According to patient claims, Essure permanent birth control may cause adverse side effects after implantation.

Plaintiff Melissa G. has filed a lawsuit against Bayer Corporation, Bayer U.S. LLC, Bayer Healthcare LLC, Bayer Essure Inc., and Bayer Healthcare Pharmaceuticals Inc., claiming that the permanent birth control device that the companies produce, Essure, caused her physical injury.

Melissa claims that the companies knew or should have known that the device could cause injury, but marketed and sold it nonetheless. She says that the companies misrepresented Essure as safe and effective. She says that had she known the device could cause her pain and injury, she would not have chosen Essure as her form of birth control.

Essure was approved by the U.S. Food and Drug Administration in 2002. When it was approved, it was seen as an exciting option for women seeking permanent birth control. Before Essure was released onto the market, the only form of permanent birth control available was tubal ligation, more commonly known as getting one’s “tubes tied.”

Essure permanent birth control was allegedly marketed as a less invasive alternative to tubal ligation, because it did not require surgery, general anesthesia, or time off of work for recovery, as was the case with tubal ligation.

Melissa notes that Essure is implanted in a short outpatient procedure. In the procedure, a doctor inserts two metal coils through a patient’s uterus and into her Fallopian tubes. The body then grows tissue over the coils, which prevents a patient from becoming pregnant. The procedure can reportedly take three months to take effect.

Melissa claims that the procedure was not the effective and safe form of permanent birth control advertised by Bayer. Allegedly, the metal coils can migrate from the tubes, perforate organs, break into pieces inside a patient’s body, and/or corrode after implantation. All of these possibilities are not advertised, critics claim, and should be considered defects of the device.

The Essure permanent birth control class action lawsuit argues that these occurrences end up “wreaking havoc on the female body,” and can cause permanent injury and damage.

Melissa argues that when Bayer acquired Essure from its developers, a company called Conceptus, the device did not go through sufficiently rigorous testing before being released onto the market.

Allegedly, the approval process for Essure was expedited, and information that indicated that the device could be dangerous was altered. The records of people involved in pre-market testing of the device were “altered to reflect favorable data,” the lawsuit claims.

Allegedly, even after this data was misrepresented, Bayer only received approval of the device that was based on their continued monitoring of the device’s efficacy, so the company should have known that it could be dangerous and that the FDA had reservations about its safety.

Melissa states that the companies misrepresented the device as safe and effective despite the FDA’s reservations, and actively concealed evidence that the device was dangerous in an effort to increase the sales of the device.

The Essure Permanent Birth Control Class Action Lawsuit is Case No. 2:18-cv-05372-CFK, in the U.S. District Court for the Eastern District of Pennsylvania.