Bayer, FDA extend Essure postmarket safety study by 2 years

The FDA and Bayer are revising and extending a postmarket safety study of the Essure permanent birth control implant, following earlier regulatory actions restricting its use and the company’s decision to pull it from the market.

Bayer previously announced in July that Essure would not be sold in the U.S. after the end of this year, citing declines in sales.

In April, the FDA had restricted the device’s sale and distribution to providers that gave patients information on the risks and benefits of the device—following the additions of a boxed warning and patient decision checklist requirement in 2016, as well as an order to complete a postmarket study. At that time, Bayer estimated that Essure sales had dropped about 70% in two years.

Now, the agency is extending the duration of the real-world study from three years to five, and is calling for additional blood testing to track signs of immune responses to the implant.

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“This significant extension follows the FDA’s request that the company go beyond the three-year period provided for by law,” FDA Commissioner Scott Gottlieb said in an agency statement. “This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.”

The FDA is also requiring Bayer to submit more frequent reports on the study’s progress and results, and to continue enrolling patients that may receive the device before its discontinuation from the U.S. market.

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However, with the decline in sales and the move to pull Essure from the market, Bayer is having trouble meeting the study’s enrollment goals.

“Bayer has worked cooperatively with the FDA throughout the implementation of the study and on these study amendments, which provide a measure of flexibility for patient enrollment and allow us to collect additional and valuable long-term data," said Edio Zampaglione, M.D., Bayer’s vice president of U.S. medical affairs, women's healthcare and neurology.

In his statement, Gottlieb said that women who have been using Essure to prevent pregnancy successfully and without pain or other symptoms should continue to do so, and that removing the device carries its own risks.