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Essure Birth Control Lawsuit & Recall 2024

Last Updated: June 1, 2024

First marketed and sold in 2002, Essure quickly became a popular choice for birth control and female sterilization. The process involved the implantation of metal coils into each fallopian tube, inducing fibrosis and blockage of eggs, and thus acting as a permanent contraception method. Essure, which could be inserted in as little as 15 minutes, was promoted as a less invasive alternative to procedures like tubal litigation, which might require a general anesthetic before surgery. However, thousands of women soon began reporting serious Essure side effects and injuries, and there were dozens of deaths linked to Essure reported to the FDA. The Essure cases gained public attention through social media groups and a Netflix documentary, The Bleeding Edge. There was even a call for Essure market removal from celebrated lawyer Erin Brockovich. As a consequence, a huge number of Essure birth control lawsuits were filed against Bayer, the company that has manufactured Essure since 2013. In 2018, Essure was taken off the market.

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Bayer Essure Lawsuit

Conceptus manufactured Essure from 2002-2013 before being bought over for $1.1 billion by the multinational pharmaceuticals company Bayer in 2013. As was the case with Bayer’s purchase of Monsanto, which led to the Roundup weedkiller cancer lawsuits, Bayer soon learned that Essure came with a lot of problems. In the preceding years, almost 40,000 Essure lawsuits were filed against Bayer, which was potentially a determining factor in the company pulling the product off the market in 2018. While there might be some sympathy for Bayer in that it did not initially design Essure, the company is required to carry out due diligence on its products. Tens of thousands of women have claimed to have been injured by Essure, and there are reports of Essure-linked deaths. As the manufacturer of the product for five years, Bayer is accountable to those people who trusted it to deliver safe and effective birth control.

Essure Device
Image source: Wikipedia

Essure Risks - Updated 2024

  • After Essure, many women report experiencing pain and discomfort. This includes abdominal pain, back pain, or pelvic pain. Women have complained of pain that is so severe it interferes with their daily activities.
  • Essure coils can migrate from their original location within the fallopian tube. The coils can perforate nearby organs such as the uterus and intestines.
  • Nickel is a metal that some women are allergic to. Allergic reactions include hives, itching and skin rashes.
  • Unintended Pregnancies. Essure is intended to be a permanent contraceptive, but there have been reports that unintended pregnancy has occurred after the procedure. These pregnancies may be ectopic, which means they occur outside of the uterus. This can be dangerous.
  • Women have reported heavier menstrual bleeding following Essure. This can cause anemia, which negatively impacts a woman's life.
  • Perforation. The insertion of the Essure coils may lead to a perforation of your fallopian tubes, or of other structures nearby. This can result in internal bleeding that requires surgical intervention.
  • The physical and emotional effects of Essure complications may have a negative impact on the mental health of a woman. In some cases, anxiety and depression were reported.
  • Essure cannot be reversed, unlike other contraceptives. Removing coils can be a complex and dangerous surgical procedure, and the results of reversing them are not guaranteed.
  • FDA Actions. Due to an increasing number of reports about adverse reactions associated with Essure the U.S. Food and Drug Administration took several steps. The FDA required that the manufacturer Bayer add a black-box warning to the product's labeling, and they conducted a study of post-market surveillance. In 2018, Bayer finally announced it would stop selling Essure in the United States.

Essure Lawsuit News & Updates

  • June 1, 2024 - Essure patients organized to report their problems to the FDA.
  • May 1, 2024 - FDA puts restrictions on birth control implant but no recall.
  • April 1, 2024 - Plasma and peritoneal fluid cytokine profiles in patient with Essure implant: Towards a molecular signature?
  • March 1, 2024 - FDA Activities Related to Essure.
  • February 1, 2024 - Female urogenital devices used during their lifetime-managing menstruation including pelvic health.
  • January 1, 2024 - FDA received 6,000 reports about Essure in 2018 The FDA deemed the study on post-market surveillance of the controversial contraceptive device "adequate." The Essure arm has only 307 women enrolled.
  • November 1, 2023 - Netflix's The Bleeding Edge Exposes Essure, Mesh and Other Dangerous Devices.
  • July 19, 2023 - Clinical improvement after Essure devices removal: a systematic review.
  • July 1, 2023 - Essure removal surgery: Is preoperative Transvaginal Ultrasonography and pelvic X ray required?
  • May 1, 2023 - To monitor the safety of medical devices, FDA relies on reports about adverse events and product problems, FDA-mandated studies after market, and published literature. The FDA examines the information available about Essure, as well as the experiences of patients with Essure implants. The FDA reviews the information about Essure and the experiences of patients with positive outcomes as well as those who have experienced problems.
  • April 1, 2023 - Essure Retrieval Analysis - Micro Insert Female Sterilization Implant: Methods for Metal Ion and Microscopic Analysis
  • March 1, 2023 - Bayer is accused of failing to report contraceptive complaints. Contraceptive was reportedly responsible for thousands of women's suffering from pain, bleeding, and organ damage.
  • February 19, 2023 - 5 signs your Essure birth control device needs to be removed. These are five common signs that Essure needs to be removed:
    • Heavy bleeding or irregular bleeding, even bleeding between periods
    • Chronic headaches, dizziness or fainting
    • Chronic, severe pelvic pain and cramping
    • Persistent nausea or vomiting
    • Pain or discomfort from sex can cause chronic pain
  • February 1, 2023 - Bayer to pay $1.6B to settlement 90% of Essure injury claims.
  • January 1, 2023 - Reported Essure device complications

