The Essure controversy has sparked widespread media attention. The problematic implant has affected women around the world, leading to severe health complications and legal actions.
Written by :
Gregory Parker
Edited by :
Grace Johnson
Bayer Announces $1.6 Billion Settlement
On August 20, 2020, Bayer announced a monumental $1.6 billion settlement to address approximately 90% of the nearly 39,000 claims filed in the United States concerning injuries allegedly caused by Essure. This settlement, which did not include an admission of wrongdoing or liability by Bayer, aimed to resolve a significant majority of the litigation, allowing the company to refocus on its commitments to women’s health amidst ongoing controversy over the device’s safety.
Centralization of California Lawsuits
In a significant legal development during October 2016, a California judge ordered that numerous Essure lawsuits be centralized in the Alameda County Superior Court as part of a Judicial Council Coordinated Proceeding. This centralization was intended to streamline the processing of these cases, reflecting the growing complexity and volume of litigation surrounding Essure’s alleged safety issues and the harm reported by many users.
FDA Imposes Black Box Warning
On February 29, 2016, the FDA mandated a Black Box Warning for Essure, its most stringent warning. This decision followed an extensive review of numerous adverse event reports that highlighted complications like persistent pain and device migration. The Black Box Warning was designed to ensure that all potential users were fully aware of the serious risks associated with Essure, emphasizing the critical need for careful patient selection and thorough pre-use counseling.
FDA Demands Updated Labeling
Responding to the growing body of adverse reports from users and healthcare providers, the FDA required Essure’s labeling to be updated to include more detailed information about potential risks. This directive aimed to enhance the clarity of the device’s safety profile, covering complications such as chronic pain, bleeding, allergic reactions, and the potential need for surgical intervention. The updated labeling was intended to better inform patients and healthcare providers, facilitating more informed decision-making regarding its use.
Commencement of Legal Actions
In 2014, the first lawsuits were filed against Bayer, the manufacturer of Essure, marking the start of serious legal challenges to the device. Plaintiffs in these cases brought forth claims citing severe health issues such as chronic pelvic pain and device migration, which were purportedly caused by the Essure implants. These legal actions challenged Bayer’s assertions of safety and highlighted significant personal and systemic issues associated with the device.
Initial FDA Reports and Scrutiny
By 2009, the US Food and Drug Administration started to receive a significant influx of adverse reports concerning Essure. These early reports, detailing serious complaints such as persistent pain, bleeding, and unintended pregnancies, were pivotal in initiating the FDA's closer scrutiny of the device. This marked the beginning of increased regulatory oversight over Essure, laying the groundwork for subsequent actions and investigations into its safety and efficacy.
Essure is a permanent birth control device developed by Bayer, consisting of small coils inserted into the fallopian tubes. The device sparked controversy due to severe side effects, leading to numerous lawsuits. Plaintiffs claimed Essure caused complications like chronic pain and organ perforation, resulting in significant legal and regulatory challenges for Bayer.
Once touted as revolutionary, Essure is a non-surgical, permanent birth control device developed by Conceptus Inc. and later acquired by Bayer. Introduced in the early 2000s, it offered women a less invasive alternative to tubal ligation through the insertion of small coils into the fallopian tubes to prevent pregnancy.
However, the reality of Essure's impact on women's health soon diverged sharply from its promise. Over time, a significant number of users began reporting severe and debilitating side effects including chronic pelvic pain, device migration, and even perforation of internal organs.
One of the most harrowing accounts, the one of Keisha Carney, illustrates the profound personal impacts, including unexpected pregnancies and severe health complications that required major surgeries such as hysterectomies.
As the volume of complaints grew, legal actions inevitably followed. Starting around 2014, thousands of women affected by Essure began to sue Bayer, alleging that the company had failed to adequately warn them about the risks associated with the device.
Bayer defended its product by standing behind the safety and efficacy supported by their research but faced increasing pressure as lawsuits mounted and stories of suffering gained public attention.
The legal strategy of the plaintiffs evolved over time, culminating in the centralization of numerous lawsuits in California and the Eastern District of Pennsylvania, aimed at streamlining the complex litigation process. This coordinated approach helped build a more formidable case against Bayer, leading to significant legal proceedings.
