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Bayer Pharmaceuticals officials indicate the company will pay $1.6 billion to settle most of the nearly 39,000 Essure lawsuits, resolving claims alleging the birth control device caused women to suffer painful and debilitating complications due to a defective design.
Information about the Essure birth control settlement was disclosed in a press release issued on August 20, indicating that the deal is expected to resolve about 90% of the pending legislation.
The agreement includes a fund designed to address outstanding claims, and the manufacturer is continuing to negotiate resolutions for the remaining cases. The company suggested plans to settle Essure cases in its second quarter financial statement issued earlier this month, when it indicated that $1.4 billion was being set aside to resolve the litigation.
Essure was previously sold by Bayer as a permanent form of birth control, involving flexible coils inserted into the Fallopian tubes during a procedure designed to cause scar tissue to develop, which blocks the tubes and prevents insemination. However, the device was removed from the market amid thousands of reports involving painful and debilitating complications from Essure, including migration injuries, perforations, severe reactions and other problems.
Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 it was removing Essure from the US. market on December 31, 2018.
Plaintiffs who accept the settlement agreement will have to drop their pending claims, and Bayer indicates it will not admit to wrongdoing or liability. However, terms of the agreement, beyond the $1.6 billion figure, are being held confidential.
The company faced a number of approaching trial dates in the litigation, coming as a series of reports were released that highlighted the problems with Essure, including interim results from a post-marketing study the FDA released last month, which found that more than 20% of women implanted with the device faced hypersensitivity reactions, chronic abdominal pain, and abnormal bleeding, and many had much higher rates of additional gynecological procedures.
Approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures occurring in the United States.