Less than 2 years after the FDA added a boxed warning to the Essure contraceptive device, the agency has imposed new restrictions on its use.
Physicians are now required to give patients a 22-page educational brochure and discuss with them the device’s risks and benefits before the device is implanted. Physicians also must inform patients of alternative contraceptive methods, answer any other questions they have about the device, and sign the brochure to document that the discussions have taken place.