FDA calls for new warnings on Essure contraceptive device

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The U.S. Food and Drug Administration said Monday that a new "black box warning" label is warranted for an implantable contraceptive device, Essure. A black box warning is "designed to call attention to serious or life-threatening risks," according to the FDA website.

The agency also called on the device maker, Bayer, to conduct surveillance that will assess "risks of the device in a real-world environment."

Essure is a permanent form of birth control in which a coil is implanted, nonsurgically, into the fallopian tubes. Scar tissue is supposed to form around the device to prevent sperm from reaching eggs and fertilizing them, thus preventing pregnancy. Women are instructed to use alternative forms of contraception during the three months it takes for the scar tissue to form.

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"The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health," according to a press release.

The FDA is also asking for a checklist for patients and doctors to sign before the device is implanted, including agreeing to a test three months after implantation to make sure the device is properly in place and functioning as intended. A checkup at that time is already recommended, but patients don't always follow through.

Monday's announcement comes after more than 5,000 women filed complaints with the FDA between November 2002 and May 2015. The reports included unintended pregnancies, stillbirths and severe pain and bleeding.

The FDA said its actions will increase understanding of the risks associated with the device for patients and doctors.

"They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications," said Dr. William Maisel, FDA deputy director for science and chief scientist at the agency's Center for Devices and Radiological Health.

In September the agency held a hearing in which some of those who filed complaints described what they went through. The FDA also heard from Bayer and health care providers about the existing body of safety data for Essure.

In November the FDA said it would release a safety review of the device this month.

Last week, Congress sent the FDA an independent study documenting 303 fetal deaths among women who used the device, saying the FDA underestimated their number.

In the past, Bayer has said the device is 99% effective at permanently preventing pregnancy. It blames the unintended pregnancies on patient error, suggesting patients may have been lax in following up with their doctors for three-month checkups to make sure the device was working, or lax at using backup birth control during the first three months.

CNN has reached out to Bayer for comment but has not yet heard back from the company.

The FDA guidance announced Monday now has a 60-day comment period to gather feedback from the public and industry.

Read more here.

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