CITRUS HEIGHTS – A new Netflix documentary exposing how one medical device may have seriously harmed some patients had an early screening in Citrus Heights Saturday.
The documentary, “The Bleeding Edge,” includes personal stories from those who’ve experienced serious issues from the birth control Essure, including some stories from local women.
They believe the device was rushed through the FDA’s tests in order to turn a profit.
April Hicks was a healthy mother of three but for five years she suffered.
"I had chronic pain. It was chronic and it was in my back," said Hicks. “My hair started coming out in handfuls, just clumps of hair were coming out. Fatigue, I was extremely tired."
Her pain was physical and emotional.
"It was scary because a lot of the doctors wouldn't listen," stated Hicks.
Doctors didn’t know what was wrong but Hicks says she eventually figured her serious health issues were side effects from Essure, a permanent birth control device. The metal coils are implanted into the fallopian tubes to stop pregnancy.
“I would not want this pain on anybody. Nobody should have to go through that" Hicks expressed.
Hicks learned tens of thousands of women shared a similar struggle after getting Essure.
Many women spoke out against Essure. Elizabeth Cox expressed her “crippling pain.” Stephanie Bogan talked about her “constant heart palpitations” and “making multiple trips to the ER.”
Angela Lynch felt like she was dying. She “could sleep for 14 hours then go back to bed.” She said she also experienced “migraines and fatigue and, you name it, I had it."
Lynch is one of the administrators of the Facebook group named, "Essure Problems."
"It`s changed lives. I see it every day. We get messages every day," Lynch said.
With close to 30,000 members, what started as a support group has morphed into a movement. It's a fight against the FDA and Bayer to get Essure off the market.
"This product is not safe, it’s not effective and I have a 1-year-old and a hysterectomy to prove it," stated Cox.
A small victory came in February 2016 when the FDA announced it will be adding a warning to its box and a patient checklist on Essure. It also ordered Bayer to conduct additional studies on the risks of the device.
Bayer told FOX40 they sympathized with those who had problems and will work the FDA.
"We see the FDA's actions today as an opportunity and a path forward to continue to gather important data about Essure and to provide physicians additional tools for patient counseling," said Dr. Patricia Carney, director of Bayer’s U.S. Affairs for Women’s Health.
The FDA acknowledges "some women experience very serious and sometimes debilitating problems" after getting Essure but insists the product is "safe and effective for many women." The FDA adds that a ban on Essure would "limit the options available to physicians and patients."
"They need to wake up and realize that this is not... there`s gotta be something different," said Lynch.
The women say they struggle to understand why the FDA didn`t do more. They say the agency failed them and is putting more women at risk with a device they consider dangerous.
For them, getting their uteruses surgically removed was the only way to get relief.
"It was horrible. My kids lost a lot of my life or I lost a lot of their life because of it," Lynch said.
They realize this is an uphill battle. Lynch said, "we’re fighting two big entities."
But they vow to keep going so women like April Hicks won’t have to spend years trying to heal from unnecessary pain, surgeries and stress.
"Hopefully since it's removed I can get back to being what I was before it," said Hicks.
Several federal lawsuits against Bayer. Last month, a judge ruled they can move forward.
Bayer says anyone with questions can speak to a specialist at 1-877-ESSURE-ONE. That’s 1-877-377-8731.
The film premieres on Netflix on July 27.