Bayer Healthcare has announced that it will bring an end to Essure sales outside the U.S., and safety experts expect that this decision will soon move to Essure sales in the U.S. as well.

Bayer claims that its decision to stop these Essure sales was based on commercial reasons, saying that “there is not as much patient interest in permanent birth control” in markets outside of the United States.

Though the company claims its decision is not related to safety issues, Essure has certainly been deeply embroiled in safety problems for years. The U.S. Food and Drug Administration (FDA) mandated a black box warning label—the highest alert level—to inform patients of the risks of Essure back in 2016.

Essure sales were suspended in Canada and several other countries this last May. The suspension of Essure sales came after a slew of reports involving a number of Essure side effects, from allergic reactions to abnormal bleeding and from perforation of fallopian tubes to revision surgery.

Patients and safety advocates have called for the FDA to stop Essure sales in the U.S. market due to the serious risks that have been associated with the device. Many have demanded more research into these side effects.

“What’s particularly important to patients who do have Essure is that there be research as soon as possible to show them what the risks and the benefits are over the long term regardless of what country is still selling Essure,” said Diana Zuckerman, who is president of the National Center for Health Research.

Some safety experts have expressed the opinion that Bayer’s decision to stop Essure sales in European markets may indicate that it will soon pull the device from the U.S. market as well.

Erik Gordon, a University of Michigan professor at the Ross School of Business, told Modern Healthcare that “the product isn’t important enough commercially for Bayer for it to continue throwing money at lawyers to keep it on the market.”

And Bayer certainly has been spending a lot of money on litigation. Last year alone, Bayer spent around $413 million defending the product and themselves in a pile of litigation. While Essure sales are still substantial—around 750,000 devices total, and $48 billion in sales just last year—the litigation continues to grow. Thousands of women have already filed lawsuits against Bayer over Essure side effects, and more keep piling on.

Essure Device Basics

Essure is a popular form of permanent birth control, a device made up of two metal coils lined in a thin fabric and placed in a woman’s fallopian tubes in an outpatient procedure. Essure was designed as an alternative to other permanent birth control methods like surgical tubal ligation. Essure was first approved by the U.S. Food and Drug Administration (FDA) back in 2002.

While side effects should be expected from any medication or medical device, many patients who were implanted with Essure claim that the Essure complications are more harmful than reasonable expectations allow. Indeed, thousands of women have reported serious Essure side effects since the device’s approval. The FDA reports having received over 5,000 reports of Essure side effects.

Major Essure side effects include:

• implant failure
• device migration
• organ perforation
• device fracture
• ectopic pregnancy

Any of these side effects can be quite serious and have dangerous and lasting effects. Some patients who suffer from these kinds of Essure adverse effects require removal surgery, but removal surgery carries its own risks, as well as additional medical expenses.

Filing an Essure Lawsuit

According to Essure lawsuits, Bayer Healthcare failed to adequately warn patients and the medical community about major Essure complications, placing patients at risk.

If you or someone you love has suffered from Essure side effects or any of these other complications after being implanted with the birth control device, you may have cause to file an Essure lawsuit against Bayer. While filing a lawsuit cannot take away the pain and suffering caused by Essure side effects, it can help to compensate for the financial cost of medical expenses and lost wages.