Pharmaceutical giant Bayer AG has agreed to pay $1.6 billion to settle thousands of lawsuits from women who alleged Bayer’s Essure permanent birth control device was defective and injured women, Law360 reported. The deal resolves about 90% of the near-39,000 lawsuits filed by women in the U.S. It includes about 27,000 lawsuits consolidated in California and more than 10,000 others pending in federal court in Pennsylvania as well as other courts across the country.
Bayer said Monday that it was making “good progress” in resolving the litigation, having set aside $1.5 billion for a settlement. News of the final plan came early Thursday afternoon.
Essure was developed by Conceptus Inc., and approved by the Food and Drug Administration (FDA) in 2012. It was an exciting launch, as Essure was the only nonsurgical permanent birth control device on the market. Its approval hinged on Conceptus conducting two studies after the device was released – one to gather five-year follow-up data to assess the safety and the other to gauge the placement of the implants in each of the fallopian tubes by newly trained physicians. In 2013, Bayer acquired Conceptus and its contraceptive.
The device consists of two coils that are inserted into the fallopian tubes. Over weeks, scar tissue builds up around the device, blocking the sperm from reaching the egg and fertilizing it.
Since its approval, Essure has been plagued with adverse event reports including pain, perforation of the uterus or fallopian tubes, hypersensitivity reactions, unintended pregnancy, and device migration to other parts of the body.
In 2015, The journal BMJ published research showing that women who received the Essure implant were 10 times more likely to need repeat surgeries compared to women who had a tubal ligation.
On July 20, 2018, Bayer announced that as of Dec. 31, 2018, it would no longer sell or distribute any more Essure devices in the United States. The company said is decision was based on declining sales and not on the controversy surrounding the device.