The FDA was notified on July 20, 2018 that Essure permanent birth control would no longer be sold or distributed in the US after December 31, 2018. This notification followed earlier actions on the part of the FDA related to this device. As of December 31, 2019, there should no longer be any unused Essure units on the market – i.e., they should have all been returned to Bayer.
Patients Currently Using Essure
The FDA statement (January 2020) includes additional information (see ‘Primary Sources – Learn More’ below) that addresses the ending of the sale and distribution of Essure and states the following
Women who have been using Essure successfully to prevent pregnancy can and should continue to do so.
The FDA remains committed to collecting long-term safety information in women who have received the device. This includes ensuring that Bayer continues to meet its mandated postmarket study obligations for Essure beyond 2019. We believe clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. We will continue to provide updates on our ongoing postmarket evaluation of Essure to the public as new information becomes available.
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Media - Internet
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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