A new Essure implant lawsuit has been filed against Bayer, alleging that the birth control device can cause significant harm to patients.

The Essure implant lawsuit alleges that Bayer misrepresented the dangers associated with the birth control device. The Essure implant lawsuit also represents many plaintiffs across multiple states and is centralized in the Allegheny County Court of Common Pleas in Pennsylvania.

Essure is a permanent birth control device that Bayer HealthCare marketed as a non-surgical alternative to tubal ligation (i.e. having your tubes tied). When the device was released, it was considered a breakthrough contraceptive device for permanent sterilization since it was non-surgical and lower risk that a tubal ligation surgery.

According to the Essure implant lawsuit, the FDA approved this permanent contraceptive system through a fast track review in 2002. Many consumers claim that the FDA approved the device too quickly and didn’t properly test the side effects, meaning patients were not properly warned of the risks.

The Essure device is composed of two flexible coils made of metal and polyester. One coil is placed in each fallopian tube in a non-surgical procedure. Over the course of a few months, scar tissue develops around the coils, blocking the ovaries from releasing eggs into the uterus. After three months, women are supposed to be evaluated by their doctors to ensure that the procedure worked, and sufficient scar tissue developed.

Despite the initial excitement after the device’s release, many consumers have reported serious complications. Essure can allegedly cause bloating, rashes, allergic reaction, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy. Since the device’s approval in 2002, over 4,500 adverse events reported have been filed with the FDA’s adverse reporting system.

“The device can migrate anywhere in the body,” the plaintiffs’ lead attorney said to WESA. The Essure implant lawsuit claims that some plaintiffs have had their implant migrate as far as their carotid arteries. The implant allegedly “can puncture some organs […] and it can cause extreme bleeding”.

The Essure implant lawsuit argues that, after implantation, some plaintiffs have suffered “almost like a permanent period.” One plaintiff, Sharon S., says she had to have a total hysterectomy, including the removal of her fallopian tubes, due to the chronic pain and bleeding allegedly caused by Essure.

In April 2018, the U.S. Food and Drug Administration placed restrictions on the sale of Essure after an investigation showed that women were not being properly informed of the risks. “Bayer should have withdrawn the device from the market in the United States, like they have in Canada and other places,” said the plaintiffs’ attorney, “yet they persist on keeping the device on the market.”

Bayer continues to deny any wrongdoing, claiming that the device is safe and effective. The company also pledges to fight for the future availability of Essure.

If you or a loved one experienced adverse side effects associated with the Essure permanent birth control device, you may be eligible for an Essure class action lawsuit investigation. An Essure lawsuit could help recover compensation for medical bills, lost wages, pain and suffering, and more.