Lawsuit Filed Against Potentially Harmful Device Essure

Women rely on a variety of birth control methods, including medically implanted devices, to prevent unwanted pregnancies and give them the peace of mind that they need. Unfortunately, many women who relied upon the Essure birth control device have experienced serious complications. Some users of Essure have reported serious internal injuries after the device moved from its intended location in the fallopian tubes and migrated to other parts of the body. Some of these injured women are fighting back and seeking to hold the medical device manufacturer accountable.

The law firm of Bubalo Law PLC recently filed a lawsuit on behalf of dozens of women in multiple states, all of whom have suffered severe injuries after having the Essure device implanted. The women are alleging that Bayer Pharmaceuticals marketed Essure as an entirely safe device and misrepresented the risks associated with the birth control device. If successful, the lawsuit could help the women secure substantial compensation for the injuries and pain and anguish they have endured and send a strong message to pharmaceutical companies that misrepresenting the safety of medical devices is outrageous and won’t be tolerated.

How Essure Birth Control Works

Essure is a form of permanent birth control. The idea is to create a natural barrier inside the body that prevents eggs from being fertilized. The device is a tiny spring not unlike the springs found inside ballpoint pens.

A spring is implanted through the vagina into each of the fallopian tubes. If the springs stay in place as intended, then over the course of about three months, the body will grow tissue around the springs that will result in a blockage of the fallopian tubes. Since sperm will not be able to reach the eggs, a successful blockage will make it impossible to become pregnant.

Complications may occur however if the spring dislodges, leaves the fallopian tubes and moves elsewhere in the body.

Harmful Side Effects of Essure

The lawsuit alleges that Bayer failed to warn women about the risk that Essure does not always stay in place. In some cases, the device can become dislodged and migrate inside the body, potentially injuring the fallopian tubes, the uterus, and other organs, as well as nearby arteries.

The symptoms associated with the movement of the device include:

  • Severe abdominal and/or pelvic pain
  • Autoimmune disorders
  • Device breakage and/or displacement
  • Unusually heavy bleeding

When Essure dislodges and perforates nearby organs or arteries, it can cause heavy bleeding and require additional surgical procedures. If you have experienced any of the above symptoms after having Essure implanted, you may want to contact Bubalo Law PLC to discuss your legal options.

Essure and the FDA

Essure first entered the market in 2002. Since then, thousands of women have filed reports with the U.S. Food and Drug Administration (FDA) alleging serious injuries after having the device implanted. In 2015, the FDA assembled a panel of experts to consider whether the reports warranted further regulation of Essure.

In 2016, the FDA required the manufacturer to place a ‘black box’ warning label on the product, but allowed it to continue to be marketed and sold.

In April, the FDA placed additional restrictions on the sale of Essure. The FDA announced that it would only allow the sale and implantation of Essure by healthcare providers that agreed to review a 22-page brochure with patients considering the device.

This brochure, entitled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” details the risks associated Essure. Doctors are required to provide patients with the brochure and to review the information to be sure that the patient is well informed of the risks before selecting Essure.

Bayer has withdrawn the device from the market in Canada, but is continuing to sell it in the United States.

Victims of Essure fight back

Since Essure entered the market, more than 16,000 women injured by the device have filed lawsuits against Bayer. The lawsuits allege that the manufacturer failed to inform women of the risk of injury associated with Essure and is fraudulently marketing a medical device that can cause serious harm as a safe device.

Many of the women who joined Bubalo Law PLC’s lawsuit have suffered significant medical complications after having Essure implanted. One of the plaintiffs had to have a hysterectomy, including the removal of her fallopian tubes, due to her injury.

Connect with an Essure injury lawyer today

If you have developed complication after having Essure implanted, you don’t have to face this difficult time alone. You may have legal options. Whatever serious side effects you are experiencing — from abdominal pain to unusually heavy bleeding to the necessity of additional surgical procedures— you may be able to demand compensation through an Essure lawsuit to cover your medical bills from the manufacturer of this unsafe medical device.

You could win compensation for the costs of medical complications, pain and suffering, and more. Don’t delay: this process is time-sensitive. The statute of limitations for filing civil lawsuits in your state will prevent you from filing a lawsuit if you wait too long.

The medical device attorneys of Bubalo Law PLC have years of experience fighting manufacturers for marketing and selling dangerous devices that cause serious injuries to unsuspecting consumers. For more information on how we can help you with your Essure implant problems, read our page about Essure lawsuits. To set up a free case review, call us today at (800) 377-5163.