Bayer has announced that they will stop selling and distributing the Essure device in the United States after December 31, 2018 due to declining sales of the product. Bayer will continue to implement the restriction on sale and distribution placed by the FDA on the device in April 2018, to ensure women are fully informed of the risks associated with the device.
The FDA continues to take concerns about Essure very seriously; ensuring the safety and effectiveness of medical products is an agency priority and core part of our consumer protection role. Women considering permanent birth control should make fully informed decisions by getting information from their health care provider about the risks and benefits of all options. The FDA continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labeling and the sales restriction help to assure that women are appropriately informed of the risks. The following is an overview of some of the FDA’s efforts to monitor the safety of Essure.
FDA Restricts the Sale and Distribution of Essure
The FDA wants to ensure that each and every woman who receives Essure has been informed of the risks and benefits before getting the device implanted. The FDA has taken steps, including labeling changes in 2016 adding a boxed warning and patient decision checklist, to better inform health care providers and patients about the risks.
The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.
On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.
The FDA also approved Bayer’s new labeling that includes:
- The following statement: “The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”
- Bayer’s Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.
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