Bayer to Pay $1.6 Billion to Settle Defective Essure Contraceptive Device Lawsuits. The latest in an eventful year for Bayer Pharmaceuticals is a $1.6 billion settlement to resolve claims against its Essure contraceptive device. Written by Anjelica Cappellino, J.D.

When was Essure recalled?

Essure was designed as an implantable birth control device that permanently blocked the fallopian tubes in women. The manufacturer of the Essure system of birth control removed the device from the U.S. market in January 2019. Sales of the device stopped by 2017 in all other countries.

What went wrong with Essure?

Most of the reports were related to potential device removal (91%) which is consistent with the MDRs for Essure from 2017 to 2020. The most common patient problems reported were pain, perforation, foreign body/device fragments in patient, pregnancy, heavier periods (menses/hemorrhage), and hypersensitivity.

Has anyone received a settlement from the Essure lawsuit?

German multinational pharmaceutical and life sciences company, Bayer AG, has announced it will resolve 90 percent of Essure lawsuits with a $1.6 billion settlement.

Does Essure cause autoimmune disease?

Schalock and several experts in immunology or toxicology expressed concern at the 2015 FDA hearing that the nickel in Essure could be triggering allergic or autoimmune reactions, in which the immune system overreacts and attacks healthy cells.

Can Essure cause pelvic inflammatory disease?

Sedrakyan’s team did find that women who got Essure were more likely to be over 40 and to have other complications such as pelvic inflammatory disease. Bayer says the safety of Essure in women over 45 isn’t known.

Has anyone received a settlement from Essure?

In 2020, Bayer agreed to a $1.6 billion settlement in an Essure class action lawsuit. The money is meant to account for the injuries that Essure caused to thousands of women over the years.

Has anyone won an Essure lawsuit?

A New Jersey appeals court has thrown out a woman’s product liability lawsuit against Bayer (ETR:BAYN) over its Essure permanent birth control device.

What are the side effects of Essure?

Mild to moderate pain during and immediately following the Essure placement procedure. Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure. Longer-term risks to women with Essure as reported in clinical trials include:

What is the black box warning for Essure?

The black box warning includes serious side effects such as organ perforation, allergic reactions and device migration. It says additional surgery may be required to treat these Essure complications. In 2018, the FDA restricted Essure sales. Bayer only sells Essure in the U.S.

What are the risks of essessure?

Essure, the permanent form of birth control, has been linked to serious complications. The device, which consists of two metal coils inserted in each fallopian tube, may break and migrate within the body, causing chronic pain and other side effects.

What is the variance between 2016 and 2020 for Essure?

The variance is limited to events for Essure that Bayer is or becomes aware of for the period between November 2016 through November 2020. As this information is based on social media posts, these reports may reference information already reported to the FDA and do not necessarily represent new adverse events.