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FDA announces changes to Essure, permanent birth control device

This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. Federal medical experts on Monday, Sept. 21, 2015 said it will take a closer look at a host of problems reported with Essure, including chronic pain, bleeding, headaches and allergic reactions. (Bayer Healthcare Pharmaceuticals, Inc. via AP)

Breaking news in the battle over a permanent form of birth control called Essure. The Food and Drug Administration has announced changes the maker of the device will have to make moving forward. But women calling for a recall of the device say they're not happy with the decision.

After reviewing concerns submitted by women from an Essure Problems Facebook group as well as feedback and recommendations from a special panel tasked with looking at the device, the FDA is now ordering Bayer to complete a post-market study.

In its announcement, the FDA said it also intends to make the company add a boxed warning and a "Patient Decision Checklist" to ensure women receive and understand information about the risks and benefits of the device. The agency is in the process of evaluating the trade complaint against Essure.

But anti-Essure advocates say they're outraged by the FDA's decision, saying it should be pulled from the market. In a press release, representatives of the group are critical of the call for a post-market evaluation, saying, "These studies could take several years, and leaving the device on the market will only put more women's lives at risk."

7 ON YOUR SIDE has been covering risks and complaints associated with Essure dating back to 2014. Our reports uncovered thousands of complaints associated with the device and documented in an FDA database.

Bayer has long said Essure is safe and backed by more than a decade of science.

7 ON YOUR SIDE reached out to the company for reaction to the FDA's decision and received this response:

"Patient safety and appropriate use of Essure are our greatest priorities," said Dario Mirski, M.D., senior vice president and head of medical affairs Americas at Bayer. "A woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure."

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