A group of patients and their spouses have filed a massive lawsuit against the Bayer Corporation for injuries sustained from Essure side effects.

One plaintiff, Donara S. of Florida, thought Essure was the perfect choice for her. With a promise of Essure being a permanent solution with no down time, Donara was sold.

At that time, she never would have thought she would be a plaintiff in an Essure lawsuit.

What Is Essure Permanent Birth Control?

Essure Permanent Birth Control System isn’t very complicated. Two small metal and fiber coils are inserted into the fallopian tubes, which are reached through the vagina.

Over the course of three months, scar tissue grows around the inserts and blocks the fallopian tubes to block the eggs’ release.

Essure Complications Start Quickly

More than 750,000 women have been implanted with Essure, and thousands have suffered Essure side effects that have adversely affected their lives and the lives of their families.

Donara underwent the Essure procedure in November 2011 at a clinic in Pembroke Pines, Florida.  Soon after implantation, she began to suffer Essure side effects such as severe menstrual, abdominal and back pain. She also endured heavy bleeding, painful intercourse and fluctuating weight.

Donara began feeling fatigued and depressed. Her pain became so intense that she was hospitalized and prescribed the narcotic painkiller Percocet.

In early October 2014, Donara had a hysterectomy in order to remove the Essure device. The doctor who performed that surgery told her that her injuries were most likely caused by Essure side effects.

Essure Complications from Nickel Allergy

Essure birth control coils consist of a blend of nickel and stainless steel, materials often used in stents and other medical implants. The Centers for Disease Control and Prevention estimates that between 10 and 20% of the population is allergic to nickel. Donara is allergic to nickel.

When the FDA approved Essure permanent birth control for the public in 2002, the regulating agency surprisingly did not insist on a black box warning of Essure’s nickel content until 2011.

Symptoms of an allergic reaction after implantation can include itching, rashes, and in some cases, painful inflammation throughout the body. Some of Essure side effects are attributed to nickel allergy.

Essure Lawsuit Says FDA Was Ignored

In November 2002, the FDA granted Essure Conditional Premarket Approval, which meant Essure had to follow certain guidelines during that period of time.

According to the complaint, Essure failed to comply with the FDA rules. Essure did not follow up with women in original clinical trials; did not conduct post-approval studies; did not report complaints of adverse events to the FDA; and failed to notify the FDA of internal records of more than 16,000 complaints regarding Essure.

What Essure DID do was launch a misleading and false advertising and marketing campaign that misrepresented the results of clinical trials, say the plaintiffs.

The Essure Lawsuit is Case No. 2:16-cv-02717-JHS in the U.S. District Court for the Eastern District of Pennsylvania.