The Essure permanent birth control system generated one of the largest medical device settlements in history: a 2020 class action settlement worth $1.6 billion to resolve approximately 39,000 claims against manufacturer Bayer. Women who experienced complications from the implanted contraceptive device—ranging from chronic pain and device migration to unintended pregnancy—received an average payout of $45,600 per person, adjusted for the severity of their injuries. This settlement resolved a decade-long legal battle between injured women and one of the world’s largest pharmaceutical companies. Essure was marketed as a permanent, non-hormonal birth control method that required a simple office procedure: two tiny metal coils were threaded into each fallopian tube to trigger the body’s natural immune response, creating scar tissue that blocked conception.
The device promised convenience and permanence—no surgery, no pills, no ongoing maintenance. Instead, thousands of women reported unexpected pregnancies, chronic pelvic pain, device fragments lodging in their organs, and severe bleeding that required emergency hysterectomies to resolve. The litigation spanning 2013 to 2020 uncovered troubling patterns in how the device was tested, marketed, and monitored for safety. By the time Bayer discontinued Essure sales on December 31, 2018, the FDA had received 72,875 adverse event reports related to the device, yet doctors and potential patients were often unaware of the risks.
Table of Contents
- How Did Essure Complications Become a Class Action Issue?
- What Safety Issues Led to the FDA Black Box Warning?
- What Did the 2020 Bayer Settlement Provide?
- Are There Still Active Essure Class Action Cases?
- What Complications Did Essure Users Experience?
- How Do Essure Claimants File Claims and Prove Eligibility?
- What Do Essure Litigation Outcomes Teach About Medical Device Safety?
How Did Essure Complications Become a Class Action Issue?
Essure received FDA approval in 2002 through an expedited clearance pathway that did not require extensive clinical trials. Women began reporting problems almost immediately—but those complaints were scattered across emergency rooms, gynecology offices, and FDA databases rather than consolidated into a coherent safety signal. A woman in Michigan might suffer device migration while a woman in Texas experienced perforation of her fallopian tube, with neither aware the other’s complication existed, let alone that thousands of others reported similar injuries.
The turning point came in 2015 when investigative journalists and patient advocacy groups began connecting the dots. That year, the american Journal of Obstetrics and Gynecology published research questioning Essure’s effectiveness and safety in real-world use—a stark contrast to Bayer’s marketing materials, which emphasized a 99% effectiveness rate. Soon after, women who had suffered Essure-related injuries began filing lawsuits, initially in state courts, then in federal multidistrict litigation. By 2016, the FDA added a black box warning to Essure, the agency’s most serious safety alert, acknowledging risks including chronic pain, unusual bleeding, perforation, and device migration.
What Safety Issues Led to the FDA Black Box Warning?
The FDA’s black box warning in 2016 formally acknowledged that Essure carried significant risks that the initial 2002 approval had not fully captured. From 2002 through 2024, the FDA documented 72,875 medical device reports—an astonishing volume that dwarfed the adverse event reporting for most other contraceptive methods. Over 6,000 of these reports involved device migration, meaning the metal coils moved from their intended position in the fallopian tubes to other locations in the pelvis, abdomen, or body. Migration sometimes caused no symptoms; in other cases, it led to perforation of internal organs, chronic inflammation, and severe pain that required surgical removal. Pregnancy-related failures represented another critical safety failure.
The FDA received 4,629 reports of pregnancies in women using Essure between 2002 and 2024. Of these, 1,079 resulted in live births and 2,346 ended in miscarriage or pregnancy loss. These numbers directly contradicted Bayer’s “99% effective” marketing claim and raised urgent questions about informed consent: if nearly 4,600 women became pregnant despite using permanent birth control, why were potential patients not informed of this real-world failure rate? A woman who conceived after Essure implantation faced not only the shock of an unplanned pregnancy but also serious questions about fetal safety when exposed to the device and its materials during gestation. The limitations of post-approval safety monitoring became evident in the Essure case. The FDA relies partly on voluntary adverse event reporting, and many women who experienced Essure complications may not have connected their symptoms to the device or may have been discouraged from reporting by their doctors. Additionally, Bayer had minimal financial incentive to aggressively investigate safety signals—a reality that underlies why FDA oversight and plaintiff-driven litigation often uncover harms that manufacturers’ internal processes miss.
What Did the 2020 Bayer Settlement Provide?
The $1.6 billion settlement, finalized in 2020, created a compensation fund for approximately 39,000 women and their dependents who claimed Essure-related injuries. To be eligible, claimants had to demonstrate that they were implanted with Essure, experienced one or more covered injuries, and pursued claims within specified deadlines. The average award of $45,600 per person was not distributed equally; instead, awards were calibrated by injury severity, with women who underwent hysterectomy, experienced multiple complications, or suffered severe chronic pain receiving substantially higher payouts. The settlement was structured in tiers. The highest tier, reserved for women who underwent hysterectomy or had the most severe documented injuries, could yield payouts of $400,000 or more.
Mid-tier claimants—those with significant but less severe complications—received awards in the $50,000 to $150,000 range. Lower-tier claimants, who experienced pain or bleeding but no major surgical intervention, typically received $10,000 to $50,000. One important limitation: Bayer made no admission of guilt or wrongdoing in the settlement agreement, a standard negotiating position in mass tort settlements that sometimes frustrates plaintiffs seeking acknowledgment of harm. The settlement process required women to submit detailed documentation of their Essure implantation, medical records showing complications, and supporting physician statements. Claims administrators reviewed submissions and assigned injury tier ratings; claimants who disagreed with their rating could request review. By 2024, the vast majority of eligible claims had been processed and paid, though some disputes over rating determinations continued through appeals processes.
