Over 70 women have filed an Essure birth control lawsuit against Bayer, alleging that the device is defective and caused them injury.

Essure is a permanent birth control device which was designed as a non-surgical alternative to tubal ligation. The system is composed of two coils which are inserted into each of the fallopian tubes through a non-surgical office procedure, similar to IUD implantation.

Over the course of several months scar tissue is supposed to build up around the Essure coils, where it will occlude the fallopian tubes and prevent the release of eggs into the uterus. After three months, women are to receive a test to confirm that blockage has been attained.

The device for Essure was first developed in 1998 by Conceptus, a company eventually acquired by Bayer for $1.1 billion in 2013. Conceptus secured approval for the birth control device in 2002 but allegedly concealed the defects associated with Essure while it was on the market, according to some patients.

The Essure birth control lawsuit claims that Conceptus was cited numerous times by the U.S. Food and Drug Administration (FDA) for concealing important information regarding Essure and its risks. In fact, the device was only allowed to succeed, argues the Essure birth control lawsuit, because Conceptus concealed thousands of reports from patients and the FDA.

Plaintiffs claim that, had the true unsafe nature of Essure been revealed, then “the device would not have achieved acceptance in the marketplace” and the company would have failed.

Essure Complications

Patients claim there are allegedly a variety of risk factors and side effects associated with the permanent birth control device which were not warned of by the drug manufacturer. Some risks associated with the Essure device reportedly include migration of the device into other parts of the body, organ perforation, pelvic pain, abnormal bleeding, pain during sex, and more. Other issues involve the device’s coil material, which can result in fracturing, rusting, disintegration, and metal allergy reactions.

Sterilization failure is also possible with the device, reportedly resulting in women becoming pregnant unexpectedly, ectopic pregnancies or having a miscarriage.

Complications experienced by the plaintiffs in the Essure birth control lawsuit include those above. The plaintiffs say these complications often had to be resolved by removal of the device through removal of the fallopian tubes (salpingectomy), ovaries (oophorectomy), and/or uterus (hysterectomy). In some cases, these procedures resolved Essure side effects, but other complications persisted.

These side effects and complications prompted thousands of women to speak out against Essure and take legal action, such as the recent Essure birth control lawsuit. Pressure from these women prompted action by the FDA, including a detailed black box warning in 2016 and an extensive patient checklist requirement in 2018.

In July 2018, Bayer announced that it would be withdrawing Essure from the U.S. market by end of year, citing declining sales. Women involved in the Essure birth control lawsuit argue that Bayer is attempting to escape the situation without liability and aim to hold the company accountable for allegedly concealing the side effects of their device.

The Essure Birth Control Lawsuit is Case No. 2:18-cv-01438-MPK in the Court of Common Pleas of Allegheny County, Pennsylvania.