The growing evidence and public outcry contributed to a shift in the narrative around Essure. The culmination of these legal battles and mounting public pressure led Bayer to announce a substantial $1.6 billion settlement in 2020 to resolve about 90% of the claims filed against it in the United States, though without admitting liability or wrongdoing.
This settlement marked a significant moment in the controversy, representing an acknowledgment of the pain and suffering endured by thousands of women.
Consult a lawyer to help you navigate the claim process and secure the compensation you deserve.
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The FDA has diligently addressed the numerous issues related to Essure products, and has continually updated the public through various communications including evaluations, safety assessments, guidances, and the dissemination of detailed spreadsheets.
The agency has also required updates on websites to clearly communicate Essure's risks to potential users. Among these efforts, two official warnings stand out:
Although Essure is no longer sold in the US, and all unused Essure implants have been returned to Bayer, as of December 31, 2019, the FDA continues to monitor its safety and effectiveness, ensuring that the health of those who have used the device is not compromised.
The Essure controversy has been a focal point in legal circles and a significant challenge for legal professionals worldwide. In the following section, we will explore the basis of the allegations raised by the plaintiffs against Bayer, as well as discuss aspects related to the defense.
The complaints in the Essure lawsuits revolve primarily around the allegations that Bayer and Conceptus have failed to disclose critical risks associated with the Essure device.
Namely, thousands of plaintiffs have reported severe complications including chronic pain, bleeding, organ damage, and migration of the device. These severe side effects have not only caused physical harm but also led to numerous additional surgeries, including some cases that necessitated hysterectomy.
Studies have corroborated the severe complications associated with the Essure device, particularly chronic pain and abnormal bleeding.
Research has shown that Essure patients report significantly higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding compared to those who underwent tubal ligation. Specifically, about 9.1% of Essure patients experienced chronic pain, and 16.3% reported abnormal bleeding, highlighting a considerable impact on quality of life compared to other sterilization methods. [1]
Furthermore, there have been findings on surgical interventions following Essure implantation, where nearly 20% of women required additional gynecologic surgeries, such as device removal or treatments for heavy bleeding, significantly higher than in non-Essure patients. These studies underline the serious and often debilitating side effects linked to the Essure device, reinforcing the concerns raised by many patients over the years. [1]
The lawsuits further allege that Bayer and Conceptus engaged in systematic underreporting of these adverse events to the FDA, thus keeping the medical community and the public unaware of the true risks associated with Essure.
This alleged failure to report has been cited as contributing to the widespread use of Essure despite its potential dangers, exacerbating the health risks to thousands of women.
The defendants in the Essure lawsuits include both Bayer AG and Conceptus Inc., the original developer of Essure. Bayer acquired Conceptus in 2013, inheriting the product and the ongoing legal responsibilities associated with it.
When the allegations emerged, the defendants relied on the defense strategy of "federal preemption," which posits that FDA approval of the device precludes conflicting state claims. By using this strategy, the defendants were able to contest the legitimacy of the lawsuits and make it challenging for plaintiffs to assert their claims and for cases against them to proceed.
However, despite this defense, some claims have been allowed to proceed, particularly those that the courts found did not seek to impose standards that would conflict with federal regulations.
This is how allegations involving deceptive marketing practices and failure to warn of potential risks were allowed to advance in court. These exceptions have provided a pathway for some plaintiffs to seek redress despite the broad protections typically afforded by federal preemption.
The Essure legal proceedings have been extensive, involving numerous lawsuits against Bayer and Conceptus for severe health issues linked to the Essure device. These proceedings culminated in a substantial settlement in 2020, reflecting the complex and contentious nature of the litigation.
Bayer's primary defense in the Essure lawsuits hinged on the legal doctrine of "federal preemption," which asserts that FDA approval of a medical device shields the manufacturer from liability under state laws.
This defense was based on the premise that federal law, which governs FDA approvals, supersedes conflicting state regulations. Bayer argued that because Essure had received FDA approval, the company was protected from claims regarding the device's safety and efficacy.
