In July 2018, Bayer, which manufactures the Essure device that is intended to prevent pregnancy, announced that Essure will no longer be sold or distributed in the United States after December 31, 2018, citing the declining annual number of implantations. Even though Essure is no longer sold, the FDA announced in December 2018 that it would remain vigilant in its oversight of the Essure device, including requiring that Bayer complete the postmarket surveillance study that the FDA ordered in February 2016.
As part of the revised protocol for the postmarket surveillance study, the FDA is requiring Bayer to implement several approved modifications to the study to strengthen the evidence collected:
– Women in the study will be followed for five years, rather than the three-year period provided for by law, which will provide the FDA with longer-term information on adverse risks of the Essure device, including issues that may lead women to have the device removed;
– Additional blood testing of patients enrolled in follow-up visits during the study are required to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation, to better evaluate potential immune reactions to the Essure device and whether these findings are associated with symptoms that patients have reported related to the device;
– Bayer is required to continue to enroll patients who might still opt to receive Essure device in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results.
Since the FDA’s 2016 decision to order Bayer to conduct the postmarket study and then to add a boxed warning and Patient Decision Checklist to the labeling, sales of the Essure device declined by 70%. In early 2018, the FDA decided to restrict the sale and distribution of Essure to only health care providers and facilities that provide information to patients about the risks and benefits of Essure and that give patients the opportunity to sign an acknowledgement of understanding before implantation.
In announcing the FDA’s new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales, the FDA Commissioner stated, “We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them. The FDA will continue to collect and review reports of adverse events associated with device removal and is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.”
If you or a loved one had the Essure device implanted and suffered unexpected pain, bleeding, perforation of the uterus or fallopian tubes, or other complications, you should promptly seek the advice of a medical device claim lawyer in your U.S. state who may investigate your Essure claim for you and represent you in an Essure claim, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find Essure lawyers who may assist you.
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