A new Essure injuries lawsuit has recently been filed against the device’s manufacturers Bayer and French company Conceptus over adverse side effects and complications suffered by dozens of plaintiffs claiming negligence and fraud.

The new Essure injuries lawsuit adds to thousands of people across the country who have already filed similar suits. It includes 62 plaintiffs from various states and was filed at Allegheny County Common Pleas Court.

The Essure injuries lawsuit alleges the device is unsafe and causes severe adverse effects and complications including heavy/irregular menstrual bleeding; device migration out of position; perforated organs; hair and tooth loss; severe chronic pain; and auto-immune symptoms.

The 62 plaintiffs filing this suit are in addition to those in a similar lawsuit filed by 10 others in February. The February suit has since been removed from Common Pleas to the U.S. District Court for the Western District of Pennsylvania.

The Essure injuries lawsuit accuses the companies of fraudulent concealment and misrepresentation; violations under Pennsylvania’s Consumer Protection Law; failure to warn patients of product danger associated with Essure; and negligence.

Other allegations filed against Conceptus and Bayer include the company of hiding pertinent information and facts about the safety of Essure. They are also being accused of defrauding physicians as well as the public and medical community by making false claims that Essure is safer than the use of traditional tubal ligation.

According to the Essure injuries lawsuit, Conceptus and Bayer both conducted an “ongoing scheme” through their attempt of defrauding important facts and that it required “knowledge and complicity of personnel at the highest levels of Conceptus and Bayer, including the corporate officers and directors.”

According to a statement released by the company, they report that because the complaint hadn’t yet been served, they could not comment on complaint specifics. However, they did maintain that “We will vigorously defend the continued availability of Essure, which is an important option for the many women who are seeking permanent birth control. As FDA has repeatedly determined, Essure is a safe and effective medical device that benefits women by providing them with a valuable contraception option.”

The FDA limited the distribution and sale of Essure earlier this month. A black box warning was also mandated to be placed on Essure labels, in 2016, along with a patient checklist listing severe adverse side effects that must be filled out by patients and doctors acknowledging their understanding of device risks.

Essure became approved by the FDA in 2002. It is a permanent contraceptive device that becomes implanted into a woman’s fallopian tubes and features two metal coils. Once implanted, the coils expand, causing tissue in the fallopian tubes to grow thus blocking sperm from being able to enter.

In a recent news release by the FDA, they discussed their added restriction of sales of Essure. They maintained that “The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.”