Bayer to Stop Marketing Essure Device

Bayer has decided to stop marketing its controversial Essure permanent birth control device, effective 12/31. The company’s move follows an April FDA patient safety action, in which the agency issued an order restricting the sale and distribution of Essure (see story). “For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA,” an agency notice says. “We expect Bayer to meet its postmarket obligations concerning this device.”

FDA estimates that the device has been used by more than 750,000 patients worldwide. “The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen,” FDA says. Since it took the April action to restrict the device’s use, there has been about a 70% decline in sales in the U.S. Bayer told FDA its decision to stop marketing the device was due to commercial reasons.