Many patients allege they were never told about the serious injuries associated with the birth control through an Essure black box warning.

Some patients who have suffered side effects due to the lack of an Essure black box warning have opted to file lawsuits.

Background of Essure

Essure is a popular birth control device, but some of those implanted with Essure have reported experiencing major problems that they say they were not warned about.

Since Essure’s approval by the U.S. Food and Drug Administration (FDA) in 2002, around 750,000 people have so far been implanted with the Essure device. Essure consists of two metal coils lined with a thin fabric, which are placed within the patient’s fallopian tubes. The procedure is quick and noninvasive, requiring no incision or anesthesia, and is often done in a doctor’s office in an outpatient procedure.

Unfortunately, more and more patients are reporting suffering from a wide range of serious complications after implantation with Essure, and allege that they were not given adequate warning about these risks from promotional material or even the Essure black box warning.

Essure Users Ask For Device Ban

A group of women affected by Essure side effects has banded together to spread the word about the device’s dangers. The group of women, known as the E-sisters, have reported experiencing a wide variety of side effects, from bleeding to pelvic pain to rashes and more.

The U.S. Food and Drug Administration’s Commissioner Scott Gottlieb met with this group of women in March to discuss problems with Essure. The women shared evidence and personal anecdotes of how Essure has negatively affected them and thousands of others in a similar situation. The women were hoping that Gottlieb might agree to a ban on the use of Essure devices in the U.S. (It’s worth noting that the U.S. is now the only country in which Essure is still available, after Bayer removed the device from its other market, though the manufacturer claims this is because of commercial reasons rather than any safety concerns.)

At the time, the women recall being told that there was potential for a ban, but Gottlieb later informed them that Essure would remain on the market.

Although the FDA declined to ban the device outright, there is still potential for the FDA to take other steps towards making Essure safer for patients and alerting them to risks. An Essure black box warning was added to the device a few years ago to emphasize its risks.

Now, the FDA “is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device,” it said in a statement. According to the federal agency, it received 12,000 reports of Essure complications in 2017 alone. “We’re working to evaluate whether these cases reflect new safety concerns,” Gottlieb noted. New safety concerns could mean updating the current Essure black box warning.

Complications that have been reported from the use of an Essure device include implant failure, device migration, organ perforation, device fracture, and ectopic pregnancy, among other side effects. Some patients who suffer from these kinds of Essure problems require removal surgery to alleviate complications, but removal surgery carries with it its own risks.

Filing an Essure Lawsuit

According to Essure lawsuits, Bayer Healthcare failed to adequately warn patients and the medical community about the risks of Essure, even through the Essure black box warning. Plaintiffs allege that, had they been adequately informed of the device’s risks, they would never have been implanted with an Essure birth control device and avoided these risks altogether.

If you or someone you love has suffered from any of these or other Essure complications, 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 problems, it can help to alleviate the financial burden caused by medical expenses and lost wages.