Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance
Without doubt, pairing identifiers to devices and clinical data to derive meaningful insights into a device's true efficacy and risk is an important step for the field, but the Essure debate must also give clinicians pause to reflect on the other factors influencing Essure's reputation. The Essure journey from Conceptus to Bayer demonstrates the power that social media and potential deep-pocket litigation can have on patient and clinician perception.
In addition to highlighting potential improvements to the U.S. Food and Drug Administration’s system of device approval, let us also reflect on the boom and bust phenomenon of contraceptive development throughout history. The authors admit that, “In the case of Essure, safety concerns have been driven by publicly generated reports spurred by intense media attention.1” Also, the authors remind us that “The American College of Obstetricians and Gynecologists justifiably argues that Essure offers a less invasive and potentially safer permanent contraception solution for many women who are poor surgical candidates.2” Let us not abandon this less-invasive and potentially safer option prematurely under pressure of the clear driving force of negative media in the absence of rigorous scientific evidence.