STORY FROM: Drugs & Medical Devices
FDA Orders Doctors, Facilities, to Use Essure ‘Patient-Doctor Discussion Checklist’
April 9, 2018
WASHINGTON, D.C. — The Food and Drug Administration says it has restricted sales of the Essure permanent birth control device to doctors and healthcare facilities that use an FDA-approved checklist warning patients of serious side effects.
According to the April 9 announcement, the checklist provides information to patients about the risks and benefits of Essure “in the form and manner specified in the approved labeling provided by Bayer.”
The checklist is part of the patient information booklet and, according to the FDA, “has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be ...