Essure is a permanent birth control device manufactured by Bayer Health care. The device consists of two small nickel alloy coils, which are implanted through the vagina into the fallopian tubes. Scar tissue forms around the coils, preventing sperm from reaching the eggs. Since its approval in 2002, 750,000 Essure devices have been implanted. Adverse events reported with Essure include migration, leading to perforation of the fallopian tube or uterine wall or embedment in other organs, often requiring hysterectomy or surgical removal; allergic reactions; severe pain; and infection.
The device 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. In 2015, The journal BMJ published research showing that women who received the 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 its decision was based on declining sales and not on the controversy surrounding the device.
In August 2020, Bayer announced a $1.6 billion settlement to address claims of adverse effects associated with the device.