Today FDA announced an order to restrict the sale and distribution of the permanent contraception device Essure. The action is to ensure that all women who are considering using the device are given risk information in order to make informed decisions.
“FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.” – FDA
According to an FDA news release, since the agency required that Bayer conduct a postmarket study, followed by a boxed labeling warning and patient decision checklist, the U.S. sales of Essure declined about 70%.
“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,” said FDA Commissioner Scott Gottlieb, M.D., adding that he met with women to listen to their concerns about the device. “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
The new labeling is legally required when Essure is offered to a patient, and the sale and distribution of the product is restricted only to healthcare providers and facilities that give patients information about the risks and benefits of the device.
The agency states that it will enforce these requirements and will take action for a failure to comply, which includes criminal and civil penalties, if applicable.