FDAnews Device Daily Bulletin

French Safety Agency Sees No Need To Update Bayer Essure Labels

June 12, 2017

In contrast to the FDA, France’s National Agency for the Safety of Medicines and Health Products is not recommending label changes for Bayer’s Essure sterilization device.

Late last year, FDA required Bayer to use a boxed warning and a patient decision checklist.

An expert committee heard testimony from patient and physician groups in a public meeting and considered new preclinical data from Bayer and an epidemiological study carried out by the ANSM.

The committee concluded that available data from the scientific literature, as well as the surveillance and the results of an epidemiological study, did not negate the favorable risk-benefit assessment of the implant.

One group, the Resist Association, which represented women who testified, had requested the suspension of the device.

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