The FDA has placed a new set of restrictions on the sales and marketing of a birth control device sold by Bayer.
Called Essure, the coil-shaped implant works by permanently blocking fallopian tubes, which allows patients to forgo hormone-based treatments or surgery to prevent unwanted pregnancies, abnormal uterine tube bleeding and more.
In 2016, the FDA placed its strongest safety warning on the device after reports linking it to severe pain, unintended pregnancies, miscarriages, bleeding and more. The FDA reported this week that it believes patients are not always being adequately warned about potential side effects associated with the device and has restricted sales of Essure to healthcare facilities that provide a specific brochure about the product’s risks.
The U.S. is Bayer’s biggest market for Essure. The company said in a statement that it still believes in the safety of the product and that it “benefits women by providing them with a valuable contraceptive option.”
Read the full Reuters report.