GREENSBORO, N.C. – Thousands of women want Essure Birth Control taken off the market. They say, the FDA-approved Essure is making them sick. It's supposed to be an easy, non-surgical alternative to a tubal ligation. But woman after woman told WFMY News 2's Tracey McCain, Essure made their lives a living hell.
Erica Davis, Anne Brumer and Nicole Newton felt compelled to speak out about their experience with the medical device Essure.
"I had terrible contractions and spasms," said Brumer. "The bleeding wouldn't stop!"
"Nothing solves your pain," described Davis.
"There's days when my migraine headaches are so bad, I don't want to come out of my bedroom. I feel like a 31-year-old stuck in an old woman's body," added Newton.
Essure is marketed as a permanent birth control without surgery. Two small metal coils are placed inside the Fallopian Tubes blocking conception. Bayer makes Essure. The company says it's safer than having your tubes tied. But these women say, 'Absolutely not!'
"It took three years of my life. I was constantly sick, with headaches and fatigue," described Davis.
Davis had Essure implanted nearly four years ago. Within the first week, she knew something was wrong.
"I looked like I was 6 months pregnant!"
She says she lived in agony for almost three years. The only way to get the coils out was extreme. At 28-years-old, the mother of two little boys had a hysterectomy.
"That's the only way I could get myself out of this pain. I had a perforated Fallopian Tube," she said. "I have no uterus, no tubes, no cervix. I couldn't have a child even if I wanted to."
Thousands of women are sharing those same stories on Facebook. On the page you see woman after woman talking about their symptoms and warning others.
"There's women on the Facebook page having hysterectomies every single day. Every day multip0le women."
That's one of the major complaints filed with the FDA since 2004. The agency logged 942 reports of adverse effects from Essure, including pain, hemorrhaging, headache and fatigue. Five hundred of those complaints were filed in the last year, citing punctured Fallopian Tubes and broken coils. Ninety-one had hysterectomies. Eighty became pregnant.
"We have essure babies every day. We call them E-Babies," said Brumer.
Brumer had her Essure removed. It left a giant hole in her left side.
"They made it sound very safe, that it would be no recovery time."
All three women want Essure taken off the shelves.
"There's got to be a message sent to the FDA and to Bayer saying there is a problem here because women are suffering," said Davis.
Essure went through five years of clinical trials. Newton said the FDA fast tracked the study.
"The FDA needs to make sure the studies go all the way through so that something like this doesn't happen again."
We called Bayer and the FDA about the complaints. They told us these claims are not outside of the possible risks discovered during the product's clinical trial and those risks are printed on the packaging.
The product's packaging also carries a warning about nickel allergy from the metal. But the FDA does not recognize fatigue, depression and weight gain to be directly associated with Essure.
None of the women who have had problems with Essure can sue Bayer because of a special status it got when the FDA approved Essure in 2002.