    Although there is a low risk of complications or side effects from the Essure, some women have had the following complications:

    • Failure to place the Essure, including perforation in the wall of your uterus, bladder, or bowel.
    • The device may migrate to other areas in the abdomen and pelvis
    • The possibility of developing an allergy to nickel, or any other metal.
    • Device fragmentation during implantation or removal
    • Unintended pregnancy includes ectopic pregnancy (pregnancy occurring outside of the uterus).
    • A gradual increase in pelvic pain that lasts longer than three months.
    • Changes in blood loss and frequency

    The rates of abnormal uterine bleeding and abdominal pain are slightly higher when compared with laparoscopic tubal ligation.

  • December 15, 2022 - Out of 804 women who had Essure devices placed:
  1. 541 (67.29%) remained asymptomatic
  2. 263 (32.71%) developed gynecological symptoms
  3. 41 of these (15.5% of the total sample) requested Essure surgical removal due to pelvic pain and bleeding.
Essure Survey
Source: Pubmed
  • December 1, 2022 - Bayer pharmaceutical agreed to a $2.5 billion settlement with American women over their horrific experiences with its contraceptive implant Essure device.

The most important Essure lawsuit update is arguably the settlement agreement for Bayer to pay $1.6 billion to claimants in August 2020. This was regarded as a resounding success for the Essure lawsuits, although Bayer did not admit any fault as part of the settlement. The important question is, what happens next? Bayer’s Essure settlement covered around 90% of lawsuits filed at the time, but there is scope for more claimants to file lawsuits against Bayer for Essure. Indeed, the FDA updated its Essure advice webpage in October 2022, detailing the progress of Essure removal procedures in the United States. Also of note is that Essure was marketed internationally, and women in other countries are also pursuing Essure implant lawsuits. For instance, lawsuits were filed in Brazil in 2022, and the United Kingdom in 2020.

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Essure Recall 2022

There currently isn’t an Essure FDA recall in place. Essure was removed from the market in the United States in 2018. However, after the reported problems with Essure, many women are electing to have the Essure implantation removed. There are numerous reasons to have an Essure removal procedure, including an attempt to reverse sterilization. However, many women have chosen to have the removal due to Essure’s side effects. The problem, though, is that there are also potential Essure removal side effects, leading to more pain and suffering in women who have already faced Essure complications.

Essure FDA Recall

As stated, the FDA has never made an official Essure recall. However, the government watchdog has sounded several warnings over Essure over the years. This includes the addition of a so-called Black Box Warning applied to Essure. A Black Box Warning – also known as a Black Label Warning – is an FDA initiative used to warn patients and healthcare professionals of possible complications, dangers, and adverse reactions to certain drugs and medical procedures. Please note, while there was no official Essure recall by the FDA, the watchdog did provide guidance to healthcare providers that all unused Essure implant units should have been returned to Bayer by December 31, 2019.

Essure Complications & Side Effects

Essure Complications & Side Effects

Essure injuries, complications, and side effects have been widely reported on multiple platforms. At the time of writing, the Essure Problems Facebook Group has over 40,000 members. But this is just one group, and many more similar groups have launched on social media in different regions of the world. The list of Essure problems is broad. Some will be particular to small numbers of women, while others are more widespread. Below we list some of the common Essure side effects and complications:

Essure Side Effects List

  • Pain/Discomfort, particularly in the abdomen, pelvis, or back
  • Fatigue
  • Weight Loss
  • Bleeding
  • Hair Loss
  • Depression
  • Allergic reactions
  • Perforation (tears in fallopian tubes)

In addition, the FDA lists both long-term and short-term Essure side effects. Below we have broken these down into two categories. Please note that both long-term and short-term side effects and complications can overlap:

Essure Side Effects After 10 Years

  • Chronic pain
  • Perforation
  • Allergic reactions
  • New surgery required
  • Unintended pregnancy (see below)

