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FDA to Take a Closer Look at Essure Birth Control Device

Image Source: Thinkstock
Image Source: Thinkstock

Thousands of women are sick with a wide-ranging host of symptoms, and they believe the cause is their birth control device.

Essure is a birth control device praised for being a less expensive and less invasive alternative to a tubal ligation (having your tubes tied to prevent pregnancy). But recently, more than 4,000 women have complained to the FDA of horrible reactions — and 7 deaths may possibly be linked as well.

Lacy Bradley, a Virginia mom of three, turned to Essure after the birth of her third child, Jolene. She and her husband decided that Jolene would be their last child, and when choosing between a tubal ligation, daily oral contraceptives, and Essure, she chose Essure.

“I was told when I got it, it was non-invasive, there was no down time, it was fast, easy, no issues,” Bradley told ABC8News. But two months after that, she woke up in the night “covered head to toe in hives” that would not respond to antihistamines. She also suffers from terrible bloating, heavy bleeding, and extreme hair loss.

Bradley would soon discover that she’s allergic to nickel (the Essure device is made from two thin, flexible coils with a nickel core and a synthetic wrap).

Seventeen thousand women have complained on the “Essure Problems” Facebook page, and 4,000 complaints have been sent to the FDA. Common complaints include severe cramping, ectopic pregnancy, and perforated uteri, in addition to hives and hair loss like Bradley described.

The FDA has been looking into the complaints and has announced that they will be holding a public meeting Sept. 24 where they will review the data and hear from patients and researchers about the reported side effects.

Bayer, the company that manufactures Essure, stands behind their product and insists that since 2002, more than 750,000 women have had the device implanted with success. They have also stressed that there is always risk of side effects with medical devices — all of which are known and listed in the Essure product information.

But Bradley claims she was never warned, and the symptoms are much more severe and wide-ranging than she anticipated. She is also unable to find a doctor willing to remove the Essure device. Her next step is filing a class action lawsuit against Bayer.

For more information about the risks and side effects of Essure, click here.

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