A California woman has filed a lawsuit against Bayer Healthcare Pharmaceuticals (Bayer), alleging that the Essure birth control device endangered the lives of the plaintiff and hundreds of thousands of women. She claims the corporation concealed adverse reactions, failed to conform to FDA regulations, and manufactured the Essure birth control device out of an unlicensed facility.

Plaintiff Zenaida T. says she had the Essure birth control device implanted in or close to 2016. As a result, she claims that she suffered permanent damages, including: severe pain, emotional distress, and a significant decrease in earning capacity. Zenaida claims that the adverse effects of the Essure birth control device have also caused her to undergo many surgeries, medical tests, and therapies related to her injuries.

The Essure lawsuit claims that Bayer took steps to conceal information about the production of the device from the plaintiff that would have discouraged her from having the Essure birth control device implanted. She alleges Bayer concealed the use of nonconforming, unapproved, and nonsterile material, as well as the fact that it operated out of an unlicensed facility. She says the company failed to report patients’ complaints regarding device migration into abdomens and pelvises or the perforation of uteruses, fallopian tubes, and bowels.

Essure Complications

Conditionally approved by the FDA in 2002 through an expedited review, the Essure birth control device is a form of permanent birth control for females. The device is comprised of two coils made from nickel, steel, nitinol, and PET fibers which are implanted into the patient’s fallopian tubes, where they expand and anchor. Bayer claims the coils cause tissue growth, blocking the fallopian tubes and inhibiting pregnancy. The device was marketed to patients as being a non-surgical, quick and easy form of birth control.

However, Zenaida alleges that Bayer knew about possible failures associated with the Essure birth control device, including that metals in the device may degrade and rust, causing irritation to patients, and that the degradation of PET and nitinol may be toxic to patients.

Zenaida says that on Jan. 6, 2011, the FDA cited Bayer about their failure to disclose perforations and device breakage and report non-conformity of materials. Bayer responded that, “the device may have caused or contributed to a death or serious injury, and an MDR Report is required to be submitted to FDA.”

Essure Lawsuits

The Essure lawsuit alleges that Bayer has committed a breach of warranty by providing patients with inaccurate statements about the efficacy and safety of the Essure birth control device, including false claims about pregnancy prevention, ease of device placement, and safety of materials. For these reasons, Zenaida is demanding in excess of $50,000 against each defendant for compensatory, punitive, incidental, consequential, and delay damages, as well as pain and suffering, attorney’s fees, and cost of suit.

This Essure Lawsuit is Case No. 2:18-cv-04686-WB, in the Court of Common Pleas for Philadelphia County, in the First Judicial District of Pennsylvania.