A young Kentucky woman has filed an Essure complications lawsuit claiming that Bayer’s contraceptive product was to blame for her hysterectomy.

Plaintiff Mary L., from Kentucky, was implanted with the Essure medical device to prevent pregnancy on July 10, 2010. According to her Essure complications lawsuit, she chose Essure because her doctor assured her this was a good way to avoid surgery while making sure that her pregnancy prevention would be permanent.

Essure is the only non-surgical, female sterilization option available on the market currently. The Essure device, manufactured by Bayer, is made up of two small metal coils.

Through a non-surgical method, the coils are inserted in each fallopian tube. These small coils essentially create a blockage in the fallopian tubes preventing the sperm and egg to meet. When the tubes are placed, scar and other tissue forms around each tube causing a bilateral occlusion, or blockage.

When Mary was implanted with the Essure coils, she believed that this would be a healthier way to permanently prevent pregnancy than going through tubal ligation. However, she began to experience severe side effects that she believes are from the Essure device, the Essure complications lawsuit states.

According to her Essure complications lawsuit, Mary began to suffer weakness, dizziness, lightheadedness, vaginal pain, vaginal bleeding and excessive menses.

Because of these symptoms, in February 2017, Mary underwent a complete hysterectomy. This surgery, she believes, was as a result of her failed Essure devices. Despite having chosen Essure as a way to avoid surgery, she ended up having to go through an even more extensive surgery.

Mary claims that instead of providing a safe, non-surgical form of permanent birth control, Essure “migrates from the tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body.”

Other possible Essure complications listed in this Essure complications lawsuit include:

• The stainless steel can rust and degrade,
• The body can attack the nickel in the device,
• There can be trace lead in the device,
• The Galvanic action that is used to ensure the device stays within the fallopian tubes can be an irritant,
• The nitinol in the device can degrade, increasing toxicity, and
• Latent manufacturing defects can cause nickel to leak into the body of the patient.

Her Essure complications lawsuit goes into great detail describing how Essure is not only unsafe, but also that the medical device makers knew about problems and violated the law during the approval process.

It claims that the U.S. Food and Drug Administration found that Bayer kept secret thousands of incidents of perforation, logged on an internal spreadsheet. The FDA uncovered, according to this Essure complications lawsuit, at spreadsheet that logged over 16,000 entries of Essure complaints that were not correctly reported to the FDA.

Bayer claims that they did not report the incidents of perforation and migration because those women were “not -at last contact- experiencing pain …. and were mere trivial damage that does not rise to the level of a serious injury.”

Additionally, this Essure plaintiff claims that Bayer both concealed and changed the medical record of its clinical trials so that the data would reflect favorably on the Essure medical device. They are accused of changing the ages of patients as well as altering reports of pain levels.

Mary’s Essure Complications Lawsuit is Case No. 4:17-cv-02351 in the United States District Court for the Southern District of Texas, Houston Division.