Bayer To Stop Sales Of Essure Birth Control Implants
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WASHINGTON (CBSMiami/AP) — The maker of Essure, a permanent contraceptive implant subject to thousands of injury reports from women and repeated safety restrictions by regulators, says it will stop selling the device in the U.S.
Bayer said Friday the safety of its Essure implant has not changed and it will stop selling the device at the end of the year due to weak sales. Last year, Bayer stopped selling the device in Europe.
In April, the FDA said doctors must show women a checklist of the device's risks before implanting it.
"The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use," according to an FDA statement Friday. "For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device."
More than 16,000 U.S. women are suing Bayer over Essure.
(© Copyright 2018 CBS Broadcasting Inc. All Rights Reserved. The Associated Press contributed to this report.)