain, mental impairment, “device dislocation,” meaning the coil moved from its intended place in the fallopian tube, and salpingectomy, the surgical removal of the fallopian tube. Also of note: lost libido, metal allergies (the coils contain nickel) and hair loss. The researchers also found suicidal ideation among 14 of the women and two suicide attempts. (A long-term study of Essure recently reported that 99 percent of participants evaluated their comfort with the device as “good” to “excellent.” Most “adverse events” reported by the participants were rated as “mild” or “moderate.” Three “severe” events were reported—abdominal pain with heavy periods and irregular menstruation—in only two participants.)

“I hurt so bad I couldn’t get out of bed. I just felt like, ‘I’m dying. I don’t know what this is, but it’s killing me.'” — Angela Desa-Lynch, former Essure user

The FDA, which has received 5,093 reports related to Essure, has noted some similar findings. The most frequent complaints were pain, heavier or irregular periods, headaches, fatigue and weight change. The agency has also received 11 reports of deaths related to Essure: five of fetal demise and six relating to four adult deaths.

Dr. Shawn Tassone, an OB-GYN in Austin, Texas, performed hundreds of Essure procedures before he stopped in 2013. That was thanks to a call he received from a doctor in another state about a former Essure patient of his—she had moved and was in the E.R. with an ectopic pregnancy. “I started thinking, doctors don’t usually call each other and say, ‘I saw your patient,’ so it struck a nerve that maybe there’s more people out there that had more complications like this.” That’s when he discovered the Essure Problems Facebook group. Now, Tassone, who has accompanied the Essure activists to a past meeting with the FDA, only performs procedures to remove the device. “I’m seeing some pretty crazy things: distended abdomens that are gone in a few days to weeks, rashes that are disappearing, pain that’s getting better. It’s really interesting.”

That isn’t to say that he believes all of the symptoms and experiences described in the Essure Problems group can be necessarily attributed to the device. But he does believe that Essure can cause adverse effects in a minority of patients and that there should be a better way of removing it from women who are experiencing problems. “The only safe way to take out these Essures is hysterectomy,” he says, explaining that coils can easily break into pieces during removal, “and that’s a major problem.”

Desa-Lynch, a single mom, underwent the Essure procedure in 2008 shortly after having her third child. Not too long after, “little things started happening,” she says—night sweats, depression and migraines, for starters. At first, she says, “I chalked it up as, ‘Well, I just had a baby and now I got fixed and my body’s going nuts—so, hormones.’” But the symptoms kept coming, and getting worse: hair loss, jaundice, weight gain, fatigue. “I hurt so bad I couldn’t get out of bed,” she says. “I just felt like, ‘I’m dying. I don’t know what this is, but it’s killing me.'” That’s when she began investigating her symptoms online and found the Essure Problems group.

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In 2012, she decided to have the Essure coils taken out. At the time, the only way to do that was a hysterectomy. “By the time I had surgery, my biggest fear was that I wasn’t going to live through the surgery, ‘cause I was so weak,” she says. “I could barely get out of bed.” Just a few days after the hysterectomy, she says, she already felt better.

The camp-out and hunger strike will begin on September 24, immediately after a scheduled FDA panel meeting featuring anti-Essure activists as well as representatives from Bayer, the device’s maker. That is because, while the agency has agreed to hear their concerns and consider their evidence, spokespeople have publicly clarified that the FDA is not considering reversing approval for the device. “That was just it for me,” says Desa-Lynch, who came up with the idea for the hunger strike. “I was like, ‘I’m not leaving until something is done.'”

An FDA spokesperson told Vocativ that the agency is “seeking input from the panel concerning the safety and effectiveness of Essure.”

The Essure activists will be joined during the meeting by activists fighting the FDA over two other women’s health issues: transvaginal mesh and power morcellators. The first is used to treat pelvic organ prolapse, a condition in which organs bulge into the vagina, and that has been linked to conditions including chronic pain and fatigue. The latter is a surgical tool used to cut up uterine tissue for removal through a small incision, and activists argue—and the FDA has acknowledged—that it can spread previously unrecognized cancerous tissue outside of the uterus, upstaging the cancer and decreasing a patient’s likelihood of survival.

These causes have joined together in part because there is overlap between them all. Desa-Lynch points to the similarity of symptoms between the “e-sisters” and “mesh girls,” as she calls them. Essure Problems also has several women who have undergone the sterilization procedure and then, after experiencing what they believed to be negative side-effects, had the coils and their uterus removed via morcellation. At least one member has undergone all three procedures.

Desa-Lynch also argues that they have sexism in common. “In any one of those three different fights, a woman goes to the doctor and tells them what their problem is, we’re automatically written off as hormonal. We’re not listened to,” she says. “If this was happening to a man, if they had made this product for a man and 20,000 men came out and said, ‘We can no longer have sex anymore,’ I guarantee it would no longer be on the market.”

Tassone questions the cultural norms that drive women to procedures like Essure, when there are better alternatives available for men. “I think you guys get shafted on this whole—well, kind of in general—but definitely in reproductive stuff,” he says. “It’s all your responsibility to not have babies, right? The one time that a guy can actually do something is a vasectomy and nobody does that, hardly!” Tassone always tells his female patients that the best permanent method of birth control is for their male partner to have a vasectomy, a much safer and easier procedure than the equivalent surgery for a woman. “Ninety percent of time they say, ‘Well, that’s not going to happen,'” he says. Many men believe that a vasectomy will hurt their manhood, and plenty are simply accustomed to seeing birth control as a woman’s responsibility.

“We’ve always put the burden on the women,” he says, “but we also minimize them when they have complaints.”