A new lawsuit has been filed in California in which multiple plaintiffs allege they suffered injuries from Essure—a method of permanent birth control.

The lawsuit was filed on July 17, 2018 and involves 84 female plaintiffs against the Bayer Co. and affiliated organizations as well as 10 unnamed defendants.

The 84 women are citizens and residents of multiple states in the U.S. including but not limited to New York, Florida, Washington, Virginia, Texas, Michigan, Ohio, and California.

The plaintiffs say they all made the decision to use Essure—the only method of permanent birth control for women which is non-surgical. The alternative to Essure is permanent birth control through tubal ligation—a surgical procedure in which the fallopian tubes are tied off preventing transport of a mature ova or sperm.

What is Essure?

Essure is permanent birth control which consists of coils designed to fit inside each of the fallopian tubes. The coils are made of nickel, titanium and polyethylene terephthalate (PET) fibers. While the insertion procedure can be conveniently done within a doctor’s office and doesn’t require anesthesia like tubal ligation, the physician must be specially trained to use a hysteroscope, light box, and monitor.

The lawsuit alleges that Bayer incentivized doctors to get the training by offering this equipment, valued at $20,000, for free if they purchased 25 units of the permanent birth control coils.

Once the Essure coil placement is in place, the inserts are expected to spur the development of scar tissue through an inflammatory reaction to the PET fibers. This scar tissue eventually builds up to completely occlude the fallopian tubes and prevent pregnancy for life.

Problems Ensue

Since Essure’s approval by the U.S. Food and Drug Administration (FDA) in 2002, there have been 26,000 adverse side effects reported to the drug and medical device oversight agency. These reports have included symptoms such as irregular menstrual bleeding, weakness, fatigue, and headaches.

In some cases, there have been complaints of joint, back, and muscle pain, hair loss. Finally, situations have been identified where the coils have migrated from their original positions and perforated organs and bowels.

The 84 female complainants in this lawsuit are bringing the following counts against the defendants:

• Negligence
• Strict Products Liability
• Breach of Express Warranty
• Breach of Implied Warranty
• Fraud

While Bayer says that it continues to support previously-made statements and advertisements about the safety of Essure, it has recently made the decision to pull the device from the market by the end of 2018.

Bayer says this withdrawal is not an admission of product defects, but that it was made with the belief that the market interest in the permanent birth control has diminished.

Nevertheless, the plaintiffs in this case and in others of its kind are seeking compensatory damages for their pain and suffering at the hands of this contraceptive device which was pushed through the approval process and remained on the market for so long. They are additionally hopeful that punitive damages will be assessed according to proof provided at trial.