Essure Permanent Birth Control: New Boxed Warning, Removal Poses Significant Risks
December 9, 2016 | Strategic Insights for Ambulatory Care
The U.S. Food and Drug Administration (FDA) is requiring the addition of a boxed warning and a patient decision checklist to labeling for the Essure permanent birth control device, according to a November 15, 2016, FDA press release. The patient decision checklist provides critical information about the device, its use, and safety considerations. It can be used to facilitate discussions with providers about the risks and benefits of using the device.