Bayer’s $1.6 billion settlement over its Essure permanent birth control device represents one of the largest medical device settlements in recent history, and funds have been distributing to affected women who suffered serious injuries including chronic pain, device migration, organ perforation, and unintended pregnancies. The settlement, reached to resolve thousands of claims consolidated in multidistrict litigation (MDL No. 2782) in the Northern District of California, did not require Bayer to admit wrongdoing, but the sheer dollar figure reflects the severity and volume of injuries reported by women who had the nickel-titanium coils implanted.
For example, one common claimant profile involves a woman who had Essure inserted as a supposedly permanent, non-surgical sterilization method, only to require a full hysterectomy within a few years to remove the device after it broke apart or migrated into her abdominal cavity. The settlement has been resolving claims in waves rather than through a single payout, with individual compensation amounts varying significantly based on the nature and severity of each woman’s injuries. Women who underwent hysterectomies, suffered perforated organs, or experienced ectopic pregnancies generally received larger awards than those with less invasive complications, though virtually all claimants reported significant pain and suffering.
Table of Contents
- How Did the $1.6 Billion Essure MDL Settlement Come About?
- What Compensation Have Women Received From the Essure Settlement?
- Which Injuries Qualified Women for the Essure Settlement?
- How Does the Essure Settlement Claims Process Work?
- What Challenges Have Claimants Faced in the Essure Settlement?
- What Happened to Essure After It Was Pulled From the Market?
- What Is the Current Status and Outlook for Essure Litigation?
- Frequently Asked Questions
How Did the $1.6 Billion Essure MDL Settlement Come About?
The Essure device was approved by the FDA in 2002 as a revolutionary alternative to surgical tubal ligation. Rather than cutting or tying the fallopian tubes, a doctor inserted small metal coils through the cervix and into each fallopian tube, where scar tissue would supposedly form around them to block the tubes permanently. Bayer acquired Essure through its purchase of Conceptus, the original manufacturer, and marketed the device aggressively as a quick, non-surgical, hormone-free option for women who wanted permanent contraception. By the time problems became undeniable, hundreds of thousands of women in the United States had received the implant. Reports of serious adverse events mounted steadily throughout the 2010s. Women reported device breakage, migration of the coils into the uterus or abdominal cavity, nickel allergic reactions causing chronic pain, abnormal bleeding, autoimmune-like symptoms, and unintended pregnancies — some of which were ectopic and life-threatening. The FDA added a black box warning to Essure in 2016, and Bayer voluntarily pulled the device from the U.S.
Market at the end of 2018, though the company maintained that the decision was commercial rather than safety-related. Lawsuits had already been piling up, and by that point thousands of women had filed individual claims that were consolidated into the mdl before Judge Wistrich in the Northern District of California. Rather than face a series of potentially enormous jury verdicts, Bayer began negotiating settlements in tranches, committing approximately $1.6 billion to resolve the litigation, according to the company’s own financial disclosures. Compared to other major medical device settlements, the Essure resolution is notable for both its size and its structure. The pelvic mesh MDL settlements — spread across multiple manufacturers including Boston Scientific, C.R. Bard, and Ethicon — collectively exceeded $8 billion, but those involved multiple defendants and tens of thousands more plaintiffs. On a per-claimant basis, the Essure settlement has been broadly comparable, though individual payouts have varied widely depending on injury severity and the specific settlement tranche in which a claim was resolved.
What Compensation Have Women Received From the Essure Settlement?
Individual payment amounts from the Essure settlement have not been publicly disclosed in most cases, as the settlement agreements typically include confidentiality provisions. However, based on reporting from attorneys involved in the litigation and financial disclosures from Bayer, the average payout per claimant has been estimated in a wide range — from the low tens of thousands of dollars for less severe cases to six figures or more for women who suffered the most catastrophic injuries. Women who required hysterectomies or experienced organ perforation have generally been in the higher tiers, while those with chronic pain but no surgical intervention may have received less. It is important to understand that the $1.6 billion figure represents a gross settlement amount. Attorney fees, litigation costs, and administrative expenses reduce the net amount distributed to claimants.
