Should you have right to sue if medical device makes you sick?

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(Source: CBS and 3TV/CBS 5) (Source: CBS and 3TV/CBS 5)
Implantable Essure birth control device (Source: Bayer) Implantable Essure birth control device (Source: Bayer)
PHOENIX (3TV/CBS 5) -

Some Arizona women are in Washington, D.C. right now, lobbying lawmakers for your right to sue if a medical device makes you sick.

Holding signs that ask "What is an acceptable number of deaths?" they chanted, "We need Congress to restore our rights."

Dozens of women who have found a common cause connected through social media and flew from all over the country to put faces to this fight as they met with lawmakers and protested outside the nation's capital.

The Food and Drug Administration fast-tracked 157 so-called life-saving medical devices, everything from breast implants to heart defibrillators, to get them to market faster.

[RELATED: Former Playmate of the Year on removing breast implants: 'I literally thought I was dying']

Because of that, the companies that make these Class III devices are protected by the FDA from getting sued by patients in court. And a lot of patients have come forward saying these devices gave them cancer or made them very sick.

Advocates are drumming up support for H.R. 2164, the "Medical Device Safety Act." If passed, the measure would amend the Federal Food, Drug, and Cosmetic Act to give people the right to let a jury decide if these companies could have done more to protect the public.

Michela Boodry from Mesa recently got her implantable Essure birth control device removed. She says the coils punctured her organs and caused chronic, debilitating pain.

"We just want our day in court," she said. "We're not asking for money. We're not asking for funds. We're asking for our rights to be restored. It's just a small little segment of these 157 devices that are protected where these companies aren't held to any standard."

[READ MORE: Women turn to Congress, courts to recall Essure (Nov. 21, 2016)]

[RELATED: New FDA warning issued for birth control (March 3, 2016)]

Bayer, the company that manufactures Essure, just last week, stopped making and selling Essure in every market worldwide, except here in the United States.

[CBS NEWS: Bayer halts sales of Essure sterilization implant outside of U.S.]

"That’s just a slap in the face. Do our lives not count?” Boodry asked.

Her group, Essure Problems, has worked closely with industry insiders tracking death and injury reports for medical devices reported to the FDA.

Since 2008, there’s been a six-fold increase in death and injury reports submitted to the FDA.

So far this year, 3,614 patients with Class III devices have died, and 86,234 say they’ve been hurt.

The FDA says the increase can be attributed to them doing a better job helping patients file reports.

"The FDA gets 65,000 reports of adverse events tied to medical devices a month," Boodry said. "They simply cannot keep up, and yet, they are the ones supposed to be holding these companies accountable. There is no accountability and no incentive for these companies to do anything to improve their devices or make them safer for patients."

We reached out to the Medical Device Manufacturers Association about this legislation President Mark Leahey said,

“The FDA represents the gold standard when it comes to providing safe and effective medical technologies for patients and providers," Mark Leahey, the organization's president, said. "Replacing the expert opinions of scientists, physicians, engineers and the trained professionals at the FDA who have dedicated their careers to patient safety with the lay opinion of a jury is simply not prudent."

Boodry says if they are so sure of their devices they should be more willing to defend them in a court of law.

For a more in-depth look at the Essure debate and fight for equal protection for patients in the courts click here.


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Nicole CritesNicole Crites anchors "Good Evening Arizona" weeknights 4 p.m.-6:30 p.m. on 3TV with Brandon Lee.

Click to learn more about Nicole.

Nicole Crites

The two- time Emmy award winner has been telling stories about Valley newsmakers and trends for more than a decade. Before joining 3TV's "Good Evening Arizona" team, she was the morning news anchor at KPHO-TV in Phoenix.

Nicole loves meeting new people every day and finding ways to bring context to news unfolding in our community and our world.

A wife and mother of two little ones, Nicole is always exploring Arizona to uncover exciting adventures to share. She grew up in a big family, one of six kids in Tucson.

She graduated from the University of Arizona. Work and early internships took her from Manhattan to Spokane, WA, back to Arizona, where she and her high school sweetheart settled to start a family.

Nicole loves to read and keep busy with community service and crafts, like quilting baby blankets, something her mom taught her in elementary school.  

Nicole's passion for storytelling and helping others is why she got into journalism.

She won an Emmy for her field anchoring of the deadly Tucson shooting and assassination attempt of then-Congresswoman Gabrielle Giffords and another for her KPHO "Keeping the Promise" series on military struggles and success profiles.

She is an active board member for the nonprofit, Military Assistance Mission, supporting our Arizona military, their families and wounded warriors.

She believes everyone has a story and says the most interesting people she has interviewed weren't the actors or politicians who've been guests on the show over the years, but the "ordinary" people you'd never guess have overcome extreme odds and are doing extraordinary things every day

If you have a story you’d like to share with Nicole, click here to email her.

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