However, this defense was not universally accepted in courts; some judges allowed claims to proceed, especially those that did not seek to impose standards conflicting with federal regulations.
In 2020, Bayer reached a significant milestone by agreeing to a $1.6 billion settlement to resolve approximately 90% of the pending US Essure claims. This settlement aimed to cover all jurisdictions with substantial case volumes, without Bayer admitting any wrongdoing or liability.
The settlement reflected Bayer's strategy to mitigate the ongoing legal uncertainties and public relations challenges associated with the Essure litigation.
The amount each plaintiff received varied depending on the extent of their injuries, demonstrating Bayer's approach to resolving these cases while continuing to assert the safety and efficacy of Essure as per their official stance.
If an Essure device has negatively affected your health, you may have several different legal avenues to pursue. The following section will provide you with guidance on taking legal action and the timelines for filing a lawsuit, and ensure you can seek appropriate legal recourse for your troubles with this problematic implant.
When taking legal action against Essure, it is crucial that you understand the process thoroughly and seek the appropriate legal recourse. Not everyone may be eligible to file a lawsuit, and eligibility typically depends on having documented health issues directly linked to Essure and experiencing complications that have led to significant harm or additional medical treatments.
Here is a step-by-step overview of the entire process:
Collect all medical records related to your Essure implantation, including initial procedure details, follow-up visits, and any treatments for complications.
Compile documentation of health issues experienced post-implantation, such as chronic pain, device migration, organ perforation, and any surgeries related to Essure removal or complications.
Seek a lawyer who specializes in medical device litigation. Experienced attorneys can provide a comprehensive assessment of the case's viability and offer guidance on the best course of action.
Many law firms offer free initial consultations to evaluate potential claims. During this consultation, lawyers will review the gathered documentation and provide an initial assessment of the case.
Lawsuits against Bayer typically allege severe complications caused by Essure, such as chronic pain, device migration, and organ perforation. Plaintiffs claim that Bayer failed to adequately warn users about these risks and misrepresented the device's safety.
Your lawyer will help in preparing and filing the necessary legal documents, ensuring all procedural requirements are met.
Unfortunately, there is currently no Multidistrict Litigation (MDL) for Essure. While there were attempts to create an MDL for Essure lawsuits, these motions were withdrawn, and the cases have not been consolidated under an MDL.
Instead, many cases have been coordinated through state-level processes like the Judicial Council Coordinated Proceedings (JCCP) in California and the Eastern District of Pennsylvania where cases have been consolidated for more efficient processing.
The time limit for filing an Essure lawsuit is governed by the statute of limitations, which varies by state. Generally, plaintiffs must file within two to four years from the date they discovered or should have discovered the injury caused by Essure. For this reason, it is crucial to act promptly as missing the deadline can result in losing the right to pursue compensation.
Some states may have specific rules that extend the filing period if the injury was discovered later through the discovery rule, which allows the statute of limitations to begin when the injury was or should have been discovered.
Consulting with a legal expert early can ensure that all deadlines are met and that the case is filed within the allowable time frame. Legal firms can provide guidance on the specific statutes applicable to each case and help ensure that claims are filed correctly and timely.
Moreover, specialized legal professionals can help you gather necessary documentation, navigate complex legal procedures, assess the strength of your case, and represent you in court or settlement negotiations, maximizing your chances of receiving fair compensation.
They can also provide emotional support and advocacy, ensuring that your rights are protected throughout the legal process.
Yes, Bayer agreed to a $1.6 billion settlement in August 2020 to resolve approximately 90% of the nearly 39,000 Essure claims in the United States. This settlement provided financial relief to many affected women, although Bayer did not admit any wrongdoing as part of the agreement.
As of May 2024, Essure has not been recalled. However, Bayer voluntarily discontinued sales of the device in the US in December 2018, citing declining demand. This decision came after years of adverse event reports and increased regulatory scrutiny.
Yes, Essure can cause problems years after implantation. Complications such as chronic pain, device migration, and organ perforation have been reported long after the initial procedure. These long-term issues have led to numerous additional surgeries and severe health problems for many women around the world.
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