2018 Essure Lawsuit News: In April 2018, the U.S. Food and Drug Administration (FDA) issued tighter regulations on Essure birth control devices, citing complication risks. If you have suffered from a severe side effect of an Essure implant, talk to a birth control lawyer now to see if you are eligible for compensation.
Essure is a birth control device created by the medical device company Conceptus Inc., which was later bought by the international pharmaceutical and medical device company Bayer HealthCare. Marketed by Bayer as an effective, non-surgical medical device to prevent unwanted births, Essure has since become the subject of more than 16,000 lawsuits from women who have experienced severe complications after receiving the device.
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Essure Problems, Complications and Side Effects
Essure consists of two small metal coils that, when implanted, block eggs from moving through the fallopian tubes, thus preventing fertilization and implantation. It is technically a form of tubal ligation, although it does not consist of “tying” the fallopian tubes, as with traditional ligation procedures.
Medical device maker Bayer markets Essure as a “permanent birth control device,” and claims that it requires only a minimally invasive procedure that can be done right in a doctor’s office. However, those who receive Essure must continue using other forms of birth control for at least three months after insertion to confirm that it is working.
Unfortunately, a lot of people have experienced severe side effects and complications from Essure after implantation. These problems including everything from pelvic pain 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 and allergic reactions
- Hair loss
- Brain fog
- Rashes or itching
- Severe or chronic pain
- Unintended or unwanted pregnancy
- Weight fluctuations
- Ectopic pregnancy
- Fetal death
- Device breakage, migration or expulsion
- Perforation of the uterus, colon or another organ
- Migraine headaches
- Menstruation problems
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 successful removal of the Essure device and restoration of fertility, the procedure is still untested in a reliable clinical trial or other scientifically verifiable method.
In cases where women have experienced severe side effects, Essure coils can be removed surgically, though the contraceptive effects are not guaranteed to be reversed. Additional surgeries may be required, especially if the device breaks apart or perforates an organ.
Why Are Women Filing Essure Lawsuits?
Women are suing Bayer due to the many complications they have experienced after receiving an Essure sterilization device. Complaints range from problems caused by broken devices, device migration, and even expulsion of the birth control 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.
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FDA Adverse Events and Actions
The FDA originally approved Essure as a Class III medical device in 2002. After the initial approval, 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:
- June 2008: The FDA notified Bayer that it discovered the company had been making Essure implants in an unlicensed factory since at least 2005, and that the company had failed to document their procedures appropriately.
- January 2011: Bayer was cited by the FDA for using unapproved materials in the Essure device, in violation of the premarket approval, which required the company to seek additional approval for any design changes.
- 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: The FDA restricted sales of Essure to doctors and medical centers that promised to conduct a conversation and go through a checklist with the patient before prescribing Essure.
Will Preemption Laws Stop Essure Lawsuits?
Bayer has tried to get many Essure lawsuits dismissed because of certain laws known as preemption laws. According to the corporation, because the FDA puts medical devices through a rigorous series of tests before approving them, the company cannot be held liable for problems with Essure, which has been deemed to be generally safe by the regulatory agency.
This argument is problematic on a number of levels, especially since it’s clear that Bayer did not always follow its postmarket regulatory obligations, as outlined above. Nonetheless, the medical device manufacturer has been successful in getting some product liability lawsuits dismissed using this argument, while others have been allowed to move forward, often with modified complaints.
If you’re unsure whether your experience with Essure is eligible for compensation, you can talk to a lawyer for a free case review to learn more about your legal rights and the likelihood of success.
Essure Litigation in Progress
According to Bayer’s most recent financial reports, there are approximately 16,100 lawsuits in both federal and state courts across the United States. At this time, these lawsuits are all individual legal actions; there is 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 Ensure 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 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.
Can I File an Essure Lawsuit?
You or a loved one may be able to file an Ensure 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.
To learn more about your legal rights, talk to an Essure lawyer today.
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