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New restrictions on Assure sterilization device in the United States


The U.S. Food and Drug Administration (FDA) imposed new restrictions on the permanent contraceptive implant following reports of painful complications from thousands of women.

Nevertheless, the metal implant made by Bayer is still on the market. FDA 

From now on, only women who read and sign a leaflet about the risks associated with the device can be prescribed Essure. The woman's doctor must also sign a checklist of risks. These new regulations take effect almost two years after stern warnings from the FDA who ordered Bayer to carry out a study on the device’s safety. An agency spokesperson confirmed that, taking these new requirements into account, the device continues "to meet our standards for a reasonable assurance of safety and effectiveness".
Fonte : genethique



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