OKLAHOMA CITY — Oklahoma women question the safety of a popular birth control.
Hundreds of women say this non-hormonal permanent birth control has ruined their lives.
It’s called Essure, and it’s marketed for women who are done having children.
According to the marketing Essure is 99.8 percent effective for women who don’t want any more kids.
How It Works
Essure is a birth control device inserted into the Fallopian tubes. 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.
“It sounded like a good thing to me. I mean. I’ve got a busy life. I’ve got five kids.” said Crystal Plumlee.
Plumlee chose Essure because it was the most affordable, effective option.
“It’s not worth it.” she now says. “It might seem easier, but it’s not worth it in the long run.”
Plumlee now has joint pain, chronic fatigue, weight gain, irregular heavy menstrual cycles and debilitating headaches.
“There are some people who are having success with it, but I would not want to gamble that. I’m not a gambler. Unfortunately this is something I gambled with, and I’ve made one of the biggest mistakes of my life.”
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.”
Soon after Essure Payne started getting migraines, hot flashes, night sweats, hair loss and severe pain.
She believes inflammation from the metal coils sent her into early menopause.
Payne called her doctor and others to report the trouble after she first got Essure.
They have 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.
There are now thousands of women across the U.S. who are begging the FDA to pull Essure off the market.
The women have come together on Facebook, posting pictures and sharing nightmare stories about their side-effects.
Many women have Essure coils which have migrated; moved to other areas of their bodies, cutting through internal organs in the process.
They call it “e-hell.”
Also, several hundred Essure patients have gotten pregnant with so-called e-babies after Essure.
Recently famous activist, Erin Brockovich joined in the fight.
Brockovich launched this website for women who have suffered adverse effects because of Essure.
“So we have a device that`s intended to be permanent birth control, but women are getting pregnant on it.” Brockovich said during this webcast with Marlo Thomas:
Perhaps the most surprising part about this whole issue with Essure is that none of these women has any chance at a lawsuit against the makers of Essure.
The company that invented Essure, Conceptus, which is now owned by Bayer, claimed they did rigorous testing before releasing their permanent birth control implant, Essure.
Conceptus got what the FDA calls premarket approval (PMA) which preempts future lawsuits.
In other words, women who have injuries because of Essure have no way to get compensation from the company.
Mass tort attorney, Noble McIntyre calls this process, “profits over people.”
According to McIntyre, who is an expert in this area of law, the complaints against Essure continue to pile up.
“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 said.
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.”
Here is the video statement released by Bayer:
Search FDA.gov for adverse event reports