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FDA Approval of the Essure System

October 15, 2015 · FLEMING | NOLEN | JEZ, L.L.P.

Bayer’s Essure System, a method of permanent female sterilization, was originally given Premarket Approval (PMA) by the Food & Drug Administration (FDA) in April of 2002. As a condition of its PMA, Bayer was required to fulfill certain obligations. However, allegations have arisen suggesting that Bayer failed to follow the conditions set out by the FDA regarding Essure. Among these continuing obligations, Bayer was required to report any adverse events concerning the Essure System to the FDA and conduct five-year follow-up studies to gather long-term safety data. When the follow-up data was finally published in April 2015, thirty percent of the participants had been lost. Dr. Aileen Gariepy, assistant professor of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine, calculated that almost ten percent of women with the Essure System will get pregnant over a ten year period. Thousands of women who claim to have been injured by the Essure device are urging the FDA to warn the public about the potential for serious complications, and to withdraw the device from the market.

The Essure device is inserted into the fallopian tubes in order to create a blockage, permanently preventing pregnancy. Some potential complications of the device are bowel perforations, device migration, and the device breaking into pieces. This can lead to pain, bleeding, and unwanted pregnancies, among other things.

Congressman Mike Fitzpatrick will introduce the “E-Free Act” on November 4, 2015, (the thirteenth anniversary of Essure’s approval) seeking the withdrawal of Essure from the market. See a copy of the bill here. Congresswoman Rosa DeLauro sent a letter to the FDA on October 9, 2015, urging that the device be pulled. See Congresswoman DeLauro’s letter here.

If you or a loved one has had an Essure device implanted and are experiencing complications, contact us or call toll free 1-(713) 621-7944 for a free consultation and case evaluation by one of our Houston product liability attorneys.