Essure Lawsuit
Legally ReviewedFact CheckedThis article provides general information for educational purposes only. It is not legal advice, does not create an attorney-client relationship, and should not be relied upon as a substitute for consultation with a qualified attorney. Laws vary by state, and individualized guidance is recommended.
Bayer's 2020 agreements were intended to resolve most U.S. Essure claims, and the company later reported that almost all had settled. A possible new claim depends on jurisdiction, timing, prior releases, product evidence, medical causation, and damages. FDA continues long-term monitoring, but adverse-event reports alone do not prove causation.
Key Takeaways
Bayer's August 2020 agreements were intended to resolve approximately 90% of nearly 39,000 filed and unfiled U.S. Essure claims for about $1.6 billion, without an admission of wrongdoing or liability.
Bayer's March 2025 annual report said almost all U.S. Essure claims had been settled. That company disclosure does not show that every possible individual claim is closed or that a new claimant can enter the old settlement.
The FDA's 2024 data brought the total number of Essure medical device reports received since approval to 73,678, but the agency warns that reports do not by themselves establish causation, defect, unique-patient counts, or event rates.
Essure is no longer available for new implantation in the United States. The 2018 sales discontinuation was not a recall, and FDA continues long-term postmarket monitoring for people who previously received the device.
Whether an individual may still have a claim depends on jurisdiction, timing, prior settlement participation or release, proof of the Essure device, medical causation, damages, and applicable limitation rules.
Lawsuit Updates
FDA Adds 2024 Essure Report Data
The FDA updated its Essure reporting page with medical device reports received during 2024. The agency identified 73,678 reports from approval through 2024, including 803 received in 2024, but cautioned that reports may be incomplete, unverified, duplicated, or biased and cannot alone establish causation or event rates.
Bayer Reports Almost All U.S. Claims Settled
Bayer's 2024 annual report said almost all U.S. Essure claims had been settled and recorded a remaining provision of approximately $54 million for settlements and legal fees as of December 31, 2024. This was a company financial disclosure, not a court finding or an invitation to join the earlier settlement.
Essure Lawsuit Update for October 2026
Bayer announced in August 2020 that agreements totaling approximately $1.6 billion were intended to resolve about 90% of nearly 39,000 filed and unfiled U.S. Essure claims. The company did not admit wrongdoing or liability. In its 2024 annual report, published in March 2025, Bayer said almost all U.S. Essure claims had been settled and reported a remaining provision of approximately $54 million for settlements and legal fees as of December 31, 2024.
Those disclosures show that the large 2020 resolution is mature. They do not establish that every possible individual claim is closed, that a new claimant can join the earlier agreements, or that a particular case is timely. A case-specific answer depends on the governing jurisdiction, injury and discovery dates, any prior settlement participation or release, medical and product evidence, causation, damages, and applicable limitation rules.
Can You Still File an Essure Lawsuit?
There is no nationwide yes-or-no answer. The 2020 Bayer settlement announcement concerned agreements for existing filed and unfiled U.S. claims represented by participating law firms. It was not a public, open-ended compensation program.
A lawyer evaluating a possible claim would generally need to determine:
- which state's law applies and when its filing period began;
- when the person first knew, or reasonably should have known, of the alleged injury and its possible connection to Essure;
- whether the person previously retained counsel, entered the 2020 resolution, or signed a release;
- whether implantation records identify Essure and document the procedure;
- whether medical records support the alleged injury and a causal connection; and
- what recoverable damages can be documented.
Statutes of limitation and repose differ by jurisdiction. Discovery rules, tolling doctrines, prior filings, and releases may affect the analysis. Anyone considering a claim should obtain advice about their own facts rather than relying on the date or amount of Bayer's earlier settlement.
What Essure Was and Why It Is No Longer Implanted
Essure was a permanently implanted birth-control device placed through the cervix and uterus into the fallopian tubes. The FDA approved it on November 4, 2002 and continued postmarket oversight after approval.
The agency's Essure regulatory timeline records several later actions. In October 2016, the FDA approved labeling changes that included a boxed warning and patient decision checklist. On April 9, 2018, the agency restricted sales and distribution to health care providers who agreed to review Bayer's patient-doctor discussion checklist with prospective patients and give them an opportunity to sign it before implantation.
Bayer announced in July 2018 that U.S. sales and distribution would end after December 31, 2018 for commercial reasons. The FDA says all unused units should have been returned by December 31, 2019. The discontinuation was not a recall, and Essure is no longer available for new implantation in the United States.
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Settlement Status and Compensation
Bayer's August 2020 announcement described agreements totaling approximately $1.6 billion to resolve about 90% of nearly 39,000 filed and unfiled U.S. claims. It said resolving claimants would dismiss their cases or agree not to file and that Bayer made no admission of wrongdoing or liability.
The reviewed primary sources do not publish a reliable average individual payment or an allocation formula. Dividing $1.6 billion by a headline claim count would ignore legal fees, administrative costs, differing claim circumstances, and the actual terms applicable to each claimant. That arithmetic therefore would not establish what any person received or what a different claim may be worth.
Bayer's March 2025 annual report is the most recent company disclosure reviewed for this update. It says almost all U.S. Essure claims had been settled and reports the remaining provision, but it does not create a new claims process or determine whether an unrepresented person can still sue.
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What FDA Medical Device Reports Do—and Do Not—Show
The FDA continues to monitor Essure through postmarket studies and medical device reports. Its Problems Reported with Essure page says the agency received 73,678 Essure-related medical device reports from approval on November 4, 2002 through December 31, 2024. Of those, 803 were received in 2024.
