A new Essure birth control lawsuit was recently filed in Pennsylvania federal court against Bayer Pharmaceuticals. The Essure lawsuit alleges that the drug manufacturer marketed and produced a dangerous and defective medical device, and failed to warn medical professionals and the general public about the device’s dangerous side effects.

The Essure lawsuit was brought by Heather W., a resident of Michigan, who was implanted with Essure as a form of permanent birth control. The device is implanted for the purpose of blocking the fallopian tubes to prevent ovulation.

In the Essure lawsuit, Heather alleges that although the device is supposed to remain in the fallopian tubes, the Essure coils often migrate from the tubes, perforate organs, break into pieces, and/or corrode in the body. These events have the potential to wreak havoc on the female body.

According to the Essure lawsuit, after Heather had the Essure device inserted into her body, the wire coils migrated from her fallopian tubes to her uterus and rectum. This migration caused Heather to be hospitalized five times and eventually led to a hysterectomy. Heather further alleges that she now suffers from auto-immune and adhesion disorders due to the defective device.

Essure Problems

Essure is marketed as a nonsurgical alternative to permanent birth control. When Essure first entered the market, the federal Food and Drug Administration granted the birth control device conditional premarket approval and placed the device on a fast-tracked approval system.

Heather alleges that Bayer violated the terms of the conditional premarket approval and claims that the approval is now invalid. According to the Essure lawsuit, Bayer was cited by the Department of Health and the FDA for actively concealing and failing to report 8 perforations caused by the device.

The FDA also found that Bayer had under-reported side effects caused by Essure. According to the Essure lawsuit, Bayer only disclosed 22 perforations even though the company had knowledge of at least 144 perforations. The Essure lawsuit further claims that in May of 2013, the FDA uncovered an internal document showing over 16,000 unreported complaints associated with permanent birth control device.

Heather also alleges in her complaint that Bayer concealed and altered the medical records for its trial participants in order to manipulate the data to reflect a more favorable outcome.

Essure Lawsuits

Product liability attorneys are currently looking for potential plaintiffs to bring Essure lawsuits against Bayer Pharmaceuticals. The lawsuits generally allege claims for negligence, breach of warranty, violation of federal statute, and fraud and misrepresentation.

Awards and settlements from these lawsuits help hold the device manufacturers accountable for their actions, as well as serve as a reminder that these companies owe their consumers a duty of care. Damages from the lawsuits will also help victims pay both past and future medical bills.

Whether or not a lawsuit should be brought is a decision that should be made on a case by case basis with the advice of a legal professional.

The Essure Lawsuit is Case No: 2:15-cv-00384-GP, in the U.S. District Court in the Eastern District of Pennsylvania.