Ninety-four woman from 32 different states have filed a massive lawsuit against Bayer alleging they suffered serious and sometimes life-threatening adverse effects of Essure.

The Essure lawsuit, filed on December 8 in Missouri state court, claims that Bayer knowingly downplayed patients’ reports of adverse effects of Essure.

Specifically, the lawsuit claims that from May 2014 to January 2016, Bayer received more than 460 complaints about the coils breaking. But when Bayer reported these cases of adverse effects of Essure to the FDA, the company was misleading.

“Despite knowing about hundreds of instances of the Essure device breaking, Bayer has repeatedly reported to the FDA that only single cases exist. Therefore, when multiple FDA analysts read separate reports that each state ‘single cases have been reported of Essure breakage,’ it causes each individual analyst to falsely believe that instances of device breakage are extremely rare,” the 39-page complaint states.

About Essure Permanent Birth Control

Essure was approved in 2002 and remains the only non-surgical permanent birth control method on the market. It consists of two nickel alloy coils that are implanted into each of the fallopian tubes. Over time, the body builds up scar tissue around the coils, forming a natural barrier that prevents pregnancy by preventing the sperm from reaching the egg.

The devices have been linked to numerous adverse events including abdominal cramping, migraines, abnormal menstrual bleeding, infections and allergic reactions. In some cases the coils can break or migrate, and puncture the fallopian tubes or uterine wall.

Adverse Effects of Essure

According to the Food and Drug Administration, common adverse effects of Essure include mild to moderate pain, cramping, vaginal bleeding, and pelvic or back discomfort. The more serious adverse effects of Essure include:

• Unintended pregnancy, including ectopic pregnancy
• Pelvic pain
• Migration (movement) of Essure inserts through the fallopian tubes into the lower abdomen and pelvis
• Perforation (puncturing) of the uterus or fallopian tubes
• Rash and itching associated with possible nickel allergy

Additionally, if the Essure birth control implant separates, breaks or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus or fallopian tubes entirely.

Filing an Essure Lawsuit

Despite more than 5,000 complaints involving adverse effects of Essure, the FDA said it is willing to keep the device on the market but has added a black box warning.

However, this warning comes too late for many women who experienced adverse effects of Essure like organ puncture or device migration, leading to emergency surgery or other serious and permanent injuries.

If you or a loved one had the Essure birth control device implanted and suffered severe or permanent injuries as a result, you may be entitled to compensation for your pain, suffering, and medical expenses. An experienced Essure attorney can evaluate your case and advise you on your legal options at no charge.

The Essure Lawsuit is Case No. 4:16-cv-01913 in the U.S. District Court for the Eastern District of Missouri, Eastern Division.