Essure lawsuits claim Bayer failed to warn patients of severe device side effects. Users suffered uterus perforation, device breakage, autoimmune disorders and fetal death. At least 39,000 Essure lawsuits have been filed. No settlements have been made.
Why Are Women Filing Essure Lawsuits?
We are helping women sue Bayer after experiencing complications with the company's Essure sterilization device. Complaints range from problems caused by broken devices, device migration, and even expulsion of the contraceptive implant in some cases.
As part of the complaint, many women are seeking damages for the costs of medical care to treat symptoms and complications of the device's malfunction, along with related expenses. Many women also are seeking non-economic damages related to pain and suffering, including mental and emotional anguish, as well as punitive damages to punish Bayer for developing, manufacturing, and promoting an unsafe medical device.
FDA Adverse Events and Actions
The U.S. Food and Drug Administration (FDA) originally approved Essure as a Class III medical device in 2002. After the initial approval, Conceptus Inc. (later acquired by Bayer) was required to submit regular reports related to the device's efficacy and safety, as well as any reports of adverse events. Despite these requirements, the company was cited a number of times by the FDA for violations of those conditions, some of which resulted in future actions by the regulatory agency.
- February 2016: The FDA ordered Bayer to conduct a new clinical trial to determine whether there are any heightened risks of Essure for certain women, based on adverse event reports filed to the agency.
- November 2016: The FDA required a black box warning be added to Essure device labels indicating the risks of perforation, abdominal pain, and allergy, among other potential complications.
- April 2018: More than 26,700 complaints about Essure were filed with the FDA from late 2002 through late 2017. As a result, the FDA restricted sales of the device in April 2018.
- December 2018: The FDA approved a revised post-market surveillance plan for Essure. The new plan extended the follow-up period. It was created in response to Bayer's decision to halt sales of the Essure device by the end of 2019.
- April 2020: The FDA granted Bayer's request to deviate from certain reporting requirements.
Can Essure Be Removed or Reversed?
The Essure procedure is permanent and generally cannot be reversed, according to the birth control device's label. While there are some claims about the successful removal of the Essure device and restoration of fertility, the procedure is still untested in a reliable randomized clinical trial or another scientifically verifiable method.
In cases where women have experienced severe side effects, Essure coils can be removed surgically, though the effects of the contraceptive device are unlikely to be reversed. Additional surgeries may be required, especially if the device breaks apart or perforates an organ, or if scar tissue forms.
Unfortunately, a lot of people have experienced severe side effects and complications from Essure after implantation. Essure problems include everything from pelvic pain and allergic reactions to a need for additional surgeries to remove the device or repair organs damaged by the birth control implant.
Most Common Essure Complications and Side Effects
- Additional surgeries
- Autoimmune disorders
- Metal allergies
- Chronic fatigue
- Hair loss
- Rashes or itching
- Severe or chronic pain
- Unintended or unwanted pregnancy
- Weight gain
- Ectopic pregnancy
- Fetal death
- Device breakage, migration or expulsion
- Perforation of the uterus, colon or another organ
- Scar tissue
- Back pain
- Migraine headaches
- Menstruation problems
As of December 2019, the Essure birth control device is no longer available in the United States. Interim results from the post-market surveillance study should be posted in July 2020. Additional Essure news can be found by clicking the appropriate link below.
Current and Recent Essure Litigation
According to Bayer's most recent financial reports, there are approximately 33,000 lawsuits in both federal and state courts across the United States. At this time, these lawsuits are all individual legal actions; there are currently no Essure class action lawsuit or any multidistrict litigation (MDL) processes established.
Essure Multidistrict Litigation (MDL 2739)
In 2016, a group of 28 plaintiffs had submitted a petition to transfer their cases using the MDL process overseen by the Judicial Panel on Multidistrict Litigation. However, shortly after the petition was filed, a judge in the Eastern District of Pennsylvania - where 23 of the 28 cases had been filed - agreed to consolidate the cases in that court. The motion for an MDL was withdrawn, and the cases remained separate.
Some states, such as California, have established processes to coordinate Essure cases using processes similar to the MDL system. However, as of early 2018, no further efforts have been made to create a federal MDL for Essure lawsuits. Given the increasing number of actions being filed, it is possible that an MDL could be created in the future.
Essure Settlements and Verdicts
To date, there have been no major publicized Essure settlements or verdicts awarding large amounts of compensation to women injured by the birth control devices. However, with so many lawsuits currently going through the court system, Bayer could decide to try to settle them, if it looks like the company is likely to lose cases based on the legal merits of the claims.
In recent years, some outlets have reported that Bayer lost $413 million due to legal problems with Essure. This estimation comes from the company's financial records, which claimed €391 million in "impairment losses" related to "intangible assets" connected to Essure. The most recent annual report does not list impairment losses individually for Essure, but does note that the company incurred €258 million (about $308 million) in "expenses related to significant legal risks" for Essure, Xarelto, Cipro and Avelox.
Losses noted on corporate financial statements should not be confused with compensation paid to women harmed by Essure. It is clear, based on the amount of money the company is willing to spend defending itself against personal injury claims, that Bayer thinks losing such cases could result in much higher awards for victims of the defective devices.
Essure Lawsuit FAQs
Am I Eligible to File an Essure Lawsuit?
You or a loved one may be able to file an Essure lawsuit against Bayer if all of the following conditions are true:
- An Essure birth control device was implanted
- The device caused a severe complication, such as persistent pain, perforated organs, or another drastic side effect.
How Much Is an Essure Verdict Worth?
The exact amount of compensation you or a loved one could receive as part of an Essure settlement or favorable verdict depends on a number of factors:
- Duration and severity of the Essure side effects suffered by the patient
- Cost of treating side effects, including surgical removal of the tubal ligation device
- Follow-up care, including prescription medications to treat pain and other symptoms
- Lost income due to temporary or permanent disability caused by the device
Other economic and non-economic damages could be awarded as part of a verdict if the case goes to full trial. Settlements for Essure lawsuits would also likely take into account some or all of these factors.
What Does It Cost to Hire an Essure Attorney?
Essure lawsuits are accepted on contingency, which means you will not need to pay anything upfront. You will only be required to pay if your case is successful and you receive compensation from a verdict or settlement.