Essure Side Effects Prompt FDA to Restrict Sales

The FDA issued an order restricting the sale and distribution of Essure implants, a response to reports that side effects attributed to the device pose a risk to women. The FDA action is intended to ensure that women considering the Essure device for birth control are...

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...