The Food and Drug Administration said Monday that it is restricting the sale and distribution of Essure, a controversial contraceptive device that some patient advocates want taken off the market. Only health-care providers and facilities that guarantee women have been told about the device’s risks in advance will be allowed to implant it.
Using what it called “a unique type of restriction,” the FDA said providers must first review a brochure with patients that lists Essure’s risks. The patient then must be given the opportunity to sign the document, and the physician implanting the device will be required to sign it.
