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Popular birth control receives new guidelines for warning women on side effects

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(Courtesy Bayer via CNN)

HOUSTON – Tens of thousands of women have complained about painful side effects associated with a popular birth control device that’s been on the market for years.

Now the food and drug administration is taking action – to address the growing concern about adverse reactions to the device called "Essure."

Health reporter Haley Hernandez has been tracking this story for nearly three years and tonight she’s revealing the changes coming for doctors and patients.

Complications during her fifth pregnancy led Janie Garcia to consider getting her tubes tied.

"It's not that I didn't want it anymore, I just couldn't take it anymore," says Garcia. 

Garcia says her doctor suggested Essure instead. 

Essure is a permanent birth control procedure which places soft flexible coils into the fallopian tubes to create what manufacturer Bayer says is a "Natural barrier against pregnancy."

"I was told there were no hormones associated with it. There was no incisions and they said there was no downtime. I was gonna have the procedure and I should be back up the next morning," says Garcia. 

But Garcia says immediately after the procedure she knew something was wrong.

"I was in so much pain. I felt like there was something stabbing me in my abdomen. The headaches, the rashes, the back pain, anxiety. It was just a whirlwind of different issues," says Garcia. 

Janie eventually had the coils removed at the age of 31, and she had a hysterectomy.

Through 2017, more than 11,000 women nationwide had reported adverse reactions to the FDA. And back in February 2015, Channel 2 investigates revealed the growing number of complaints -- speaking with this group of Houston-area women who wanted Essure pulled from the market. The women say they experienced pain, hair loss and weight gain. One woman even got pregnant with Essure implanted.

On April 9, the FDA took action by issuing a ruling restricting the sale of the device and requiring patients to receive risk information first.

"With this ruling, it's really just reinforcing, by really laying it out in clear language, and the checklists that they want us to go through. And I think that also by having something written down, there's something very educational about that for women to be able to take a look," says Dr. Andrea Harvey Mass of the Women's Hospital of Texas.  

Harvey Mass is not Garcia's doctor, but she has performed the procedure on patients with positive results.

She says she welcomes this new ruling. It also requires a checklist to be signed by both patient and doctor, and more warnings about possible side effects.

Garcia hopes these new guidelines will prevent other women from suffering the same fate she and so many others did.

"I really think this is right step in the direction and I really hope that Bayer does the right thing," says Garcia. 

In 2016, the FDA issued a "box warning" for Essure informing patients of persistent pain and allergic reactions in patients. The FDA reports a 70 percent decline in the use of Essure after that black box warning was issued.