Bayer will pay about $1.6 billion and settle nearly all of the U.S. lawsuits that, over several years, have claimed the company’s Essure birth control implant caused serious injuries.
The German drugmaker’s agreements with plaintiff law firms cover about 90% of nearly 39,000 filed and unfiled claims, within all of the jurisdictions with significant numbers of Essure cases, Bayer said in a statement.
The company is also currently in talks with lawyers representing the remaining plaintiffs; the $1.6 billion figure includes an allowance for these outstanding claims. Most of the terms of the settlement agreements are confidential, but they contain no admission of wrongdoing or liability.
Bayer halted sales of the implant in 2018 after declining sales and additional restrictions from the FDA on the device, which consists of 2-inch-long metal coils placed within each fallopian tube, designed to generate scar tissue and block off the ovaries to prevent pregnancy.
Many women have claimed in lawsuits that Essure’s coils can pierce the walls of the tubes or can come loose entirely, causing pain and other serious side effects. Removal of the implant may require a hysterectomy in some cases.
“Bayer sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure,” the company said in its statement.
Previously, the FDA had ordered Bayer to conduct a postmarket safety study and added a boxed warning to Essure’s label in 2016. New patients were also required to complete a checklist fully informing them of the implant’s risks. Essure’s sales dropped about 70% over the next two years, according to the agency.
The duration of that safety study was later increased, from three years to five, alongside new FDA directives for more frequent progress reports.
Earlier this month, the FDA published the first monthly spreadsheet of publicly available social media posts detailing adverse events related to certain Essure plaintiffs, which Bayer is required to collect and catalog. It contains reports of 53 deaths, 24 device malfunctions and 1,376 serious injuries, according to the agency.
Editor's note: This story has been corrected to make clear the $1.6 billion amount covers both settled and outstanding claims.