Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance

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The article by Walter et al1 intended to use Essure as an illustration of potential flaws within the U.S. Food and Drug Administration's system of device approval. The tone of the article insinuates that Essure was given approval prematurely, with new risks now coming to visibility. More than once, the article refers to the sharp rise in adverse events reported in 2013, with “driving forces” remaining unclear. It must not be ignored that the sharp rise in adverse events related to Essure corresponds exactly with the purchase of Essure by Bayer from Conceptus.
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.
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