The Essure permanent birth control lawsuit saga reached its most significant milestone in August 2020, when Bayer agreed to pay $1.6 billion to settle approximately 39,000 claims filed by women who suffered serious injuries from the implantable contraceptive device. That settlement covered roughly 90% of the lawsuits pending at the time, with individual payouts averaging around $45,600, though amounts varied widely depending on the severity of each woman’s injuries. Bayer admitted no wrongdoing or liability as part of the deal. For a woman like Frankie Baca, who filed her lawsuit in June 2023 — years after the main settlement — the legal fight is far from over.
As of early 2026, no major new settlement announcements have been made since that 2020 resolution, but the Essure litigation remains active on multiple fronts. New individual cases continue to be filed in the United States, particularly by women who were not part of the original settlement. Meanwhile, international lawsuits in the United Kingdom, Australia, and the Netherlands are pushing forward with thousands of additional plaintiffs. This article covers the full timeline of Essure’s rise and fall, the scope of injuries reported to the FDA, the ongoing legal battles in U.S. courts, the expanding international litigation, and what options remain for women still dealing with the consequences of this device.
Table of Contents
- What Happened With the Essure Permanent Birth Control Lawsuits and How Much Did Victims Receive?
- FDA Adverse Event Reports Reveal the True Scale of Essure Injuries
- Federal Preemption — The Legal Obstacle That Has Divided Courts
- International Essure Lawsuits Are Expanding Across Three Continents
- Can You Still File an Essure Lawsuit in the United States?
- What the Essure Case Reveals About FDA Medical Device Oversight
- Where Essure Litigation Stands Heading Into 2026 and Beyond
- Conclusion
- Frequently Asked Questions
What Happened With the Essure Permanent Birth Control Lawsuits and How Much Did Victims Receive?
Essure was FDA-approved in 2002, originally manufactured by Conceptus Inc. before Bayer acquired the company. The device consisted of small metal coils inserted into the fallopian tubes, where scar tissue would form to block the tubes and prevent pregnancy. It was marketed as a less invasive alternative to surgical tubal ligation — no incisions, no general anesthesia, and a procedure that could be done in a doctor’s office. For years, it seemed like a breakthrough. But thousands of women began reporting severe complications: chronic pain, heavy bleeding, device migration, nickel allergic reactions, and unintended pregnancies. Some women required major surgery, including hysterectomies, to have the device removed. The legal response was massive.
Lawsuits consolidated in the California Joint Council Coordinated Proceedings and the Federal District Court for the Eastern District of Pennsylvania. By the time Bayer announced the $1.6 billion settlement in August 2020, the company was facing a legal crisis comparable to its Roundup litigation. The settlement resolved claims from tens of thousands of women, but the payout structure meant that women with the most severe injuries — those who needed hysterectomies, suffered ectopic pregnancies, or endured years of debilitating pain — received significantly more than the $45,600 average. Women with less severe documented injuries received less. Bayer framed the settlement as a business decision to eliminate uncertainty, not an admission that the device was defective. Bayer stopped selling Essure in the United States in December 2018, and by December 31, 2019, all unused units were to be returned to the company. The device is no longer available for implantation anywhere. But the health consequences for women who had Essure implanted continue, and so does the litigation for those who missed the initial settlement window or whose injuries were not yet fully understood at the time.
FDA Adverse Event Reports Reveal the True Scale of Essure Injuries
The FDA’s adverse event database tells a staggering story about Essure’s safety record. From November 4, 2002 through December 31, 2024, the agency received 73,678 medical device reports related to the device. Of the 57,802 reportable events submitted, 57,099 were classified as serious injuries, 588 were malfunctions, and 115 were deaths. Those numbers make Essure one of the most heavily reported medical devices in FDA history. Perhaps most damning for a device marketed as permanent birth control: the FDA received 4,629 pregnancy reports from women who had Essure implanted. Of those pregnancies, 2,346 ended in pregnancy loss and 601 were ectopic pregnancies — a life-threatening condition where a fertilized egg implants outside the uterus. Pain and hemorrhage were the most frequently reported adverse events overall.
The device removal rate was 20.9% for U.S. patients and 17.6% for international patients, meaning roughly one in five American women who received Essure eventually had it taken out. However, these FDA numbers come with an important caveat. Adverse event reporting is voluntary for patients and healthcare providers, which means the actual number of women harmed by Essure is almost certainly higher than what the database reflects. Many women may not have connected their symptoms to the device, particularly in the early years before widespread media coverage of Essure problems. Others may have had their devices removed without filing a formal report. The FDA data represents the floor of Essure injuries, not the ceiling, and lawyers pursuing remaining cases continue to use this data as foundational evidence.
