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Essure Issues: Women Wait for FDA to Release Findings for Birth Control Method

Posted on Feb 05, 2016

Essure is a device owned by Bayer that doctors implant into a woman's fallopian tubes, which prevents conception. Marketing for the product says it's a non-surgical process that's been around since 2002. Over the past several years, however, the U.S. Food and Drug Administration has received multiple reports of the device causing problems. The FDA is actively evaluating the product after an intensive panel meeting in September and plans to announce its findings at the end of February.

Women claim they have all kinds of side effects from this device that they weren't told about when doctors implanted the device and aren't listed as risks with Essure. One Cedar Rapids woman just had a hysterectomy due to what she said are complications with the device. "I'm still processing all of this. I'm still thinking about why this is even happening,” said Brittany Dougan.

What's happening to Dougan all started in 2009."When I had my last child I decided I didn't really want anymore,” Dougan said. The mother-of-three talked to her doctor about Essure and got it implanted shortly after. "Six months after the procedure, I noticed that I was feeling not normal, very lethargic, very fatigued, I was tired all of the time. So, I was up at the University trying to seek answers as to why I was feeling these ways,” Dougan said. Dougan said after thousands of dollars of medical bills stacked up, one OBGYN mentioned Essure might be her problem. He directed her to a Facebook page where about 25,000 women are sharing their symptoms, which sounded familiar. "Chronic fatigue, bloating, severe bloating - sometimes some of us women, there are days you look six months pregnant and you are not. Headaches, we call it a brain fog, but it's just confusion,” Dougan said. Dougan filed a complaint with the FDA. The agency said it has received more than 5,000 formal reports of issues with Essure since it was approved in 2002.

"We deploy these coils so that the tail of the coil is into the uterus. The coils when then deploy along the length of the tube and this area will then form a scar,” Ward explained.

Essure's labeling warns about chronic pelvic pain and the OBGYN said that can happen in some women.

"I think it's important for women's health to keep women's reproductive rights in their hands. I think if this coil, if it’s not safe, we should not use it.

Dougan said she wants other women to know nothing good can come from Essure. She's hoping now that it's out of her system, so she can enjoy a pain-free life with her children. "I just, over the years, have not been able to do things that normal people are able to do,” Dougan said. She’s wants to make sure that Bayer and the FDA hear her stories and those of many others. "We are real people and this is happening to us and to get rid of it. Right now they are protected. Until February when they come out with their final decision there's nothing we can do, we are just sitting ducks,” Dougan said.

A spokeswoman with the FDA said the manufacturer has to submit annual reports about devices and reports of death or serious injury. She said any time a device on the market is causing problems; they review it and determine if more action is needed.

The FDA said people should know more about their review of the product by the end of February, but they wouldn’t specify a certain date.

If you or a loved one suffered tubal/uterus puncturing, bleeding, or other injuries from Essure, please call our experienced products liability attorneys at (888) 606-5297 for a free consultation about your Essure lawsuit.

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