Bayer to Halt Sales of Essure
Bayer announced on Friday that it would halt the sales of the controversial birth control device Essure by the end of the year.
The decision today to halt Essure sales also follows a series of earlier actions that the federal Food and Drug Administration took to address the reports of serious adverse events associated with Essure’s use.
According to the New York Times, there have been reports of anywhere from 27,000 to 30,000 reports of adverse events. Essure consists of a steel coil inserted through the vagina and into the fallopian tubes.
“With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer simply didn’t jibe with the data that was pouring into the FDA. from both patients and physicians,” Madris Tomes, former FDA medical device official, told The New York Times.
In a statement, the FDA said, “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.”