Dozens of plaintiffs have joined in a single Essure lawsuit, claiming that Essure leads to unintentional pregnancies and other complications.

The plaintiffs include over two dozen women who say they were implanted with the Essure birth control system.

They each allege they suffered painful and harmful complications following implantation of Essure.

The plaintiffs report suffering a wide spectrum of complications after receiving Essure implants.

Among these are abdominal pain, headaches, fatigue, and abnormal menstrual bleeding.

Some report hair loss, back pain, pain during intercourse, and a metallic taste in their mouths. Others report gastrointestinal troubles like irritable bowel syndrome.

A few report their Essure implants moved out of their position in the fallopian tubes and migrated elsewhere in their body.

In some cases the implants could not be recovered. Several plaintiffs allege they had to undergo a hysterectomy to get relief from their complications.

The Essure Birth Control System

Essure is a method of permanent birth control developed to be an alternative to surgical sterilization via tubal ligation.

It consists of a pair of implants, one for each fallopian tube. The implants are inserted into the tubes and left in place. They then stimulate growth of new tissue that after a few months blocks the fallopian tubes, preventing fertilization.

Plaintiffs allege that when the FDA approved Essure for sale in the U.S., it was not aware that Essure leads to unintended pregnancies, chronic pain, prolonged bleeding, and perforation of the uterus.

They allege that Bayer neglected to inform the public about nearly 16,000 complaints of serious injuries suffered by women who were implanted with Essure.

Plaintiffs also claim Bayer failed to report this information to the FDA on a timely basis.

Reports like these eventually led the FDA to require a black box warning to the label for Essure, the plaintiffs say.

In February 2016, the FDA added the new warning to advise patients and doctors of reports of “perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions.”

At the same time, the FDA also ordered Bayer to conduct a new postmarket surveillance study and issued a “patient decision checklist” to help ensure patients are fully informed about the associated risks before choosing to undergo Essure implantation.

The plaintiffs claims that despite knowing about these reports, Bayer “falsely advertised, warranted and represented that Essure was safer and more effective than other methods of permanent birth control.”

Plaintiffs: Essure Leads to Unintentional Pregnancies

Plaintiffs dispute promotional statements that say Essure is the “[o]nly FDA approved female sterilization procedure to have zero pregnancies in clinical trials.” Much to the contrary, they cite evidence that suggests Essure leads to unintentional pregnancies.

Plaintiffs claim that four pregnancies were reported during clinical trials, and five others were reported during Essure’s first year of clinical use. Between 1997 and 2005, Bayer received reports of a total of 64 pregnancies, the plaintiffs claim.

They also cite a study that concluded Essure leads to unintentional pregnancies ten times more often than laparoscopic sterilization, with that risk increasing fourfold after ten years.

The Essure Lawsuit is Case No. 2:16-cv-06822, in the U.S. District Court for the Central District of California.