Thousands of women across the country are asking the FDA to take Essure off the market.
Essure is a non-surgical, non-hormonal permanent birth control, and is 99.8 percent effective for women who don’t want any more kids.
However, after experiencing severe side effects and even getting pregnant, KFOR reports that some women question the safety of the popular birth control.
Here's how it works: Essure is inserted into the Fallopian tubes, where tiny metal coils are implanted by a gynecologist in the doctor’s office. After several months, uterine tissue grows into the metal coils, blocking conception.
Some of the side-effects have included joint pain, chronic fatigue, weight gain, irregular heavy menstrual cycles, migraines, hot flashes, hair loss, and severe pain.
Also, many women have Essure coils which have migrated to other areas of their bodies, cutting through internal organs in the process.
Sarah Payne got the Essure coil implants in 2010.
Though the procedure is supposed to be relatively painless, Payne said it was the most excruciating pain she’d ever felt.
“It was like a ripping.” Payne said. “When you stand up it feels like someone’s taking your muscles or your insides and trying to pull them apart. It would take me to the floor.”
She believes inflammation from the metal coils sent her into early menopause.
After calling her doctor and others to report the trouble and severe pain after getting Essure, they all suggested a hysterectomy.
“He said, ‘Your only choice is to have a hysterectomy, and then we’re going to put you on bio-identical hormones.’ And all I could think about was more pills.” Payne said.
Victims of Essure have come together on Facebook, posting pictures and sharing nightmare stories about their side-effects of what they call "e-hell."
Activist Erin Brockovich also joined the fight by launching a website for women who have suffered because of Essure.
The most surprising part about this whole issue with Essure is that none of these women have a chance at a lawsuit against the makers of Essure.
The company that invented Essure, Conceptus, is now owned by Bayer, and claims that they did rigorous testing before releasing their permanent birth control implant.
Conceptus got premarket approval (PMA) which preempts future lawsuits, meaning that women who have injuries because of Essure have no way to get compensation from the company.
An expert in this area of law, Attorney Noble McIntyre calls this process “profits over people.”
“What the FDA says is if a product has gone through that level of premarket approval, and all the testing and all the literature, we the FDA say it’s safe. We (the FDA) approve it for use. Then that company has a product that is preempted from litigation, essentially exempted. You cannot sue them.” McIntyre told KFOR.
According to the FDA, about 750,000 women have the Essure implant. 943 have reported an adverse side-effect on FDA.gov.
The FDA took a closer look at the reported problems and found no direct evidence those problems were caused by Essure.
“Essure was approved by the FDA in 2002 and has more than a decade of research and development behind it. It does what it is intended to do, provide an important alternative to tubil ligation.” said Bayer spokesperson Edio Zampaglione. “The fact is, that the adverse events that have been reported on the news and online about Essure are known and are listed in the Essure product information.”