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Intro

In the realm of birth control, where advancements promise freedom and convenience, there’s a darker side that often goes unnoticed: unforeseen complications. Essure, once hailed as a groundbreaking permanent contraceptive, isn’t the worry-free solution it first appeared to be.  

While Essure aimed to revolutionize women’s healthcare with its non-surgical approach, it wasn’t immune to the complex challenges of medical technology. With thousands of women affected and numerous reports of adverse effects, it’s clear that the initial promise of Essure missed significant risks. 

As the conversation around Essure’s complications continues to unfold, it’s crucial to examine the broader implications on women’s health and medical device regulation. From the initial optimism to the subsequent fallout, Essure’s story underscores the importance of thorough testing and transparent communication in medical advancements. 

Key Points: 

  1. Non-Surgical Permanent Birth Control: Essure was introduced as a pioneering permanent birth control method that did not require surgery. Instead, it involved inserting small metal coils into the fallopian tubes, which caused scar tissue to form and block the tubes, preventing pregnancy. 
  1. Initial Popularity and Trust: Launched in 2002, Essure quickly gained popularity among women seeking a reliable and permanent contraceptive solution without the need for invasive surgical procedures like tubal ligation. 
  1. Severe Complications and Health Risks: Over time, thousands of women reported severe complications, including chronic pain, device migration, organ perforation, allergic reactions to the metal coils, and even death. These adverse effects led to significant health issues and numerous lawsuits. 
  1. Regulatory and Legal Issues: The rising number of complaints and reported complications prompted regulatory scrutiny and legal actions. In 2018, Bayer, the manufacturer of Essure, announced it would stop selling the device in the U.S., although it did not explicitly cite safety concerns as the reason. In 2017, the sterilization device was taken off the market in the European Union.  
  1. Lessons for Future Medical Innovations: The Essure controversy highlights the need for rigorous testing, transparent risk communication, and robust regulatory oversight in the development and approval of medical devices. It underscores the importance of balancing innovation with patient safety and informed consent. 

Essure Explained

What Happened with Essure Birth Control 

Essure was launched in 2002 as an innovative, non-surgical option for permanent birth control, using small metal coils inserted into the fallopian tubes. Initially popular for its simplicity, Essure soon became controversial as thousands of women reported a range of severe complications. These issues led to significant health problems and the need for additional surgeries. 

Due to the rising number of complaints, the U.S. Food and Drug Administration (FDA) imposed strict regulations and warnings on Essure. In 2018, Bayer, the manufacturer, ceased sales of the device in the U.S., citing declining demand. 

In response to the widespread complications, Bayer agreed in 2020 to a $1.6 billion settlement to address US claims from women who suffered from Essure-related issues. This settlement opened the possibility for the affected women in the US to claim compensation for their suffering, highlighting the need for robust oversight and patient safety in medical device approvals. 

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Legal Proceedings and Essure Settlement 

The legal proceedings surrounding Essure, a non-surgical permanent birth control device, culminated in a significant settlement after widespread reports of severe complications. Following its introduction in 2002, Essure faced mounting complaints from thousands of women that resulted in unplanned pregnancies, undergoing hysterectomies, and even death. These adverse effects led to numerous lawsuits against Bayer, the device’s manufacturer. 

The U.S. Food and Drug Administration (FDA) responded with strict regulations and warnings on Essure, specifically labeling the device with a “black box warning”, but the complaints persisted. Amid increasing scrutiny, Bayer halted U.S. sales of Essure in 2018. In 2020, Bayer agreed to a $1.6 billion settlement to resolve approximately 39,000 claims from women affected by the device. This settlement provided financial compensation for those who suffered from Essure-related health issues, marking a critical moment in the legal battle. On a global scale, legal proceedings regarding Essure are ongoing, and women still have an opportunity to participate in group actions. 

The Essure case underscores the importance of thorough clinical testing and regulatory oversight in the medical device industry, ensuring that patient safety remains paramount and that companies are held accountable for their products.  

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Impact of Essure on Users 

Essure birth control presents a complex landscape of pros and cons for its users and the broader healthcare community. On the positive side, Essure offered a minimally invasive, non-surgical alternative to permanent contraception, which appealed to many women for its convenience and swift recovery compared to surgical sterilization methods. It provided a reliable, long-term solution to prevent unintended pregnancies, empowering women to manage their reproductive health effectively. 

However, the device has also been associated with significant drawbacks. Reports of adverse effects such as chronic pelvic pain, allergic reactions to nickel components, and device migration raised serious safety concerns. These complications often required additional surgeries for removal, causing distress and discomfort for affected women. The controversies surrounding Essure prompted regulatory scrutiny and legal actions in multiple countries, leading to its withdrawal from several markets. 

In the bigger picture, Essure’s case highlights the complexities of balancing innovation and patient safety in medical device regulation. It emphasizes the importance of rigorous pre-market evaluation, ongoing monitoring of device safety post-approval, and transparent communication of risks to healthcare providers and patients. 





How to Claim Essure Compensation

If you have experienced serious complications from the Essure implant, you might be eligible for compensation. At Remunzo, we are here to make the process as smooth and stress-free as possible. Our expert team, in partnership with a top law firm, will handle everything for you, and with our No Win No Fee policy, you won’t pay any legal costs unless we win your case. 

Getting started is simple. Sign up for a free case evaluation to check your eligibility. We’ll manage all the legal work and keep you informed every step of the way. Don’t wait—contact us today at info@remunzo.com or sign up on our platform to begin. 

Remunzo does all the heavy lifting. We take the fight to the corporation, ensuring they are held accountable. When you join thousands of others in this lawsuit, it increases the chances of a higher settlement for everyone involved. 

Stay patient, as these cases can take some time, but rest assured, we will keep you updated on the progress.  Start your journey to compensation today! 

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Sources

  1. https://www.forbes.com/advisor/legal/product-liability/essure-lawsuit-update/ 
  2. https://www.bbc.com/news/health-66709076  
  3. https://www.mddionline.com/regulatory-quality/the-essure-death-reports-in-fda-s-database-are-confusing-but-tragic  
  4. https://www.bayer.com/media/en-us/bayer-announces-resolution-of-us-essuretm-claims/  
  5. https://nypost.com/2022/11/14/woman-tells-contraceptive-horror-story-dying-from-inside-out/  

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