Federal Preemption — The Legal Obstacle That Has Divided Courts
The most contentious legal issue in Essure litigation has nothing to do with whether the device caused harm. It is whether women are legally allowed to sue Bayer at all. Because Essure went through the FDA’s rigorous Pre-Market Approval process, Bayer has argued that federal law preempts state-law claims — essentially that FDA approval shields the company from lawsuits alleging the device was defective or that Bayer failed to warn patients about risks. This argument draws on the Supreme Court’s 2008 decision in Riegel v. Medtronic, which held that FDA-approved devices carry a degree of legal protection against state tort claims. Courts have reached split rulings on this question. In California, an Alameda County judge ruled that a narrowed set of claims from 14 women could proceed, finding that certain allegations — such as manufacturing defects or violations of FDA requirements — were not preempted by federal law. But a different California judge dismissed a separate case entirely on preemption grounds.
This inconsistency means that the viability of an Essure lawsuit can depend heavily on which court hears it, which specific claims are alleged, and how a judge interprets the boundaries of federal preemption. For women considering filing a new Essure lawsuit, this legal landscape creates real uncertainty. A case built around allegations that Bayer violated FDA-imposed requirements or manufactured defective units may survive preemption challenges, while broader claims about design defects or inadequate warnings may not. The case of Frankie Baca et al. v. Bayer, filed in June 2023 in the Eastern District of Pennsylvania as Case No. 2:23-cv-02280, demonstrates that plaintiffs’ attorneys are still finding ways to frame viable claims. But any woman exploring legal action should understand that preemption remains the single biggest hurdle in Essure litigation.
International Essure Lawsuits Are Expanding Across Three Continents
While U.S. litigation has largely been resolved through the 2020 settlement, international lawsuits against Bayer are gaining significant momentum. In September 2023, the English High Court approved a Group Litigation Order allowing approximately 200 women to collectively sue Bayer under the Consumer Protection Act and negligence theories. Bayer sold Essure in the United Kingdom between 2009 and 2017, and the women bringing claims allege injuries similar to those reported by American plaintiffs — chronic pain, device fragmentation, unintended pregnancies, and the need for surgical removal. Potential damages in the UK case could exceed £10 million, roughly $12 million. The UK litigation operates under a fundamentally different legal framework than U.S. cases.
There is no federal preemption defense in British law, which removes the most formidable obstacle that American plaintiffs face. Consumer protection statutes in the UK impose strict liability for defective products, meaning plaintiffs may not need to prove Bayer was negligent — only that the product was defective and caused harm. This is a significant advantage for claimants. Bayer has vowed to defend itself “vigorously” against the UK claims, but the legal terrain is less favorable for the company than in the United States. Beyond the UK, additional international lawsuits are pending in Australia with approximately 1,700 plaintiffs and in the Netherlands with roughly 1,000 plaintiffs. These cases represent a second wave of Essure accountability that could result in additional payouts from Bayer, even years after the company thought it had contained the litigation. For women in these countries, the international cases offer a path to compensation that U.S. courts have largely closed — though the tradeoff is that international litigation often moves slower and outcomes remain uncertain.
Can You Still File an Essure Lawsuit in the United States?
New Essure lawsuits can still be filed in the United States, but the path is considerably narrower than it was before the 2020 settlement. Women who were part of the original settlement and accepted payouts generally signed releases waiving future claims against Bayer. However, women who did not participate in that settlement — whether because they were unaware of it, had not yet been diagnosed with Essure-related injuries, or simply chose not to join — may still have viable claims. The statute of limitations is a critical factor. Most states have a two- to three-year window for filing personal injury claims, typically starting from the date the injury was discovered or should have been discovered. For Essure cases, this discovery rule can be complex.
A woman who had her device implanted in 2010 but did not connect her chronic pain to Essure until 2024 might still fall within the limitations period, depending on her state’s laws. However, the longer the gap between device implantation and lawsuit filing, the harder it becomes to establish timely discovery. There is also a practical limitation that prospective plaintiffs should understand. With Bayer having already paid $1.6 billion and the device off the market since 2018, the company’s litigation posture has hardened. New individual cases will not benefit from the pressure of mass litigation, and Bayer has demonstrated a willingness to fight preemption arguments aggressively. Any woman considering a new Essure claim should consult an attorney experienced in medical device litigation who can evaluate whether her specific circumstances, injuries, and state laws support a viable case — rather than assuming a lawsuit will lead to a payout similar to the 2020 settlement averages.
What the Essure Case Reveals About FDA Medical Device Oversight
The Essure saga has become a case study in the limitations of the FDA’s Pre-Market Approval process. The device cleared the FDA’s most rigorous review pathway in 2002, which is supposed to ensure that approved devices are safe and effective. Yet within years, thousands of adverse event reports were flooding the agency. It took until 2016 for the FDA to add a black box warning to Essure — the agency’s strongest warning short of a recall — and until 2018 for the device to be pulled from the market.
