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Bayer Halts Essure Sales In EU As US FDA Relies On Study, Patient Warnings

 
• By Sue Darcey

Bayer AG said Sept. 18 it will not renew a CE mark for its Essure permanent contraceptive coils for women in EU countries, effectively halting sales of the product outside the US. The firm says its decision was "unrelated to product safety or efficacy," and driven by its commercial strategy. Meanwhile, US FDA calls for warnings and black box labels for Essure in the US, and says a Sec. 522 post-market study it ordered Bayer to complete "will help us better understand" thousands of complaints about the device.

Bayer AG will not attempt to renew its CE mark for the Essure permanent birth control method, ending the product's use in EU and other countries outside the US, the firm said Sept. 18. Bayer says there is "not much patient interest" in Essure in Europe.

Meanwhile, US FDA still supports uses of the product by American women, albeit with a black-box on the label with...

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