HOUSTON - Complications during her fifth pregnancy led Janie Garcia to consider getting her tubes tied.
“It's not that I didn't want anymore," she said. "I just...I couldn't take it anymore.”
Garcia said her doctor suggested an alternative.
It's called Essure.
Essure is a permanent birth control procedure that 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," Garcia said. "There was no incisions. They said there was no downtime. I was gonna have the procedure and I should be back up the next morning."
But Garcia said immediately after the procedure, she knew something was wrong.
“I was in so much pain," she said. "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.”
Garcia eventually had the coils removed.
And at age 31, she had a hysterectomy.
She's not alone.
Through 2017, more than 11,000 women nationwide had reported adverse reactions to the Food and Drug Administration.
And back in February 2015, Channel 2 Investigates revealed the growing number of complaints—speaking with a 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, issuing a ruling restricting the sale of the device and requiring patients to receive risk information first.
CLICK HERE FOR FDA RULING ON ESSURE
Dr. Adrian Harvey Mass of The Women's Hospital of Texas is not Garcia's doctor, but said she has performed the procedure on patients with positive results.
“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," she said. "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."
Mass said she welcomes the FDA's new ruling.
CLICK HERE for Essure “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.”
It also requires a checklist to be signed by both patient and doctor, and more warnings about possible side effects.
“The other things they've brought up are things like weight changes, mood changes, hair loss,” Mass said.
Garcia said she 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," she said. "I really hope that Bayer does the right thing.”
In 2016, the FDA issued a "black 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.
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