After initial reports of serious Essure side effects two years ago linked with the birth control device, the U.S. Food and Drug Administration (FDA) added a warning label to alert patients.

But the FDA has continued to receive reports of other Essure side effects that patients claim they have not been adequately warned about, and the agency has begun investigating these new reports as well.

Essure Basics

The Essure birth control device was designed as an alternative for women who wanted a permanent birth control option, but did not want to undergo surgical tubal ligation. According to Bayer, around 750,000 women have been implanted with the Essure device since its 2002 FDA approval.

The Essure system is made up of two metal coils lined with a thin fabric. The coils are placed in a woman’s fallopian tubes. After the initial procedure, it takes a few months for the coils to become effective, as time is required to allow the coils to expand and for the surrounding tissue to grow in around them, completely blocking the fallopian tubes and preventing pregnancy.

Essure is advertised as a simple, quick implantation procedure that can be done in a doctor’s office, and doesn’t require invasive surgery, incision or anesthesia.

Although the Essure device is marketed as a safe and effective form of birth control, lawsuits allege that there are actually serious Essure side effects linked with the drug.

Essure Side Effects

In 2016, the FDA responded to thousands of complaints of Essure side effects by slapping the device with the strongest safety warning label available.

The federal agency also asked that the device’s manufacturer, German drugmaker Bayer, conduct a post-market study regarding these complications.

Many Essure side effects are fairly minor, and include complications like headaches, dizziness, vomiting, cramps, abdominal or back pain, fatigue, weight fluctuation and pain during sex. Major Essure side effects include implant failure, device migration, organ perforation, device fracture and ectopic pregnancy.

According to these reports, a few new Essure side effects have been linked with the device during removal. The FDA received nearly 12,000 reports of Essure side effects in 2017 alone. Nearly 90 percent of these recent reports included problems stemming from Essure removal, the FDA noted.

Filing a Lawsuit Over Essure Side Effects

According to Essure lawsuits, Bayer failed to adequately warn patients and the medical community about these major Essure side effects. Plaintiffs allege that, had they been adequately informed of these complications, they would never have been implanted with an Essure birth control device in the first place and avoided these risks altogether.

If you or someone you love has suffered from any of these or other Essure side effects, you may be able 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.