A new lawsuit says Essure coils caused severe and painful side effects for a woman. Rocio R. and Jose M., plaintiffs, have initiated an Essure coils lawsuit against Bayer, the manufacturer of the permanent birth control device.

Recently, Bayer decided to pull the Essure coils from the marketplace amidst rising lawsuits against the company naming a variety of serious side effects for women who opted for the permanent birth control. The company shared in the promotion of their decision that weak sales had led to the outcome of taking Essure off the market in the U.S., the only remaining country in which it was available.

In May, the FDA required that doctors discussing Essure with their patients go through a checklist of the possible issues and side effects of Essure coils before allowing a woman to receive the device as their selection for permanent birth control.

The Essure coils lawsuit says that the plaintiffs sustained severe and permanent injuries as a result of using Essure, the FDA approved medical device for permanent birth control.

Essure Complications

The Essure coils lawsuit points out that Essure was approved by the FDA through a rigorous pre-market approval process in 2004. Additional supplemental approvals were provided by the FDA since then, but the plaintiff points out in her lawsuit that the Essure coils caused severe and painful injuries about which she was never warned in advance.

The Essure device is intended to cause bilateral occlusion, also known as blockage of the fallopian tubes by using micro-inserts which illicit tissue growth and cause the blockage. However, as the plaintiff explains in her Essure coils lawsuit, the device can migrate from the tubes and can perforate organs, can break into pieces and can also corrode. All of these Essure side effects cause severe problems for plaintiffs.

Rocio’s Essure lawsuit says that the Essure coils fractured and migrated and even punctured internal organs. She adds that these complications put all users of the device at risk.

The Essure coils lawsuit points out that the defendants were previously cited by the FDA and the Department of Health for violations in their original approval order including manufacturing Essure at an unlicensed facility, using non-conforming material erroneously in the manufacturing, failing to choose pre-sterile and post-sterile cages, and failing to report eight perforations that happened as a result of Essure, among others.

As of 2013, the FDA identified an internal Excel spreadsheet that had more than 16,000 entries for adverse event reports and complaints that were allegedly not reported to the FDA appropriately. Many of these were associated with injuries from the Essure coils breaking down and perforating parts of the patient’s body.

The FDA launched an investigation against Bayer, Essure’s manufacturer, to ensure the device’s safety.

The plaintiff alleges that she was never told in the process of evaluating birth control options that she may be more likely to suffer permanent or lasting side effects as a result of these conditions and, therefore, was unable to make an informed decision about the device.

The Essure Coils Lawsuit is Case No. 2:18-cv-04250-JP filed in the United States District Court for the Eastern District of Pennsylvania.