Essure is a type of female sterilization device designed to create permanent birth control for women. Essure was removed from the market, and since its release, it has created numerous health complications for women who use it.
If you are one of the thousands of women injured after using this device, you may be entitled to financial compensation. Join the Many to learn if your case qualifies and how we can guide you through the entire process of holding device makers accountable. We can connect you with attorneys who are already helping women get the compensation they are owed.
What Is Essure?
Essure is a birth control device, specifically a type of metal coil designed to fit into the fallopian tubes. The Essure System for Permanent Birth Control, developed by Conceptus Inc. and later acquired by Bayer AG, was approved by the Food and Drug Administration (FDA) in 2002 as an alternative to more invasive tubal ligation procedures. The device aims to create a blockage in the fallopian tubes, promoting the development of fibrosis to prevent pregnancy.
However, Essure has been the subject of significant controversy and adverse event reports. Some users have experienced issues related to the device operating differently than intended, leading to patient-device incompatibility.
These complications have resulted in Essure claims and legal action against Bayer, the manufacturer. Despite its initial promise of providing a less invasive birth control option, concerns about adverse effects have raised questions about the safety and efficacy of the Essure birth control device.
What Is the Process for Using Essure?
The Essure procedure involves the placement of the Essure device into the fallopian tubes, and a number of complications have been associated with this process. Physicians use a catheter passed through the vagina, cervix, and into the uterus to carefully position the Essure coils. The complexity of this procedure requires a significant amount of skill to ensure proper placement of the Essure devices.
After insertion, ingrowth of tissues in the surrounding area occurs over approximately three months. This leads to the formation of a blockage in the fallopian tubes, serving as a barrier that prevents sperm from reaching an egg.
The intended result is the elimination of the risk of pregnancy for most women. Notably, the Essure procedure was designed to be less invasive and generally less painful, often performed in a doctor’s office without the need for anesthesia.
Despite these intentions, Essure has been associated with adverse events and complications, leading to Essure claims and filed lawsuits. Some users have reported issues such as menstrual irregularities and perforated organs.
In response to the reported complications, there have been settlements related to Essure claims, highlighting concerns about the safety and efficacy of the Essure medical devices. Training using Essure simulators has been implemented to address the skill required for the procedure and reduce the risk of injury reports associated with Essure.
How Popular Was Essure?
Essure was sold throughout the world, including in 23 countries. In total, about 750,000 of these devices were used globally, according to the New York Times. The company does not report on how many women in the U.S. had the devices placed, but it did state that complications from the procedure are considered very rare.
However, there are more than 39,000 women who have pending lawsuits as a result of their use of Essure. If you suffered losses after having a device implanted, Join the Many can help. Let us help you determine if you are owed compensation.
What Caused the Problems for Women?
Many women used Essure as a way to get birth control, which the company promised a 99.74% rate as a permanent birth control method, calling it, according to the Washington Post, the most “effective method for permanent birth control available.”
Essure also was promised to be gentle and easy to be placed. It was stated to be an alternative for tubal ligations, which created surgical scars and required anesthesia.
Women suffered a number of complications from their use of Essure. Some examples of this include:
- Metal allergies
- Severe and chronic pain
- Perforation of the uterus, colon, or another organ
- Scar tissue
- Unintended or unwanted pregnancy
- Hysterectomy is required as a result of the procedure to remove the device
- Device breakage and migration in the abdomen
- Menstruation problems
- Ectopic pregnancy
- Fetal death – 21 children during pregnancy and 2 additional children died after birth
- Adult death – 4 women died from complications of using Essure
Essure and FDA Notices
Essure is no longer on the market. It was removed by Bayer, who stated it was removing the product due to low demand and sales. However, a great deal led up to this in the years following the release of the product. The FDA documents all of the following instances online.
From 2011 to 2013, an estimated 16,047 complaints were made to the FDA regarding the product when Conceptus manufactured it. At that point, the FDA did not take action, but there are demonstrated cases of complaints that even date back to the initial release of the product.
In February 2016, the FDA took action after receiving many more than thousands of complaints about the product. At that time, they required Bayer to complete a new clinical trial with an effort to determine if some women would be at a higher risk than other women, based on the numerous reports they received.
The safety trial for the product enrolled 269 women between the ages of 23 and 45. The device was successfully implanted in 200 of those individuals. In those situations, 9 women experienced perforation of the fallopian tube during the insertion process, which was later expelled or lodged somewhere else in the body, according to the New York Times. Of those women in the study who were asked to maintain a journal, 1 in 10 of them reported complications, including painful intercourse or painful menstrual periods during the first three months.
An additional study was done on 518 women, of which 449 were able to rely on the device. In those situations, 21 women suffered a perforated fallopian tube, or the device was expelled or found in another area of the body. In this group of women, at least 8 had to have surgery to remove the device, often leading to a full hysterectomy.
