Birth Control Backlash: Women join forces to speak out on Essure
In a small town in the shadow of Mount Rainier three strangers became friends because of the birth control procedure called Essure.
Those three friends, Shannon McOsker, Mishelle Moore and Amanda Lehr are all done with having kids and had the procedure.
During the procedure, a doctor inserts a metal coil into each fallopian tube.
Scar tissue then builds up around the coils, blocking the egg and sperm from meeting.
Shortly after having the procedure done, the women claim they suffered nightmarish side effects from Essure. They say those side effects were never disclosed by doctors, the Federal Drug Administration and the manufacturer, Bayer.
And Nicola Cook, whom KATU interviewed for a previous story, ended up with a surprise pregnancy after the Essure procedure.
Essure is touted as a safer, less expensive and less invasive alternative to women getting their tubes tied. There's no anesthesia, no incisions, no scarring. Women are typically out the door of their doctor's office in under 30 minutes.
But these women say they suffered excruciating pain.
"The constant, intense pain that doesn't go away," says Lehr.
"I had migraines. I have joint pain. My entire body hurt," says Moore.
There was also weight gain and fatigue.
"Very bloated from the bellybutton down, extreme exhaustion. You feel like you're weighted down," says McOsker.
There are other unexplained symptoms they believe stem from the nickel and other fibers in the coils.
"I'm concerned because people aren't being warned about the nickel. That's a big deal," Moore says.
Eight years after her procedure, McOsker says her pain was too much to bear.
"My tubes started feeling hotter at certain times of the month," she says. "They would, at mid-cycle, they would feel like there's a curling iron in my tube."
She had surgery to get the coils out. And during surgery, a startling discovery was made: The coil punctured one of her fallopian tubes.
"So he said, 'No wonder why you've been in pain.' And I'm like, hands in the air, 'Hello, yes, this is exactly - makes sense. Totally makes sense to me.'"
Then another shocker: The Essure implant broke into two pieces. To get it all out, doctors tell her she needs a hysterectomy.
"It's like playing Russian roulette with your insides. I just don't know what's going to happen," she says.
It's not just McOsker. Moore and Lehr have also had surgeries to get the coils out.
Moore had a hysterectomy and Lehr had her tubes tied.
They all filed complaints with the FDA. KATU found 943 filed "adverse events" with the FDA since Essure was approved in 2002.
Through it all, they say, doctors and the drug company dismissed their claims.
The FDA did admit it's reviewed reports of symptoms that were never observed in the post-approval studies.
But states, "None of the information the FDA reviewed has established a causal connection between Essure and certain reported problems, such as extreme fatigue, depression, and weight gain."
Moore, McOsker and Lehr, however, are not convinced. And they're turning talk into action. They've signed a petition started by the famed consumer activist Erin Brockovich.
"We want the FDA to re-examine this device. We want them to look at it again. Seriously look at it," says Moore.
"Women who are told that there either are no side effects or the side effects are minimal, and then have extreme side effects, and have to have hysterectomies at very young ages, they should be able to get retribution for that," Lehr says.
Women from across the country will rally this Sunday at a gynecology conference in Washington, D.C.
They're not only calling for new safety studies, the petition the women signed is meant to change the law.
As it stands right now, women who feel they've been harmed by Essure cannot sue the manufacturer, in this case, Bayer. That's because the FDA put Essure in a special class of medical devices.