German agrochemical and pharmaceutical giant Bayer AG announced today that it will pay $1.6 billion to settle the vast majority of U.S. claims brought by women who said they were sickened or harmed by the company's Essure permanent birth control, the first and only nonsurgical sterilization method.
The agreement resolves roughly 90% of the nearly 39,000 filed and pending legal claims involving alleged injuries from Essure, which is implanted in the fallopian tubes.
Bayer doesn’t admit to wrongdoing or liability in the settlement and said it continues to stand behind the “safety and efficacy” of Essure.
Women who accept the settlement will be required to drop their lawsuits or pending actions against Bayer. Other details of the deal remain confidential.
According to Bayer, women with Essure can contact their medical providers with any device-related concerns, but can also “continue to rely on the device for their reproductive health.”
More than 750,000 women worldwide have been implanted with Essure, which consist of two inch-long, flexible coils made of metal and fiber. Once inserted into the fallopian tubes, the coils gradually cause the buildup of scar tissue over a period of about three months, with the aim to eventually prevent pregnancy.
The U.S. settlement has no effect on Essure lawsuits pending in other countries, according to Bayer’s announcement.
Essure’s Troubled History
Essure was first approved by the FDA in late 2012. Between 2012 and 2018, the agency received 32,773 adverse events or other issues related to Essure through the agency’s Manufacturer and User Facility Device Experience database.
New research on Essure suggests its breakdown releases potentially toxic metals.
A recent analysis from Bayer found that women implanted with Essure reported experiencing heavier periods and more pelvic or abdominal pain than patients who were sterilized by tubal ligation.
Essure Timeline
September 2015: The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss concerns about Essure’s safety and hear the concerns of implanted women.
February 2016: The FDA announced actions intended to ensure doctors and patients are better informed about Essure’s risks, including a patient information checklist and a “black box warning” on the package insert. A black box warning is the agency’s most severe warning intended to call attention to serious or life-threatening risks.
September 2017: Bayer ceased all Essure sales outside the U.S. due to “commercial pressures,” according to The Washington Post.
April 2018: The FDA issued an order restricting the sale and distribution of Essure over concerns that women were not being adequately informed of Essure’s risks.
July 2018: Bayer announced that it would voluntarily stop selling Essure in the United States at the end of the year amid mounting lawsuits alleging Essure caused pain, abdominal pain, heavy periods, menstrual irregularities, fatigue, headaches — and even death in 15 women.
December 2018: Bayer halts U.S. sales of new Essure devices. Devices on hand may still be implanted in patients.
January 2020: Essure is no longer available in the U.S., the sole remaining country to allow implantation of the device.