Contingency fees in mass tort cases typically range from 25 to 40 percent, meaning a claimant whose gross award was $100,000 might receive $60,000 to $75,000 after fees and costs. Some women have expressed frustration at this gap, particularly those who felt their injuries warranted far more than what they received. However, if a woman’s injuries were primarily symptoms that are difficult to tie exclusively to Essure — such as fatigue, joint pain, or general malaise — her claim may have been valued at the lower end of the spectrum or even denied. The settlement process required documented medical evidence linking the claimed injuries to the Essure device, and women whose medical records did not clearly establish that connection faced steeper challenges. This is a meaningful limitation: many women who believe Essure harmed them may not have received compensation commensurate with their suffering simply because their particular symptoms were harder to prove through medical documentation.
Which Injuries Qualified Women for the Essure Settlement?
The Essure litigation covered a broad range of injuries, but certain categories were central to the claims. Device migration — where one or both coils moved from the fallopian tubes into the uterus, abdomen, or pelvis — was among the most common and most serious allegations. When the coils migrated, they sometimes perforated the uterus or other organs, requiring emergency surgery. For instance, court filings described cases where women discovered during unrelated medical imaging that an Essure coil had traveled entirely outside the reproductive tract and was lodged against the bowel or bladder. Unintended pregnancy was another major category. Essure was marketed as being over 99 percent effective, but post-market data revealed a higher failure rate than clinical trials had suggested.
Some of these pregnancies were ectopic, occurring in the fallopian tube rather than the uterus, which is a medical emergency that can result in internal bleeding, loss of the fallopian tube, and in rare cases, death. Women who experienced ectopic pregnancies after Essure implantation had particularly strong claims. Chronic pain and nickel hypersensitivity formed a third major category. The Essure coils contain nickel, and women with nickel allergies reported persistent pelvic pain, headaches, joint pain, rashes, and fatigue — symptoms consistent with a chronic inflammatory response. Many of these women required surgical removal of the device, often via hysterectomy because the coils had become embedded in tissue and could not be removed laparoscopically. The requirement for a hysterectomy — losing the uterus because of a device intended merely to block the fallopian tubes — was a particularly devastating outcome for many claimants, especially those who experienced premature menopause as a result.
How Does the Essure Settlement Claims Process Work?
The Essure MDL settlement has operated differently from a traditional class action. Rather than a single opt-in class, the litigation involved individual lawsuits consolidated for pretrial purposes, with settlements negotiated in groups or tranches. Women were typically represented by individual attorneys or law firms that had enrolled their cases in the MDL, and settlement offers were made on a case-by-case basis through a negotiation process between Bayer and plaintiffs’ counsel. This means there was no single claim form or website for all Essure claimants — the process was managed through each woman’s attorney. For women who settled, the process generally involved submitting medical records documenting the Essure implantation, any adverse events, subsequent surgeries, and other treatment. A claims administrator reviewed this documentation and placed each claim into a tier based on injury severity.
The tiering system meant that women with similar injuries received broadly similar offers, but there was room for individual negotiation, particularly in cases with unusual or severe facts. The tradeoff of this individualized approach, compared to a class action with a uniform payout, is that some women received significantly more while others received less — and the process took longer because each case required individual evaluation. One practical consideration is that attorney involvement was essentially mandatory. Unlike some consumer class actions where individuals can file claims directly through a website, the Essure settlement required legal representation to navigate the MDL process. Women who did not already have an attorney enrolled in the MDL faced difficulty joining later settlement rounds, particularly as Bayer signaled that it considered the litigation substantially resolved. For women who may still have viable claims, consulting with a mass tort attorney who handled Essure cases is the necessary first step, though the window for new claims has been narrowing.
What Challenges Have Claimants Faced in the Essure Settlement?
One significant challenge has been the length of time between filing a claim and receiving payment. Some women filed lawsuits as early as 2014 or 2015 and did not receive settlement funds until years later. Mass tort litigation moves slowly by nature, but the Essure MDL was further complicated by Bayer’s initial aggressive defense posture, preemption arguments (the company argued that FDA approval shielded it from state-law claims), and the sheer volume of individual cases requiring separate evaluation. For women dealing with ongoing medical expenses and lost income due to their injuries, the delay compounded their suffering. The preemption issue deserves particular attention because it affected the legal landscape significantly. Bayer argued that because Essure went through the FDA’s premarket approval (PMA) process, federal law preempted state tort claims.