Those numbers require careful interpretation. The FDA explains that medical device reports may contain incomplete, inaccurate, untimely, unverified, duplicated, or biased information. A report does not by itself prove that a device caused an event, represent a unique patient, establish a product defect, or provide an event rate. The data are safety-monitoring signals, not findings of medical or legal causation in any individual case.
The FDA page identifies frequently reported patient problem codes over the full reporting period, including pain, heavier or irregular menstruation, foreign-body or device-fragment issues, perforation, headache, fatigue, and weight fluctuations. These are report categories, not conclusions that Essure caused every reported condition.
Symptoms, Evaluation, and Removal Questions
People have reported pain, bleeding, device fragments, perforation, migration, allergic-type reactions, and other concerns after Essure implantation. Symptoms can have more than one possible cause, so diagnosis and treatment decisions require an individualized medical evaluation.
The FDA's information for patients and health care providers says patients who have been using Essure successfully to prevent pregnancy can and should continue to do so. People who suspect device-related symptoms should consult a health care provider about appropriate next steps. The agency also cautions that removal is a surgical procedure with its own risks and that patients should discuss the benefits and risks of any operation before deciding.
This article cannot determine whether a person's symptoms are related to Essure or whether removal is medically appropriate. Medical advice should come from a qualified clinician who can review the person's history, examination, imaging, and other relevant evidence.
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Evidence to Preserve for a Case Review
A legal review is more useful when it is supported by contemporaneous records. Depending on the allegations, relevant materials may include:
Evidence category | Examples to preserve |
|---|---|
Implantation and product identification | Operative notes, implant date, facility records, product labels, lot or serial information if available |
Follow-up and confirmation | Follow-up visit notes, imaging, and any confirmation-test records |
Symptoms and treatment | Office notes, emergency visits, diagnostic testing, prescriptions, referrals, and a dated symptom history |
Device position or condition | X-rays, ultrasound or other imaging, radiology reports, and clinician assessments |
Removal or other surgery | Operative reports, pathology, photographs if part of the medical record, and postoperative notes |
Damages | Medical bills, insurance records, wage-loss documents, and other out-of-pocket costs |
Prior legal activity | Retainer agreements, filed complaints, settlement communications, releases, and dismissal papers |
Records should be preserved in their original form. A personal chronology can help organize events, but it should not replace source records or add details the writer cannot independently verify.
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When the Available Facts May Not Support a Claim
An allegation alone does not establish liability. A potential claim may face substantial problems when records do not identify Essure, medical evidence does not support the alleged injury or connection, another cause better explains the condition, recoverable damages cannot be shown, a prior release covers the dispute, or the applicable filing period has expired.
Federal preemption and other product-liability defenses can also affect claims involving an FDA-approved medical device. The available theory and required proof depend on the pleaded facts and controlling law. A lawyer would need to analyze the actual records and jurisdiction before expressing a view on viability.
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Essure Litigation and Regulatory Timeline
- March 26, 2025: The FDA updated its Essure reporting page with 2024 medical device report data. The page identifies 73,678 reports received from approval through 2024, including 803 received in 2024, while warning that the reports cannot by themselves establish causation or event rates.
- March 5, 2025: Bayer published its 2024 annual report, stating that almost all U.S. Essure claims had been settled and reporting an approximately $54 million remaining provision as of December 31, 2024.
- August 20, 2020: Bayer announced approximately $1.6 billion in agreements intended to resolve about 90% of nearly 39,000 filed and unfiled U.S. claims, without admitting wrongdoing or liability.
- July 20, 2018: Bayer announced that U.S. sales and distribution would end after December 31, 2018. The FDA later stated that unused units should have been returned by December 31, 2019.
- April 9, 2018: The FDA restricted sales and distribution to providers who reviewed the patient-doctor discussion checklist with patients and gave them an opportunity to sign it before implantation.
- October 2016: The FDA finalized labeling guidance for permanent hysteroscopically placed tubal implants, and its regulatory timeline says Essure labeling changes included a boxed warning and patient decision checklist.
- November 4, 2002: The FDA approved Essure as a permanently implanted birth-control device.
Frequently Asked Questions
Can I still file an Essure lawsuit?
Possibly, but there is no nationwide answer. Eligibility depends on jurisdiction, injury and discovery dates, any prior settlement participation or release, supporting evidence, causation, damages, and applicable limitation rules. The 2020 settlement announcement does not show that a new claimant can join that resolution.
What was the Essure settlement amount and average payout?
Bayer announced approximately $1.6 billion to resolve about 90% of nearly 39,000 filed and unfiled U.S. claims. The reviewed primary sources do not publish a reliable average individual payment or allocation method. Dividing the total by the claim count would not establish what any claimant received.
Can Essure-related problems appear years after implantation?
The FDA continues long-term monitoring and has received reports involving pain, bleeding, fragments, perforation, migration, and other problems. Reports do not by themselves prove that Essure caused a particular person's symptoms. A qualified health care professional should evaluate new or persistent symptoms.
Is Essure still available for new patients?
No. U.S. sales ended after December 31, 2018, and the FDA says unused units should have been returned by December 31, 2019.
Should Essure be removed when a patient has no symptoms?
The FDA says patients who have been using Essure successfully can and should continue to do so. Removal requires surgery and carries its own risks. A patient should discuss personal symptoms, options, and the benefits and risks of any procedure with a qualified health care provider.
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