The U.S. Food and Drug Administration (FDA) announced they are restricting the sale of Bayer AG’s implanted birth control device Essure. The decision comes two years after the agency ordered Bayer to put a severe warning label on the product.
Details of the Essure Sale Restriction
According to Reuters, the FDA ruled that some women were not being adequately informed of the risks associated with Essure prior to getting implanted. The new restrictions will limit the sale of Essure to healthcare facilities that provide full information about the device’s risks and benefits.
Among the risks associated with Essure are:
Abnormal uterine bleeding
Essure was originally approved by U.S. regulators in 2002, but it received a black box warning in 2016 following thousands of complaints.
Essure Subject of more than 10,000 Lawsuits
The FDA decision could prove vital to some 10,600 lawsuits pending against Bayer in the U.S. Those lawsuits allege Bayer was aware of the risks associated with Essure, but failed to warn sellers, doctors, and regulators of the dangers.
The FDA revealed in March that is had received roughly 12,000 medical reports concerning Essure in 2017 – more than 90 percent of those reports mentioned issues around device removal.
Currently, there are an estimated 750,000 women using Essure worldwide with about 70 percent of users based in the U.S.
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