Women interested in pursuing a legal claim over Essure complications should seek legal advice as soon as possible to meet an upcoming deadline.

Following the FDA’s issuance of an Essure black box warning in February 2016, an upcoming settlement will require claimants to file their Essure lawsuits by February 2018. It can take several weeks from initial contact with an attorney before a lawsuit can be filed. Potential claimants should reach out as soon as possible by filling out the form on this page.

New Essure Mass Tort Lawsuit Filed in Missouri

A black box warning is the strictest of FDA warning labels, issued when there is evidence of a significant risk associated with a drug or medical device. The Essure black box warning was added in 2016, alerting patients and doctors about the significant dangers associated with Essure birth control implants.

The complications at issue have been the subject of thousands of Essure lawsuits filed against Bayer. One of the more recent Essure mass tort lawsuit was recently filed in Missouri by plaintiffs from across the country. This mass tort lawsuit was filed on multiple counts, including negligence, failure to warn, manufacturing defect, common law fraud, fraudulent concealment, breach of express and implied warranties, and several others, as well as applicable state laws.

According to Essure lawsuits, including this one, Bayer failed to adequately warn patients and the medical community about the risk of these Essure adverse events, and instead chose to actively withhold this valuable information. Plaintiffs claim that, had they been given adequate warning about the risk of these complications, they would have chosen a safer alternative than the Essure birth control device and avoided these risks altogether.

What is Essure?

The Essure device consists of two metal coils lined with a thin fabric, which are implanted in the fallopian tubes during a quick outpatient procedure. After implantation, the coils expand into the surrounding tissue, and the tissue grows in around them. This new growth is intended to completely block the fallopian tubes and prevent pregnancy. A few months after the procedure, the device becomes effective.

Essure was created back in 1998 by Conceptus Inc. and was approved by the U.S. Food and Drug Administration (FDA) in 2002. Conceptus was later purchased by Bayer Healthcare.

Permanent birth control is a growing market in the United States. Around 700,000 American women undergo tubal ligation each year, so adding another option—Essure—to the market would likely be a lucrative move. Indeed, this mass tort lawsuit claims that Conceptus created Essure primarily to pull the company out of millions of dollars of debt, allegedly marketing the device primarily for company profit without concern for patient safety.

The effort to promote Essure was successful: in 2013, Essure was valuable enough that Bayer bought out Conceptus for over $1 billion.

Plaintiffs claim that in order to best promote its new birth control device, Conceptus—and later Bayer—chose to actively suppress information about the adverse effects associated with Essure. In fact, the company was cited several times for withholding safety information about Essure, the lawsuit claims.

Despite the popularity and widespread use of Essure, a growing number of women are coming forward with claims of serious problems. Over 30,000 women belong to a Facebook group called “Essure Problems” that acts as a support group for women affected by Essure side effects. More than five thousand people have reported these side effects to the FDA, and some have chosen to pursue litigation over a number of complications.

Essure Adverse Events

Any medication or medical device will come with certain side effects, but Essure patients claim that their Essure adverse events are far more serious than they ever expected or were warned about. Other than the expected mild side effects like headaches, vomiting, and fatigue, patients have also reported more major problems like implant failure, device migration, organ perforation, device fracture, and ectopic pregnancy, any of which can have permanent effects. The 2016 Essure black box warning was added to emphasize the severity of these risks.

For some, these more major Essure adverse events like those included in the new Essure black box warning may require removal surgery to fix. Of course, removal surgery itself brings with it further risks of its own.

The Essure Lawsuit is Case No. 4:17-cv-02774-JAR, in the U.S. District Court for the Eastern District of Missouri.