The FDA-Approved Essure Device Counseling Order Fails to Promote Patient Empowerment

Abstract

The U.S. Food and Drug Administration (FDA) recently issued an order (U.S. Department of Health and Human Services, 2018a) that limits the sale of Bayer's (Whippany, NJ) Essure system for permanent birth control to those health facilities that provide structured information to patients on the benefits and risks of the hysteroscopically implanted metal coils, as higher rates of unintended pregnancy have been identified in real-world conditions compared to initial trial outcomes (Hurskainen et al., 2010). In early 2016, a black box warning (U.S. Department of Health and Human Services, 2016) was issued for the device and Bayer was ordered to conduct a postmarket surveillance study to gather additional data about the benefits and risks of Essure. This most recent order takes the black box warning a step further: issuing a document entitled “Patient-Doctor Discussion Checklist. Acceptance of Risk and Informed Decision Acknowledgement” (Bayer Healthcare, 2018). Physicians are required to provide and review this document with patients considering Essure and obtain a patient signature indicating consent. The checklist is accompanied by a 16-page patient brochure, one-half of which is devoted to safety information for the product.

Keywords

• patient empowerment
• birth control
• Essure
• readability