Essure, a permanent birth control device, faced significant scrutiny due to reports of serious health complications from many women who've had the device implanted. This led to various legal actions, with women seeking justice for the adverse effects they experienced.
If you're impacted, seeking the Essure lawyers with experience in medical device litigation would be wise. They can assess your situation and guide you on the best course of action tailored to your specific case. Many offer free consultations to discuss your options without any initial commitment.
What is Essure?
Essure is a form of permanent birth control that was designed to be a non-surgical alternative to tubal ligation. It involves placing small coils into the fallopian tubes. Over time, scar tissue forms around these coils, blocking the tubes and thus preventing pregnancy.
Essure was developed by a company called Conceptus Inc., which was later acquired by Bayer in 2013. Bayer took on the responsibility for the device from then on.
Essure was primarily the device behind these complications. It was, in essence, a one-of-a-kind product as there were no direct competitors producing similar permanent birth control devices using the same method.
Is Essure Still on the Market?
As of December 31, 2018, Bayer stopped selling Essure in the U.S. It is no longer available for new patients. However, those who already had the device may still be affected and require monitoring or removal.
Reported Complications
While it sounded innovative in theory, the reality for many women has been far from smooth sailing. Reported complications include:
Legal Angle: Can a Lawyer Help?
Given the severity and variety of issues associated with Essure, legal avenues have been pursued by numerous women.
A seasoned attorney can be instrumental in navigating these waters.
Navigating this situation with the Essure lawyer would mean staying calm under pressure and using the power of negotiation and comprehensive legal strategy to ensure justice. While the path may be complex, there’s always an opportunity for recourse.
FDA Involvement
Approval and Oversight
Essure was approved by the FDA in 2002 as a Class III medical device, which is the highest risk category. This classification means more stringent controls are in place before such devices are approved.
Initially, Essure seemed promising, but over time, the FDA started receiving numerous reports of adverse events. This prompted them to take a closer look.
Actions Taken by the FDA
The FDA held a public advisory meeting to gather more information regarding the complications from Essure.
They mandated a black box warning (the strictest warning for prescriptions) and issued a patient decision checklist to ensure women were fully aware of the potential risks.
Bayer announced they would discontinue sales of Essure in the U.S. by the end of the year, primarily due to declining sales and reportedly not due to safety or efficacy concerns.
The FDA continues to monitor long-term risks associated with devices already implanted, requiring Bayer to complete a post-market surveillance study following women who have the device for up to five years. Essure had a unique position in terms of method and competition, and its story is an example of the importance of ongoing vigilance even after a product hits the market.
Legal Actions and Outcomes
Class Action Lawsuits
This is when a group of people collectively bring a case against a defendant—in this instance, the manufacturer of Essure. The primary advantage of a class action is that it consolidates many similar individual claims into one larger case, which can be more efficient and cost-effective. If successful, any settlement or judgment is typically shared among the plaintiffs. However, individual stories may get less spotlight in the class action format.
Individual Lawsuit
Here, an individual woman files her lawsuit independently. The upside is that she can present her unique circumstances and potentially receive a settlement more closely aligned with her specific damages. However, this route often involves more legal expenses and time in court, and there's a risk of facing a powerful corporation alone.
You might wonder which approach has been more successful in the context of Essure—it's a mixed bag. Some women have seen significant personal settlements, while the larger class action settlements have also resolved issues for many others, albeit with varying satisfaction levels.
Manufacturer's Response
Regarding the manufacturer's response, while public statements often express concern and a commitment to resolving issues, real outcomes depend heavily on legal proceedings and settlements. Companies may deny wrongdoing as part of their strategy while simultaneously settling claims to move forward.
FAQ: Are there support groups for women affected by Essure?
Remember, you're not alone in this. Support groups and online communities can offer solidarity and advice from others who've walked a similar path. Lean on these resources when needed—there's strength in numbers, even outside the courtroom.
Guidance for Affected Women
First Steps: Recognize and Document Symptoms
The first step in this journey is to clearly recognize and document any symptoms or issues that may be related to the Essure coils. This includes physical pain, abnormal bleeding, or any unexpected changes in health.
Keep a detailed journal of your symptoms, noting when they started and how they've progressed over time. This record can be an essential piece of evidence later on.
Consulting Medical Professionals
Consulting a medical professional should be high on your list. Seek advice from a doctor who is informed about the potential complications of Essure. They can help assess whether your symptoms might be linked to the device.
Diagnostic tests or imaging can sometimes reveal complications like coil migration or other issues. If your doctor recommends removal, ensure they provide documentation that notes their findings and rationale
Gathering Documentation
Documentation is crucial. Collect all relevant medical records, including implantation details, follow-up reports, and correspondence with healthcare professionals. This portfolio of evidence bolsters your case by clearly linking your health issues to the device.
Legal Consultation
As you prepare to explore legal options, reaching out to a lawyer experienced in medical device cases is a wise move. This should ideally happen after consulting your doctor but can occur before or after a removal procedure, depending on your comfort level.
An attorney can provide strategic insight into whether an individual lawsuit or joining a class action is more appropriate for your circumstances.
Building Your Case
With the guidance of your attorney, you can build a compelling case. This involves compiling all medical evidence, your symptom journal, and any testimonies from medical professionals. Your lawyer will develop a tailored legal strategy to pursue just compensation, whether negotiating a settlement or proceeding to trial.
Every step you take is about reclaiming agency over your health and future. Lean on your support networks, whether it's friends, family, or online communities, for emotional backing while you navigate this complex journey.
You're not just a statistic—your health and story matter. So, take a few sips of calming chamomile tea, gather your notes, and know you have the strength and resilience to see this through!