Essure Side Effects After 5 Years

  • Cramping
  • Bleeding
  • Nausea
  • Dizziness
  • Headaches
  • Pain & Discomfort

Nickel Poisoning Symptoms From Essure

It has been reported that Essure inserts can cause nickel poisoning, although the direct link between Essure and nickel poisoning has also been contested in studies. Nevertheless, because the device is partly composed of nickel, some experts have warned about the nickel poisoning risk. The Mayo Clinic lists the following symptoms of nickel poisoning:

  • Rash or bumps on the skin
  • Redness
  • Itching
  • Dry patches
  • Blisters

Essure Contraceptive Complications

It is commonly held that no contraceptive solutions can be deemed 100% effective. The common claim about Essure’s effectiveness was that it had a 99.8% success rate of preventing pregnancy. However, this claim has been contested by women opening lawsuits against Essure for unwanted pregnancy. Indeed, the FDA points to clinical studies that show that approximately 8% who undergo Essure implantation cannot rely on the device for birth control.

Bayer Essure Settlements & Payouts

There have been large-scale campaigns to secure compensation for women suffering from Essure implant complications. Indeed, Essure justice became a celebrated campaign in the news media due to activists working on social media, as well as the release of documentaries on Netflix. This all led to a raft of lawsuits against Bayer. In 2020, Bayer agreed to pay $1.6 billion in compensation to settle around 90% of the Essure birth control lawsuits. As of late 2022, Bayer has not settled all the Essure cases, and it is still facing legal action for Essure in the United States and abroad. If you believe you have been injured by Essure, you should contact an Essure injury lawyer to find out about your eligibility to secure compensation.

Essure Settlement Payout Amounts Per Person

In the first Bayer Essure payout of $1.6 billion, it was estimated that each claimant received somewhere in the region of $35000-$40000 per claim. This was based on the figure of around 40,000 claimants in the Bayer Essure lawsuit. While this does not mean future Essure lawsuits will secure that figure for new claimants, it serves as a useful reference point for a possible Essure payout award.

Essure Injury Attorney

If you have been injured by Essure or are experiencing complications with the products, you might wish to speak to an Essure injury lawyer. As mentioned, Bayer has already agreed to pay around $1.6 billion in settlement money to claimants in previous Essure lawsuits. Essure injury law firms have already successfully secured compensation, so anyone with a claim should contact an attorney for expert advice on how to proceed.

How Do I Join the Essure Lawsuit

While Bayer has agreed to pay compensation to settle 90% of the Essure lawsuits brought by various law firms, it is still possible that those injured by Essure can pursue individual lawsuits. The best course of action is to speak to an experienced lawyer to see if you are eligible to make a claim.

Is Essure a Class Action Lawsuit or a Mass Tort Lawsuit?

Currently, the Essure lawsuits are not grouped together as a class action or mass tort. The settlement from Bayer in 2020 was used to pay a large group of claimants (around 40,000) to settle out of court. It is possible that more of the current Essure lawsuits become grouped together in a class action or mass tort case. Both types of litigation are used to group large numbers of cases together to streamline the process through the courts.

Essure Lawsuits FAQs

What Is Essure?

Essure is a metal coil implant used as birth control. The product was first launched by Concepto in 2002, which was later bought by Bayer in 2013. After years of campaigning and lawsuits, Essure was removed from the market in 2018.

What is the Essure lawsuit about?

The Essure lawsuits were filed after thousands of women experienced problems, including injuries and side effects, linked to the birth control implant.

Is there a recall on Essure?

There is not currently an Essure recall. However, the FDA issued warnings about the product. Essure was removed from the market in the United States in 2018.

When Will Essure Settlements Be Paid?

In August 2020, Bayer set aside $1.6 billion to settle 90% of Essure lawsuits. If you are still waiting on your Essure payout award, you should contact your Essure law firm representative for advice.

Can You Get Pregnant With Essure?

No contraception method offers 100% results. Essure claimed to prevent 99.8% of pregnancies, although this was contested in the Essure lawsuits.

Why Was Essure Taken Off The Market?

Bayer claimed Essure was taken off the market due to a lack of demand, something that was perhaps linked to the Essure complications awareness campaigns.

What problems does Essure cause?

Women who have used Essure have reported numerous problems and side effects. You can get the full list of Essure dangers on the FDA website.

Can you still sue Essure?

While Bayer settled 90% of Essure cases and no longer makes the product in the United States, it is still possible to pursue legal action against the company if you have been injured by Essure. For further advice, including your rights under the statute of limitations, contact a personal injury attorney.

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© Copyright Jazz Media Ltd. 2024. All rights reserved

About us

We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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© Copyright Jazz Media Ltd. 2020. All rights reserved