The US Food and Drug Administration (FDA) Announcement
Essure: Permanent Birth Control
According to the Bloomberg news, the FDA requires Bayer to perform a study to better assess the potential risks to the users.
The FDA posted its position on the web but removed the announcement shortly afterwards. It may be due to the date as it was announced dated March 1, 2016.
The FDA stated “While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications.”
According to the news, it was recommended that Essure carry a boxed warning, a label of explaining the possible side effects. The FDA is currently working on the guidance document for the boxed warning label applicable for the sterilization devices.
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Last Updated: 2016-02-29