Congress Calls for Withdrawal of Approval for Bayer’s Essure Birth Control Device
Since the Essure sterilization device was approved in 2002 by the U.S. Food and Drug Administration (FDA), over 5,000 reports have been made about injuries stemming from the use of the device. In a recent NPR report, a representative from the National Center for Health Research indicated that Bayer, the manufacturer of Essure, may not have provided the FDA with all the information it had regarding the device’s potential complications at the time Bayer sought approval of the device. Some of this research indicates that the device may fail up to 10 percent of the time.
The pressure to address Essure’s complications heightened earlier this month when Congress drafted a bill calling for the FDA to remove the device from the market within 60 days after numerous women testified at a Congressional hearing about how the device had negatively affected them.
Recently, the FDA’s Obstetrics and Gynecology panel convened to discuss the device and how patients can best assure their safe use of the product. The device is particularly popular due to its status as the only non-surgical and permanent birth control method that the FDA has approved.