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FDA puts warning label on Essure, doesn’t pull it from shelves

The Food and Drug Administration (FDA) has put a “black box” label warning on the controversial permanent birth-control device Essure, in addition to undertaking other safety precautions, but it is leaving the product on the market, according to The Washington Post.

Essure, produced by the German company Bayer AG, has come under fire in recent months for causing persistent problems in some women, including irregular bleeding, pelvic pain and mood disorders, to the point where some devices had to be surgically removed, as discussed previously on this blog.

 

 

After facing consumer outrage, the FDA investigated Essure and its potential side effects in the past few months, and has instituted a “black box” warning about possible complications from the device. In addition to the warning, the FDA has plans to create a checklist of potential risks that doctors should discuss with patients before recommending Essure. The FDA is also instructing Bayer to conduct a clinical study to further assess the device’s safety and risks.

The agency’s decision to not take more forceful action on Essure, including pulling it from the shelves, drew criticism from around the country, including from groups of women who have spoken out against the product’s effects. In particular, some consumers are disappointed that the device is still being sold as a viable option for permanent birth control despite reports that some 631 women became pregnant after receiving the Essure implant, per the Washington Post. Essure, first approved in 2002, has consistently been hailed as a safe and permanent alternative birth control method by Bayer, remarking that it has a 99% chance of effectiveness.

However, the decision from the FDA can seem particularly harrowing to the thousands of consumers around the U.S. that expect the agency to act as a safeguard against potentially dangerous products and their side effects. Many consumers are liable to feel that defective products are left on the market for too long before they are pulled, even when the evidence seems to point toward their risks. 

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