A Texas plaintiff and dozens of others have brought a lawsuit against Bayer Healthcare, alleging that the company’s Essure birth control caused serious Essure birth control side effects.

According to the complaint, plaintiffs, the public, and the medical community were not adequately warned about the potentially severe Essure birth control side effects linked with the device.

The lawsuit alleges that Bayer violated the Conditional Premarket Approval (CPMA) from the U.S. Food and Drug Administration.

These violations are not only allegations in the lawsuit, but are also noted in FDA documentation. The FDA cited Bayer Healthcare for “failing to report and actively concealing 8 perforations which occurred as a result of Essure.”

The company was also noted to have manufactured Essure without a license for three years, manufactured Essure in an unlicensed facility, failed to report complaints of Essure migration and breakage, as well as several other issues.

According to the lawsuit, the FDA also discovered on May 30, 2013, a spreadsheet listing 16,047 entries of Essure-related complaints that were not reported properly to the FDA.

The lawsuit alleges that, because of these unreported Essure birth control side effects and violations of the FDA CPMA, the product should never have even been sold to the plaintiffs.

Plaintiffs allege that, had they been informed that Bayer had actively concealed Essure birth control side effects and committed these other violations, they would never have been implanted with an Essure birth control device.

The lead plaintiff in the lawsuit, Jennifer S., is a resident of Texas. The dozens of plaintiffs involved in the lawsuit come from states all over the country, including California, Georgia, Kentucky, and Wisconsin, and several others.

Essure Background

Essure birth control coils are a popular method of permanent birth control. Essure was first released onto the market by Bayer Healtchare after its FDA approval in 1998.

The Essure device consists of two metal coils which are implanted individually into each of the woman’s fallopian tubes. After initial implantation, it takes several months for the coils to effectively prevent pregnancy.

This is because the tissue surrounding the coils takes time to grow, eventually blocking access to the fallopian tubes completely.

Essure Birth Control Side Effects

Some Essure birth control side effects that have been reported and cited in lawsuits include abdominal pain, depression, ectopic pregnancy, pregnancy, fatigue, heavy bleeding, pain during intercourse, severe back pain, migraines, and weight fluctuation.

The most often reported Essure birth control side effects are filter migration and organ perforation. In some cases, Essure device have migrated from its original placement and traveled to perforate organs, which can be very dangerous.

Essure Birth Control Lawsuits

Unfortunately, thousands of women who have had this device implanted have later filed adverse event reports or even lawsuits over Essure birth control side effects.

These lawsuits allege that the company either knew or should have known about the serious risks linked with the device, including perforation, ectopic pregnancy, heavy bleeding, and pain.

If you or someone you love has suffered from any of these Essure birth control side effects or others after being implanted with the Essure birth control device, you may be able to file an Essure lawsuit.

The Essure Birth Control Side Effects Lawsuit is Case No. 2:16-cv-01921-JLS, in the U.S. District Court for the Eastern District of Pennsylvania.