In November 2016, the FDA then took additional action, this time requiring Essure to have a black box warning label added to it. This warning label does not prevent the use of the device but instead simply requires a label to be provided to alert patients to the possible risks associated with the use of the device. The FDA’s label requires that consumers be alerted about the risk of perforation, abdominal pain, allergy risks, and other potential concerns.
In April of 2018, the FDA stated it had received a total of 26,7000 complaints about the product ranging from as early as 2022 through 2017. As a result of this, the FDA took steps to restrict the sale of the device in April 2018.
In December 2018, Bayer announced that it was pulling the product from availability. It is essential to know that procedures did not stop at that point. That’s because healthcare providers who purchased the devices for their patients had a full year from purchasing them to use the device. As a result, many women had the device placed in the year following the removal from the market.
Once Bayer removed the product from sales, the FDA created a post-market surveillance plan for the device. It created a new method for follow-up on the patients who continued to use the device.
What Are Common Side Effects of the Use of Essure?
Women who used Essure suffered a number of health complications. Though complications did not happen in all situations, and the vast majority of situations did not result in health complications, for many women, those complications were numerous and high-risk. Most side effects women experienced, such as discomfort and pain, were gone within a few days.
However, some women suffered significant results, including:
- Chronic pelvic pain
- Heavy bleeding
- Bowel-related problems
- Allergic reactions to the metals
- Perforations that required surgical removal
Some women reported the coils breaking, which then allowed them to cause damage to other areas of the body and tissues in the region. Some also noted that the devices moved out of the fallopian tubes and were found in the uterus, pelvis, or other areas of the body. Some also suffered perforations of organs while the device was being placed, including punctures of the fallopian tubes, uterus, or bowel. Others suffered chronic pain that was so significant that they had to have the device removed through a much more invasive surgical procedure.
Is Essure Still Used Today?
Essure is no longer available for sale or implantation in the U.S., and Bayer, the company responsible for Essure, mandated healthcare providers to return all unused products by the end of December 2019. Despite its discontinuation, many women still have the Essure device in place.
The FDA does not recommend the removal of the device for women unless they are experiencing health complications that necessitate more advanced treatment to address the issue.
If you are currently using Essure and are facing health complications, it is important to be aware of your legal rights. Many lawsuits have been filed against Bayer due to severe pain, broken devices, abnormal bleeding, and other issues associated with Essure.
Those experiencing multiple surgeries or adverse effects are encouraged to seek guidance from legal professionals who can help them understand their options for taking action against the manufacturers.
What Essure Lawsuits Are Occurring?
There are many instances of women filing a lawsuit against Essure as a result of the complications they experienced while having the device inserted or in the months after doing so.
In 2016, a number of people came forward to report the complications from the condition, and, as a result, legal action was taken. Initially, a judicial panel on multidistrict litigation (MDL) was put into place. However, after this petition, which contained 28 claimants, a judge in the Eastern District of Pennsylvania agreed to hear the case considering that 23 of those claims had been filed in the state. That caused the MDL to be withdrawn.
However, there are numerous other litigations pending throughout the U.S. There are lawsuits pending in state and federal courts throughout the U.S. However, there has not been a federal class action lawsuit put into place just yet.
If you have suffered any type of loss related to Essure use, Join the Many can help. Don’t wait to find out if you are owed money.
What Essure Settlements Have Occurred in Essure Cases?
It is very common for these types of Essure lawsuit settlements to be kept quiet, especially since most of them have been settled outside of court. However, there are a number of different claims present. For example, according to Bayer’s 2019 annual report, the company paid out $413 million in claims for Essure, which includes all legal problems related to the use of the device. In later years, the financial reports do not specifically state additional claims paid for Essure, though there are notable “legal risk” costs in the millions of dollars paid by the company.
It is likely that additional compensation may be paid out to those who suffered losses due to the result of Essure use. However, those losses noted in financial reports do not indicate that much was paid to claimants but rather for all costs associated with legal actions regarding Essure.
What Should You Do If You Were Harmed by Essure and looking for an Essure Lawsuit Settlement?
The FDA continues to monitor for any claims made against Essure. If you have health complications that you believe are from Essure, your first step should be to speak to your doctor to discuss what is occurring. The proper treatment can then be provided to help protect your health.
From there, Join the Many to help ensure this doesn’t happen to anyone else. We want to hear your story and offer insight into what legal steps may be available to you, including how we can make it easy so you can focus on your health and your family.
You would have the right to compensation if Essure caused you financial loss, chronic pain, and other losses. We can determine if you qualify, then match you with attorneys who are already working on claims like this. You’ll pay no legal fees unless you’re awarded compensation.