The company won some early rulings on this basis, which threatened to gut the litigation entirely. However, several courts found that certain claims — particularly those alleging that Bayer failed to report adverse events to the FDA or violated federal manufacturing standards — could survive preemption. This legal back-and-forth created uncertainty for claimants and influenced settlement values, as the risk of a preemption ruling being upheld on appeal was a factor that both sides weighed. Another limitation is that the settlement does not cover long-term health monitoring or future medical expenses in most cases. Women who settled received a lump sum intended to compensate for past and future damages, but if new health problems emerge years later that are connected to the Essure device, they generally cannot seek additional compensation from Bayer under the settlement terms. This is a common tradeoff in mass tort settlements — certainty and finality versus the possibility that injuries have not fully manifested — and it is one that claimants should understand before accepting any offer.
What Happened to Essure After It Was Pulled From the Market?
Bayer stopped selling Essure in the United States at the end of 2018, and the device had already been withdrawn from most international markets by that point. The FDA did not formally recall Essure, but the agency took the unusual step of requiring a boxed warning and a patient decision checklist — restrictions that effectively made the device impractical to market. Bayer framed the withdrawal as a business decision driven by declining sales rather than safety concerns, a characterization that many patients and advocates found disingenuous given the thousands of adverse event reports the FDA had received.
For women who still have Essure coils implanted, removal remains a complicated medical decision. Not all gynecologists are experienced in Essure removal, and the procedure often requires hysterectomy rather than simple extraction, particularly if the coils have become embedded in tissue or have partially fragmented. Some specialized surgeons have developed techniques for removing the coils while preserving the uterus, but these procedures are not widely available and may not be covered by insurance. Women considering removal should seek out a surgeon with specific Essure removal experience rather than relying on a general OB-GYN.
What Is the Current Status and Outlook for Essure Litigation?
As of recent reports, Bayer has characterized the Essure litigation as substantially resolved, having settled the vast majority of pending claims. The company’s financial disclosures have reflected the $1.6 billion figure as its total expected liability for the Essure matter, though residual claims and any new filings could adjust that number. The MDL in the Northern District of California has been winding down, with the court disposing of remaining cases through settlement or individual adjudication.
For women who have not yet filed claims, the window is likely closing or may have already closed in many jurisdictions, as statutes of limitations and repose vary by state. However, some attorneys continue to evaluate potential Essure cases, particularly for women who only recently discovered the connection between their symptoms and the device — a scenario that could extend the filing deadline under the discovery rule in some states. Women who believe they were harmed by Essure and have not consulted an attorney should do so promptly, keeping in mind that there is no guarantee that new claims will be accepted into any future settlement. The broader legacy of the Essure litigation has been to reinforce scrutiny of the FDA’s premarket approval process for medical devices and to highlight the gap between clinical trial data and real-world patient outcomes.
Frequently Asked Questions
Is the Essure settlement still open for new claims?
As of recent reports, Bayer has described the litigation as substantially resolved. Most settlement rounds have closed, and new claims face statute of limitations barriers in many states. However, the discovery rule may extend deadlines for women who only recently connected their symptoms to Essure. Consulting a mass tort attorney is essential to determine whether a viable claim still exists.
How much money did individual women receive from the Essure settlement?
Individual amounts varied widely based on injury severity and were generally subject to confidentiality provisions. Reports suggest payouts ranged from the low tens of thousands for less severe injuries to six figures or more for women who required hysterectomies or suffered organ perforation. These amounts are before attorney fees and costs, which typically reduced the net payment by 25 to 40 percent.
Do I need a lawyer to participate in the Essure settlement?
Yes. Unlike some consumer class action settlements with online claim forms, the Essure MDL required legal representation. Claims were filed as individual lawsuits consolidated in the MDL, and the settlement process was managed through plaintiffs’ attorneys. Women without an attorney enrolled in the MDL could not directly file claims with a court administrator.
Can I still get my Essure device removed?
Yes, removal is still possible, but it is a significant medical procedure. Many removals require hysterectomy, though some specialized surgeons can remove the coils while preserving the uterus. Insurance coverage varies, and not all gynecologists have experience with Essure removal. Seeking a surgeon with specific Essure removal expertise is strongly recommended.
Did Bayer admit that Essure was defective?
No. The settlement, like most mass tort resolutions, included no admission of wrongdoing or liability by Bayer. The company has maintained that Essure was safe and effective when used as directed, a position that many patients and their advocates dispute. The $1.6 billion settlement figure, however, speaks to the strength of the claims Bayer faced.
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