The U.S. Food and Drug Administration (FDA) has announced their plans to respond to concerns about the safety and effectiveness of the permanent birth control method Essure. Until May 3, 2016, anyone can read and comment on these plans. If you have Essure, this is another chance to say your piece.
Here are the plans in a nutshell:
Add a black box warning to the Essure prescribing information that draws attention to possible risks.
Ask health care providers to go over a checklist with folks considering Essure to make sure they receive uniform information about the risks.
The FDA is also ordering the manufacturer to do a new study about Essure in the real world. The study has to compare Essure to having your tubes tied and measure how many women have pain, an accidental pregnancy, or other symptoms. A few years down the road, when the study is complete, the FDA will again consider the fate of Essure.
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