A couple has lodged an Essure side effects lawsuit alleging that the manufacturers are responsible for permanent and severe injuries sustained by the wife after she was implanted with the Essure birth control system.

In 2002, Essure was given FDA approval as a permanent sterilization device for women. Many women opted to receive this device because it was marketed as effective and safe. Multiple supplemental approvals were also given relating to Essure’s manufacturing, design, warnings, and other labeling.

The purpose of the device is to block the fallopian tubes using micro-inserts. However, patients, including the plaintiffs in this Essure side effects lawsuit, report that the device can migrate from its original location and break into pieces, corrode, or perforate organs.

Plaintiffs Samantha and Randal T. claim that the manufacturer should have warned patients about the possible risks and symptoms and that the drug was misbranded and marketed inaccuarately. The Essure side effects lawsuit says that the manufacturer failed to report the known hazards, failed to comply with the federal laws about distribution marketing, and failed to meet reporting requirements.

Some of the claims against the company mentioned in the Essure side effects lawsuit include manufacturing Essure at an unlicensed facility, failing to use post-sterile cages, not reporting complaints filed by patients claiming that the product migrated, only disclosing a potion of the reported perforations out of the all the complaints filed, and not considering the volume and severity of complaints in terms of the overall risk profile for putting the drug on the market.

As alleged in the Essure side effects lawsuit, in 2013, a spreadsheet was discovered by the FDA revealing more than 16,000 complaints that were not appropriately reported to the FDA. In particular, the defendants were accused of failing to share some of the reports filed by patients when the product migrated outside of the fallopian tube.

Furthermore, the makers of Essure are accused of concealing and altering the medical records of the clinical trial participants to reflect lower levels of pain than what was really happening for patients. The causes of action in the Essure side effects lawsuit include that there were multiple federal violations of federal statutes and regulations.

When a medical device or drug is allegedly dangerous, it might take months or years for the claims filed with the FDA and the maker to be shared with the public. After numerous similar reports of injuries and pain, the FDA might conduct additional investigations to determine whether or not further warning labels must be included on the label.

Not long after Samantha and Randal filed their Essure lawsuit, Bayer announced it would finally remove Essure from the U.S. market after years of pressure from patients and patient advocates.

An Essure side effects lawsuit could be filed by anyone who already suffered serious pain and problems after the implantation of the device. Many of the lawsuits allege similar claims of migration and perforation and these all involve allegations that the maker knew about the dangers and failed to warn.

The Essure Side Effects Lawsuit is Case 2:18-cv-02679-PBT filed in the United States District Court for the Eastern District of Pennsylvania.