Several women have joined in a new Essure lawsuit seeking to hold manufacturer Bayer responsible for complications associated with the birth control implants.

The group of twenty plaintiffs comes from several different states all over the U.S. They claim that Bayer and its associated companies failed to issue adequate warnings about the “serious health risks” associated with Essure, an implantable device used for permanent birth control.

Plaintiffs say that after Essure entered the market, about 16,000 complaints were lodged alleging serious Essure side effects. Once these reports began to surface, the plaintiffs say, Bayer should have reported these complications to the FDA.

They also say Bayer should have put healthcare providers on notice of the problems by revising the warning label for the device.

In the face of these reports of Essure complications, the plaintiffs say, Bayer nevertheless advertised Essure as being both safer and more effective than other methods of permanent birth control – advertisement the plaintiffs say was false.

The plaintiffs claim that they and their doctors relied on these allegedly false advertisements when they chose to receive Essure implants.

According to the plaintiffs, Essure consists of two small implants that are inserted into the fallopian tubes and anchor in place. The implants are made of two metal coils, one of a nickel-titanium alloy and the other of steel covered in polyethylene terephthalate fibers.

Once in place, these implants stimulate the growth of fibrous tissue that ultimately blocks the fallopian tubes, preventing fertilization. The Essure implants were designed to be permanent, the plaintiffs say.

Essure Lawsuit Recounts Plaintiffs’ Experiences

The Essure lawsuit contains descriptions of the purported Essure complications each plaintiff suffered.

One plaintiff, Beth A., says she chose to receive Essure implants as an alternative to the more traditional tubal ligation surgery. In the following years, Beth says she suffered from increasing pain and irregularity of menstruation.

To resolve her Essure side effects, she says she had to undergo a hysterectomy with bilateral salpingectomy in May 2014.

Another plaintiff, Cynthia B., says she also experienced abdominal pain and heavier, longer menstrual cycles after receiving a pair of Essure implants. A doctor’s examination confirmed that her implants had migrated out of her fallopian tubes, she claims.

She also had to undergo a hysterectomy to resolve her Essure complications.

A third plaintiff, Shaunta D., said that her Essure side effects included debilitating migraine headaches and excessive bleeding. Her menstrual bleeding became so heavy that she became anemic, she says. Shaunta claims her health care provider attempted to implant a Mirena IUD to try to get the bleeding under control, but the bleeding and pain continued.

The plaintiffs in the Essure lawsuit generally allege that they relied on representations in the promotional materials for Essure that described the device as a safe and effective alternative to tubal ligation. Many of them say they originally planned to undergo a tubal ligation but were persuaded to try Essure based on these representations.

The women’s Essure lawsuit raises claims for negligent failure to warn, strict products liability for inadequate warnings, negligence, breach of warranty, negligent misrepresentation, and fraudulent concealment.

The Essure Lawsuit is Case No. RG16816162 in the Superior Court of the State of California, County of Alameda.