“Although Essure is no longer available for implantation in the U.S., The FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study, the FDA is working with Bayer, Essure's manufacturer, to modify The FDA study to include an additional interim analysis at one year of follow up after patients' permanent birth control procedure -- this is earlier than the previously planned analysis at three years.
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- CNN 4 years ago
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