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The FDA (Food and Drug Administration) said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device.  A black box warning in the labeling of products is designed to call attention to serious or life threatening risks according to the FDA website.  http://www.fda.gov

Over 5000 women have filed grievances with the FDA between 2002 and 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.

The FDA also called upon Bayer, which makes and markets Essure, to conduct surveillance that will assess “risks of the device in a real-world environment,” and said the agency will use the results of that study to “determine what, if any, further actions related to Essure are needed to protect public health”.  The company is required to follow more than 2000 women for at least 3 years.  Essure is a permanent form of birth control in which a coil is non-surgically placed into a woman’s fallopian tubes.  Scar tissue is supposed to form around the device to prevent sperm from reaching eggs and fertilizing them, thus preventing pregnancy.

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