CNA Staff, Aug 23, 2020 / 15:00 pm
Pharmaceutical company Bayer has agreed on a $1.6 billion settlement payout for women who were injured by its now-discontinued sterilization device, Essure. The settlement was announced on Thursday, August 20.
Bayer stopped selling Essure in the United States in 2018, one year after it stopped selling the device in other countries. Initially, Essure was not recalled, and Bayer blamed a lack of sales, rather than safety, for why it stopped making the device. Essure was finally recalled in September 2019.
Approximately 39,000 women filed claims saying they were injured by the device, which is a metal coil that is inserted in a fallopian tube. The coil damages the fallopian tubes, and the scarring caused by the coil blocks the tubes entirely.
In thousands of cases, the coils migrated from the fallopian tubes, damaging other parts of the body. Symptoms of Essure migration include weight gain, irregular periods, fatigue, uterine perforation, dizziness, fainting, and memory lapses.
As part of the settlement, Bayer will not admit that the company was in the wrong and will not apologize to the women injured by Essure.
“There is no admission of wrongdoing or liability by Bayer in the settlement agreements,” the company said in a statement.
Bayer expects to settle 90% of the claims with the $1.6 billion payout, and the company said it is continuing to work with the remaining 10%.
The FDA added a “black box” warning to Essure in November 2016, after numerous patient complaints about complications from migrated coils.