ROCK ISLAND, Ill. - There's a contraceptive device for women generating some controversy across the country.
It's called Essure.
It's a device that's the only permanent non-surgical form of birth control for women in the United States.
It's a flexible coil device that's implanted into a woman's fallopian tubes.
The device was meant to be a form of birth control that hit the market in 2002 but now, it's the source of thousands of complaints, including punctured uteruses and persistent pain.
Amanda Dykeman of Orion, Illinois, says women deserve better.
"I was a busy mom and I was told there would be no downtime, back to my busy day like the same day, so it just sounded like the best choice for me."
But what she thought was her best choice for birth control ended up being a health nightmare.
"I was never warned about anything, any complications that could happen in the future."
"Migraines, very weird, irregular menstrual cycles, I just felt like something was off, I wasn't feeling like myself."
Dykeman still considers herself one of the lucky ones.
In 2016 alone, nearly 12,000 reports were filed with the FDA, including experiences of women who needed hysterectomies to get their devices removed.
"We've seen some pretty horrific things," says Dykeman.
In 2017, the FDA required Bayer to include a boxed warning with Essure.
And in April of 2018, the agency restricted sales of the device.
The group is also requiring doctors to review and sign a checklist with patients before the implant.
But Dykeman says it's not enough.
"It's not worth the risk, it's not worth continuing to put women in harm's way."
Dykeman is one of more than 16,000 women who are suing over Essure.
"Essure has been withdrawn from the market in every other country other than the United States," she says.
Dykeman wants it off the market until the device undergoes more clinical testing.
"If this product was designed for a man, it would've been pulled from the market already, in my opinion. We've seen clinical trials of different contraceptives already for men and the minute they start showing symptoms that some of us women are expected to endure just for birth control, the clinical trials were halted."
Dykeman's story is highlighted in a documentary called The Bleeding Edge
It premiered at the Tribeca Film Festival and will hit Netflix next month.
You can find out more about the film by clicking here.
If you've been affected by Essure, you can find resources by clicking here.
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