07/21/2018
The FDA said today that Bayer will no longer sell or distribute its Essure permanent birth control device in the US, effective December 31.
FDA Commissioner Scott Gottlieb said the action 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 release.
“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,” Gottlieb said in a prepared statement.