During those 16 years, an estimated 750,000 women had the device implanted. This timeline has fueled broader criticism of how the FDA monitors medical devices after approval. Post-market surveillance relies heavily on voluntary reporting, which the Essure experience suggests dramatically undercounts actual injuries. Congressional hearings featuring Essure patients helped push the FDA to strengthen its oversight protocols, but the fundamental tension remains: the same approval process that created the preemption defense shielding Bayer from lawsuits was the process that allowed a device with this safety profile to remain on the market for over a decade.
Where Essure Litigation Stands Heading Into 2026 and Beyond
As of early 2026, the Essure legal landscape is defined by two parallel tracks. In the United States, the bulk of litigation is resolved, with the $1.6 billion settlement having addressed the vast majority of claims. Straggling individual cases continue to work through federal and state courts, but no mass settlement negotiations are underway and none appear imminent. The preemption question remains unresolved at the appellate level, leaving a patchwork of contradictory rulings that could eventually require Supreme Court clarification.
Internationally, the story is different. The UK Group Litigation Order, the Australian class action with 1,700 plaintiffs, and the Dutch proceedings with 1,000 plaintiffs represent a substantial ongoing liability for Bayer. These cases are still in relatively early stages, and outcomes could take years to materialize. But they also represent the possibility of new legal precedents in jurisdictions without the federal preemption shield. For the tens of thousands of women affected by Essure worldwide, the litigation may be winding down in America, but it is very much alive elsewhere — and the final chapter of Bayer’s Essure liability has not yet been written.
Conclusion
The Essure permanent birth control lawsuit represents one of the largest medical device litigation events in history, culminating in Bayer’s $1.6 billion settlement covering approximately 39,000 U.S. claims. The FDA’s adverse event data — 73,678 reports including over 57,000 serious injuries, 115 deaths, and thousands of unintended pregnancies — underscores the severity of harm that women experienced. While that 2020 settlement resolved the majority of American cases, the legal fight continues through new individual lawsuits in the U.S.
and expanding group litigation in the United Kingdom, Australia, and the Netherlands. For women still affected by Essure, the practical takeaway is this: options still exist, but they are narrowing in the United States and depend heavily on individual circumstances, state laws, and the unresolved preemption question. International plaintiffs may face a more favorable legal environment but longer timelines. Anyone considering legal action should seek counsel from attorneys with specific medical device litigation experience who can evaluate the merits of their case against current legal realities. The Essure story is a reminder that even FDA-approved devices can cause widespread harm — and that the legal system’s response, while substantial, rarely moves fast enough for the people who need it most.
Frequently Asked Questions
How much money did Essure lawsuit victims receive on average?
The average individual payout from the 2020 Bayer settlement was approximately $45,600, but amounts varied significantly based on the severity of injuries. Women who required hysterectomies or suffered ectopic pregnancies generally received more than those with less severe complications. Bayer admitted no wrongdoing as part of the $1.6 billion settlement.
Can I still file an Essure lawsuit in 2026?
Yes, new individual lawsuits can still be filed, particularly by women who were not part of the original 2020 settlement. However, statute of limitations rules vary by state, and federal preemption remains a significant legal obstacle. Consulting with an attorney experienced in medical device litigation is essential to determine whether your case is viable.
What injuries did Essure cause?
The most commonly reported injuries include chronic pain, hemorrhage, device migration or fragmentation, nickel allergic reactions, and unintended pregnancies including ectopic pregnancies. The FDA received 57,099 serious injury reports, 4,629 pregnancy reports, and 115 death reports related to the device through December 2024. Approximately one in five U.S. patients had the device removed.
Is Essure still available?
No. Bayer stopped selling Essure in the United States in December 2018, and all unused units were to be returned to the company by December 31, 2019. The device is no longer available for implantation anywhere in the world. In the UK, Bayer sold the device between 2009 and 2017 before discontinuing it.
What is happening with Essure lawsuits outside the United States?
International litigation is active and expanding. In September 2023, a UK court approved a Group Litigation Order allowing approximately 200 women to sue Bayer, with potential damages exceeding £10 million. Australia has roughly 1,700 plaintiffs and the Netherlands has approximately 1,000 plaintiffs in pending cases. These international cases are not subject to the federal preemption defense that has limited U.S. lawsuits.
What is federal preemption and why does it matter for Essure cases?
Federal preemption is a legal doctrine arguing that because Essure went through the FDA’s Pre-Market Approval process, federal law prevents state-law claims against the device. Courts have issued split rulings on this question — some allowing narrowed claims to proceed, others dismissing cases entirely. It remains the single biggest legal obstacle for new Essure lawsuits in the United States.