The FDA has updated their ongoing safety review of Essure, a permanent sterilization implant made by Bayer. Essure is now linked to more than 10,000 reports of serious injuries and dozens of deaths.
Brazil has banned sales and recalled Essure, a non-surgical sterilization device linked to 10,000 injuries. No recalls have been issued by the FDA, despite 900 lawsuits and a massive grassroots campaign in the United States.
Thousands of women have spent years trying to get Essure off the market due to safety risks. Instead of a recall, FDA has strengthened warning labels and created an optional "Patient Decision" checklist.
Bayer is facing several lawsuits after more than 5,000 women were injured by Essure birth control.