A West Virginia patient has filed a lawsuit claiming that Essure implantable birth control caused her injury. Hers is one of a number of recent lawsuits filed against Bayer over their Essure birth control.

Plaintiff Donna P. says that she had the Essure permanent birth control implanted into her body on April 10, 2008, in Charleston, W.V. She says that a doctor later confirmed that the Essure birth control implantation was successful.

Despite the success of the procedure, Donna says that she experienced severe and permanent injuries because of Essure.

Donna notes that Essure is a permanent form of birth control. She says that Essure was first made by the company Conceptus, and is now sold by Bayer, and was touted as an exciting option for women seeking permanent birth control.

While it was on the market, Essure was the only form of permanent birth control available that could be implanted non-surgically. It was created to provide an alternative to tubal ligation (having one’s tubes tied), which is a surgical procedure that requires more recovery time.

Despite the advertised benefits of Essure implantable birth control, it may have some serious side effects that can take a lasting toll on a person’s health. Donna says that she experienced pain and injury because of the device’s alleged design defects.

The Essure implantable birth control lawsuit argues that the device is not safe and effective as advertised, but in fact, the metal coils can degrade and break apart in a patient’s body, possibly perforating internal organs, causing a range of injury.

Essure implantable birth control is composed of two metal coils that are inserted into the fallopian tubes via the uterus. Sterilization is supposed to occur when the body grows tissue over the coils, preventing fertilization.

Donna says that Essure was not sufficiently tested before being released onto the market because it was approved through an “expedited” approval process. She claims the data produced by trials used to determine the safety was altered by the company to make the device appear more safe and effective in assessment than it really was.

Allegedly, Essure was only granted conditional approval for the device by the U.S. Food and Drug Administration because of concerns over how the device could affect patient health. However, Donna’s Essure implantable birth control argued that Bayer failed to properly document and notify the FDA of failures of the device, thereby violating federal regulations.

Based on this, Donna argues that Essure implantable birth control is “adulterated” and “misbranded” because its makers misrepresented it to the FDA, to medical professionals, and to consumers.

Because of the health problems associated with Essure, Bayer stopped selling the device as of Dec. 31, 2018. Despite the discontinuation of the device, the birth control may have harmed many people who had it implanted before it was pulled from the market.

This decision made headlines in the summer of last year and was reported by CNN and other news outlets. 

The Essure Implantable Birth Control Lawsuit is Case No. 2:18-cv-05365-WB, in the Court of Common Pleas, Philadelphia County.