DeLauro, Schakowsky Welcome Bayer’s Decision to Halt Essure Sales
WASHINGTON, DC — Congresswomen Rosa DeLauro (CT-03) and Jan Schakowsky (IL-09) today released the following statements after Bayer announced it would halt sales of Essure—a medical device that is supposed to be a permanent form of contraception.
“Bayer’s decision to take Essure off the market is a huge win for women and their health. There have been more than 20,000 documented adverse event reports associated with Essure, and I long expressed my concern that the product’s risks were not being fully communicated to patients,” said DeLauro. “Until today, the United States was the only country in the world where you could purchase Essure—a distinction for which no one should be proud. I am glad that women in America have joined the ranks of those whose safety will no longer be threatened by this dangerous product.”
“This is a true victory for the thousands of women who raised their voices about the serious harm they suffered after using the Essure device,” said Schakowsky. “I am encouraged that this harmful device will no longer be on the market, but we need to act to prevent similar problems in the future. All women – and men – deserve to know that the medical devices on which they rely are safe. If not, they deserve access to the justice system so that they can seek recourse.”
Congresswomen DeLauro, Schakowsky, and the late Louise Slaughter, met with Food and Drug Administration (FDA) Commissioner Scott Gottlieb last December in order to discuss the safety of Essure. They also arranged a meeting between Commissioner Gottlieb and patient advocates so that their voices would be heard. Over the last year, the FDA has taken additional measures to protect women from the dangers of Essure, including restricting sales of Essure to doctors that use the FDA-approved “Patient-Doctor Discussion Checklist” so women could make a fully informed decision. In addition, Bayer announced in September of 2017 that they would remove Essure from all foreign markets across Europe, South America, as well as Canada.