The woman who is the proponent of new legislation called “Ariel’s Grace” has filed a lawsuit against the maker of Essure, alleging the medical device caused her personal injury.

The lawsuit also named a sales representative of Bayer, the obstetrician-gynecologist and the medical practice where the OB-GYN was employed as defendants in the case.

Plaintiff Kristiana B. filed her Essure birth control device lawsuit in federal court in North Carolina in late December after suffering the tragic death of her daughter.

Kristiana had the Essure device implanted in December 2013. The device consists of two flexible metal coils that are placed into a woman’s fallopian tubes. Following the implantation procedure, the body mounts an inflammatory response to the coils.

The inflammation in the body causes scar tissue to build around the metal coils. After a few months, enough scar tissue builds up to completely block the fallopian tubes. When the fallopian tubes are blocked, the sperm cannot reach the egg to fertilize it, thereby preventing pregnancy.

Kristiana’s Essure Birth Control Device Lawsuit

In Kristiana’s case, it was found that the Essure birth control device was not working properly, and her left fallopian tube was never fully blocked. Kristiana used backup birth control since it was determined that the Essure birth control device was not able to prevent pregnancy, but still became pregnant.

In June 2015, Kristiana suffered from severe bleeding and abdominal pain while pregnant. While still at home, her water broke and she partially delivered her child in a breach position. Her baby girl was born stillborn at an estimated 24 to 27 weeks. She named her baby Ariel Grace.

The Essure birth control device lawsuit alleges that Bayer is liable for Kristiana’s injuries. It states that following its FDA approval in November 2002, the manufacturer became aware that more than 30,000 reports of serious injuries had been filed, yet did not take any action.

According to the Essure birth control device lawsuit, the plaintiff alleges that Bayer should have and could have revised the warning label on the device as well as provided updated materials to physicians and patients that detailed the potential risks associated with the device.

Bayer “concealed and misrepresented” the possible side effects, the lawsuit states.

Kristiana’s Essure birth control device lawsuit is one of hundreds that have been filed across the country, representing thousands of women.

These lawsuits allege that the device is responsible for a number of physical problems including severe pain, excessive bleeding, allergic reaction to the metal coils, depression, triggering autoimmune illnesses, depression, unintended pregnancy, miscarriage, ectopic pregnancy, stillborn birth and more.

Because the Essure birth control device is intended to be permanent, there is not an easy and safe way to remove it in order to help women who have been injured by the device.

Many have had to undergo a total hysterectomy in order to attempt to alleviate the symptoms, but for many women, a number of  symptoms have still remained.

Bayer has previously responded to the allegations of other lawsuits by arguing it is not liable based on grounds of federal preemption law. The company stated that because the FDA approved the device as a federal agency, the company should not be held accountable for injuries caused by its use.

Before filing her Essure birth control device lawsuit, Kristiana’s situation sparked Congressman Mike Fitzpatrick to author a bill designed to abolish the preemption defense to be used by medical device manufacturers in products liability cases.

As it stands, many potential plaintiffs have been prevented from seeking legal compensation while device manufacturers have essentially had immunity from lawsuits.

The act is named “Ariel Grace’s Law” after Kristiana’s daughter. If passed, the bill will allow patients who have been injured by medical devices that were approved via the 360K Premarket Approval Process to pursue legal action against manufacturers.

Kristiana’s Essure Birth Control Device Lawsuit is Case No. 1:17-cv-00031 in the U.S. District Court for the Western Division of North Carolina.