More than 30 women across the country are suing pharmaceutical giant Bayer over injuries allegedly related to its Essure permanent birth control, claiming the device led to severe Essure problems including abdominal bloating, migraines, and other abnormal side effects.

The Essure lawsuit, filed March 17 in the Circuit Court of St. Louis, on behalf on 32 women, claims Bayer knew about the health risks for years, but concealed Essure problems and risks from the plaintiffs and medical community.

One of the women, plaintiff Claudia B., a single mother from Mississippi, underwent the Essure implant where Essure coils were implanted in a non-surgical procedure at a local hospital.

Claudia states that three months after undergoing the Essure procedure, an HSG test confirmed that the Essure coils had been properly placed. Then, nearly two years after implantation of Essure, Claudia began experiencing fatigue, weight gain, abdominal bloating, migraine headaches, and pelvic and back pain – symptoms she alleges she never experienced prior to the Essure being implanted.

As a result of this pain and suffering, Claudia sought treatment with physicians for years. In September 2011, Claudia underwent an exploratory procedure and was advised that one of her Essure coils had likely migrated.  Since then, Claudia has been unable to afford a procedure to determine where that coil may be.

She is prevented from practicing and enjoying the activities of daily life she allegedly enjoyed prior to the Essure procedure and has otherwise suffered serious and permanent injuries.

What is Essure?

Essure is a small metal coil that is placed in the fallopian tubes via catheter. Essure was originally conceived by Conceptus Inc., a subsidiary of Bayer AG, as an alternative permanent birth control method for women that did not want to undergo surgical laparoscopic tubal ligation.

Essure has been issued to about 750,000 women globally, according to Bayer. Bayer purchased Conceptus in 2013 for about $1.1 billion. The US Food and Drug Administration (FDA) granted Essure approval on November 4, 2002.

Reported Essure Problems

Since entering the marketplace in 2002, thousands of women have complained to the manufacturer about serious Essure problems related to the device, and it has recently been the subject of major controversy.

Many of these women reportedly harmed by the Essure device had been filing complaints directly to Conceptus and eventually formed a support group named “Essure Problems” on Facebook. Today, the group has more than 28,000 members.

As the Essure lawsuit maintains, the Essure Problems group “demanded that the FDA take meaningful action to investigate and evaluate the building scientific knowledge concerning Essure.”

The FDA said last year that in the 13 years since approval, it had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to five fetal deaths, there were four reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.

The recently filed Essure lawsuit contends that Bayer and Essure’s original developer, Conceptus, knew about Essure’s complications and intentionally misreported and concealed facts and findings to keep the product on the market.

Last month, the FDA said it would put a pair of measures in place to address reported Essure problems, mandating a new clinical study and new guidance on using the device.

In a report issued before a September 2015 meeting of the FDA’s Obstetrics & Gynecology Devices advisory panel, the agency said it logged a nearly 1,400% spike in complaints involving Essure problems filed in the last three years.

During the hearing, Bayer’s director of global pharmacovigilance risk management, Dr. Andrea Machlitt, told the panel that the company received 17,000 adverse event reports, 15,000 from the U.S. The panel voted to recommend limited use of Essure until more is known about its safety.

A bill sponsored last year by Republican Rep. Mike Fitzpatrick of Pennsylvania would ban U.S. sales of Essure altogether.

The Essure Lawsuit is Case No. 1622-CC00690 in the Circuit Court of the City of St. Louis, State of Missouri.