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Members of Congress Publish Letter Expressing Concern Over FDA’s Inaction on Essure

November 8, 2017 · FLEMING | NOLEN | JEZ, L.L.P.

Three members of Congress recently sent a letter (PDF) to Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb, M.D. expressing deep concerns over the FDA’s inaction on Essure. The FDA allowed this dangerous product to remain on the market on the condition that its manufacturer, Bayer, conduct a post-market safety study a year and a half ago. However, it…
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Black Box Warning Emphasizes Dangers of Essure® Side Effects

December 19, 2016 · FLEMING | NOLEN | JEZ, L.L.P.

When the United States Food and Drug Administration issued its decision to require a black box warning on the Essure® birth control, it opened the doors to criticism against the manufacturer. It also showed that there is a danger involved with the Essure® device that people are becoming increasingly aware of, especially involving the possible side effects. These side effects…
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