FDA Hits Bayer's Essure Implant with Black Box Warning
The FDA announced it will require a black box warning label for Essure, an implantable and permanent birth control device. The black box warning is the most serious available to the FDA, reserved for devices that may cause death or serious injury. More than 5,000 women have reported adverse events to the FDA which they attribute to the Essure device.
In addition to the black box warning, the FDA has ordered Bayer to conduct a study to assess the risks of the device. Further action may be taken by the FDA at the conclusion of the study. The FDA imposed various deadlines regarding the development and implementation of the study. In the event that Bayer misses any of those deadlines, the FDA reserved its right to declare the device as "misbranded."
In spite of the black box warning, many women who received the Essure devices and patient safety advocates have warned the FDA action did not go far enough.
It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.
Rep. Mike Fitzpatrick (R-PA)