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Essure Birth-Control Device Hit With New Restrictions From US FDA

 
• By Sue Darcey

US FDA is placing more restrictions on the sale of Bayer's Essure permanent contraception device by requiring both patients and providers to read and sign off on a patient checklist highlighting adverse events.

FDA says some women still are not receiving information about the known risks of the Essure permanent contraception device before implantation, despite a boxed warning on the product and significant efforts to educate patients and doctors about the risks associated with the device.

"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. This is unacceptable," said FDA Commissioner Scott...

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