Are There Still Active Essure Class Action Cases?
As of early 2025, most Essure litigation had concluded, but a handful of cases remained active in state courts, particularly in California and Pennsylvania. These lingering cases typically involved claimants who either missed the settlement claim deadline or had unique circumstances that distinguished their injury from the settled claims. Additionally, a few cases involved specific defective batches of Essure or alleged failures by healthcare providers during implantation, which sometimes fall outside the parameters of the primary mass tort settlement.
In February 2025, several cases that had been stayed (temporarily paused) to allow for settlement negotiations were expected to resume proceedings or be resolved through individual settlements. The pace of resolution in these remaining cases is considerably slower than the mass settlement process was, partly because each case may involve unique facts and partly because the settlement defendant pool is now depleted for most claimants. Any woman considering whether she has grounds for an Essure claim should consult an attorney immediately, as statutes of limitation may have passed in her jurisdiction and claim deadlines may be approaching.
What Complications Did Essure Users Experience?
The documented complications from Essure ranged from mildly inconvenient to life-altering. Chronic pelvic pain was the most frequently reported injury—pain that persisted for months or years after implantation and often did not resolve even after device removal. Some women described the pain as continuous aching; others reported sharp, unpredictable episodes that interfered with work, intimacy, and daily activities. This pain had no cure other than device removal and sometimes hysterectomy, yet some women were not informed that Essure might cause it, and some doctors initially attributed their pain to unrelated causes. Abnormal bleeding occurred in thousands of cases, ranging from slightly heavier periods to severe, uncontrolled bleeding that required repeated emergency room visits. Perforation—when the device punctured through the fallopian tube or uterus—sometimes occurred immediately after implantation and sometimes developed gradually over years.
Women reported device migration into the abdominal cavity, pelvis, bladder, and even rare cases where fragments of the coil lodged near major blood vessels. Hypersensitivity reactions and chronic inflammation also occurred, likely due to the device’s nickel content triggering immune responses in some women. One 2018 case study, published after litigation intensified, described a woman who underwent Essure implantation in 2007 and experienced progressive pelvic pain starting in 2010. Her pain gradually worsened despite repeated visits to multiple doctors, each of whom attributed the pain to unrelated gynecological or musculoskeletal issues. By 2015, she underwent extensive surgery to remove the Essure device from her fallopian tube, which had adhered to surrounding tissue, necessitating a partial hysterectomy. The removal surgery itself caused complications, and her recovery took months. She eventually received a settlement award, but years of suffering preceded that resolution—a timeline that illustrates why early recognition and aggressive safety monitoring matter so profoundly.
How Do Essure Claimants File Claims and Prove Eligibility?
To file an Essure claim during the active settlement period, women had to work through the settlement administrator (hired by the court to manage claims processing) and provide compelling evidence of their Essure implantation and injury. The required documentation typically included the date and location of implantation, operative notes from the implanting physician, medical records documenting post-implantation complications, imaging studies (ultrasound, CT scans, etc.), and statements from treating physicians confirming causation—that is, confirming the physician believed the complications were caused by or significantly worsened by the Essure device. The injury rating process was critical to the claim outcome because it determined the payout tier. Claimants with minimal documentation sometimes received lower tier ratings, even if their injuries were severe, because the administrator could not definitively establish causation.
Conversely, claimants with comprehensive medical records and strong physician support could move into higher tiers and receive payouts of $200,000 or more. An important comparison: women who had hysterectomy records explicitly documenting Essure removal as the reason for surgery moved through the process relatively quickly, while women with chronic pain but no surgical intervention faced more scrutiny regarding whether Essure was truly the causative agent. For women who believe they had Essure implantation but lack medical records, the process becomes more complex. They may need to obtain records from the implanting physician, often many years after the procedure, or provide other corroborating evidence such as insurance claims or pharmacy records related to pain management medications filled after implantation. Some settlement claims were initially denied due to insufficient documentation, though claimants could appeal and sometimes obtain additional records to support their claim.
What Do Essure Litigation Outcomes Teach About Medical Device Safety?
The Essure case exposed significant gaps in how the FDA approves and monitors medical devices. The 2002 approval was granted through the 510(k) pathway, which allows manufacturers to avoid rigorous clinical trials if their device is “substantially equivalent” to an already-approved predicate device. Essure was compared to other intrauterine devices (IUDs), but the comparison was imperfect because Essure worked through a different mechanism and involved a different anatomical location. Subsequent research revealed that the real-world performance of Essure—particularly its effectiveness and complication rates—differed substantially from what was presented to the FDA during the approval process. The Essure litigation also highlighted the limitations of passive safety monitoring.
The FDA depends partly on voluntary reports from manufacturers and healthcare providers, supplemented by consumer complaints through MedWatch. This passive system can identify trends in highly conspicuous injuries but often misses complications that patients and doctors attribute to other causes. A woman experiencing pelvic pain years after Essure implantation might not immediately connect the symptom to the device, and her doctor might not suggest the connection. Only when enough cases aggregated—through patient advocacy groups and eventual legal proceedings—did the pattern become undeniable. In recent years, the FDA has invested in more active surveillance for devices, including systematic review of medical claims databases, in an effort to catch safety problems earlier.
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