Advocacy group calls for FDA action on Bayer's birth control device

A patient advocacy group is calling on the Food and Drug Administration to take action against Bayer Healthcare's Essure sterilization coils as women continue to be harmed by the product, according to the The Philadelphia Inquirer.

Here are five things to know.

1. Surgeons implant the flexible metal coils into a woman's fallopian tubes. After three months, tissue grows around the coils, blocking sperm from reaching eggs, thereby preventing pregnancy.

2. The FDA has received reports of more than 9,000 removals of the birth control device since 2009 due to complications such as bleeding or pain, along with reports of adverse events such as miscarriages and fetal deaths, according to a Device Events analysis.

3. Essure Problems, a 37,000-member patient advocacy Facebook group, said the FDA received 2,000 reports of women undergoing surgery — mostly hysterectomies — to remove the coils in the first quarter of this year, according to the report.

"We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?" Angie Marie Firmalino, cofounder of Essure Problems, told

4. The FDA added a box warning to Essure's label in November 2016 to alert consumers of risks associated with the device and created a patient decision checklist for women considering its use. However, about 200 women contacted Essure Problems over the last six months, saying their physicians did not inform them of the warning label or use the checklist, according to the report.

5. The FDA told the Inquirer it "continues to review the available information about Essure, including reports of problems submitted to the [agency]."

Bayer told the publication: "We take all adverse events seriously … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.

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