The FDA will restrict sales of Bayer’s Essure birth control device. This new safety measure is being enforced because the agency discovered that some women were getting the birth control device implanted, but weren’t adequately informed about the risks.
“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 said in a statement.
“Despite previous efforts to alert women to the potential complications of Essure,” he continued, “we know that some patients still aren’t receiving this important information. That is simply unacceptable.”
Because of this, the sale and distribution of Essure will now be limited to healthcare professionals who agree to review and discuss the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.”
This checklist will be used to verse patients and doctors on the risks and benefits of the birth control device. Patients will be required to sign the decision checklist before they move forward with the procedure.