A group of over 30 women has filed an Essure lawsuit against Bayer over complications attributed to the company’s permanent birth control system.

The plaintiffs allege that the Essure birth control system has been associated with an unacceptable number of severe complications such as breakage, migration, hemorrhaging, and pelvic pain. Some cases of Essure problems have been severe enough to require surgical removal of the device, they say.

The Essure birth control system consists of a pair of metal coil implants made of a nickel-titanium alloy. These implants are placed inside the fallopian tubes, where they stimulate the development of scar tissue. After about three months, the scar tissue blocks the tubes, preventing fertilization.

According to Bayer, about 750,000 women have received Essure implants since they were introduced in 2002.

New Allegations in Essure Lawsuit

The plaintiffs in this Essure lawsuit claim that Essure’s original creator, Conceptus Inc., developed Essure solely out of business interest. They allege that the company wanted to resolve its enormous debt by exploiting the enormous market for permanent birth control.

In the interest of gaining greater market share, Conceptus purposely understated the risks of Essure complications in its promotional materials, the plaintiffs say. They also allege that Bayer continued this promotional tactic after it purchased Essure in 2013.

Plaintiffs claim that Bayer misled the FDA about the frequency of Essure problems. They say that from May 2014 through January 2016, over 460 cases of broken Essure coils were reported to Bayer. Yet according to the plaintiffs, in a report to the FDA, Bayer stated only that “single cases have been reported of Essure breakage.”

Unsurprisingly, Bayer disputes the plaintiffs’ allegations. The company also believes the plaintiffs’ legal claims will be preempted by federal regulation covering high-risk medical devices.

This Essure lawsuit is Case No. 1622-CC00690 in the Circuit Court for the City of St. Louis, Mo.

New Requirements from the FDA

The new Essure lawsuit comes not long after the FDA issued a response to the controversy over Essure birth control. In February 2016, the FDA announced it would require a new clinical study to evaluate the risk of Essure problems like “unplanned pregnancy, pelvic pain and other symptoms,” as well as the necessity for surgical removal of the device.

The agency also plans to add new requirements for Essure’s labeling. The new labeling will include a “black box” warning designed to alert patients to the possible Essure complications that have been reported, including problems associated with the device’s insertion and removal procedures.

The agency has also proposed a patient decision checklist. The checklist is intended to be used by doctors and patients together to help ensure they both make an informed decision about Essure birth control. The checklist will include mention of the importance of getting a confirmation test three months after implantation to make sure that the implant is properly in place and that scar tissue has formed that is sufficient to prevent pregnancy.

In issuing these new requirements, the FDA stopped short of pulling Essure from the market. Despite having received over 5,000 reports of Essure complications, Essure is still valuable as the only non-surgical alternative to tubal ligation for women seeking permanent birth control.

The FDA has published draft language for the black box warning and the patient decision checklist. The agency will accept public comments on that language for a limited time.