“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA commissioner Scott Gottlieb, MD, said in the press release, adding that it is unacceptable that some women were not being adequately informed.
“Every single woman receiving this device should fully understand the associated risks,” he said.
Terri Cornelison, MD, assistant director for the health of women in the Center for Devices and Radiological Health added that ensuring informed decision making is just one important step in ongoing efforts to monitor the Essure device.
“We remain committed to carefully and throughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” she said. “While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings and consider regulatory options that appropriately balance benefits and risks for Essure.”