FDA Restricts Sale, Distribution Of Essure; Requires Patients And Doctors To Review Brochure

FDA announced Monday (April 9) it is restricting the sale and distribution of Essure, a permanent contraceptive device, by limiting the device to prescription use and requiring labeling that specifies the training or experience practitioners must have to prescribe and implant the product. Additionally, patients and doctors are now required to review an informative brochure about the risks and benefits associated with the device, as FDA maintains that patients have not been properly informed about the product. The move comes...