An Essure injury lawsuit has been filed after many other patients alleged serious side effects and dangers about which they claim they were never warned. The newest Essure injury lawsuit includes nine different plaintiffs, all women who say they used Essure as a form of birth control and suffered side effects.

Numerous Side Effects Alleged by Essure Users

Many of these women claimed that the manufacturer knew about the risks or should have known about the risks and failed to warn consumers about the dangers associated with the birth control device.

The device is intended to cause blockages of the fallopian tubes using micro inserts that cause tissue growth. According to the Essure injury lawsuit, the device can migrate from the fallopian tubes, perforates a patient’s organs, break into pieces, and even corrode to cause severe injury to the female body.

Conditional pre-market approval was initially provided by the Food and Drug Administration. The Essure injury lawsuit, however, says that Essure was misbranded, since defendants failed to report known hazards to the FDA, failed to comply with federal laws and regulations associated with distribution and marketing, and failed to meet regular reporting requirements.

The Essure injury lawsuit points to numerous notices of violations and FDA findings in support of these claims. The Essure injury lawsuit also says that defendants were cited by the Department of Health and the FDA for failing to make use of pre-sterile or post-sterile cages, erroneously using non-conforming material when manufacturing the medical device, actively concealing eight perforations that occurred in testing as a result of Essure, and manufacturing the birth control device for years without the proper license.

In 2013, the FDA discovered an internal Excel spreadsheet that had more than 16,000 entries for complaints that were never appropriately reported to the FDA as adverse event reports.

The plaintiffs participating in the Essure injury lawsuit claim that they were never told about the risk of serious side effects and injuries. These patients say that they began taking the medication with the belief that the medical device was appropriate and safe for regular usage as a form of birth control.

Many of these female patients were using Essure for a period of time in which they claim they were not aware of the risks. Most who have filed lawsuits say that they suddenly developed unexplained symptoms. The manufacturer is accused of failing to label the device properly or to warn patients about the possible problems.

Anyone who believes they may have grounds for an Essure injury lawsuit should consider consulting with an experienced attorney as soon as possible.

The Essure Injury Lawsuit is Case No. 2:18-CV-00503 filed in the United States District Court for the Western District of Pennsylvania.