The FDA was notified on July 20, 2018 that Essure permanent birth control will no longer be sold or distributed in the US after December 31, 2018. This notification follows earlier actions on the part of the FDA related to this device.
In 2017, the FDA provided guidance, a ‘black boxed warning’ and a patient decision checklist to ensure all women were aware of potential risks associated with Essure. On April 9, 2018, the FDA concluded that some women were not being adequately informed. Therefore the FDA initiated a unique type of restriction that limited the sale and distribution of Essure, with the imposition of additional requirements.
The FDA statement that addresses this notification on the ending of the sale and distribution of Essure includes the following information
Women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take. Device removal has its own risks. Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them.
For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.
Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed
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