WASHINGTON — The maker of 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.
WASHINGTON — The maker of 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.
The Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.
In May, the FDA said doctors must show women a checklist of the device’s risks before implanting it.
More than 16,000 U.S. women are suing Bayer over Essure.
