ESSURE GROUP ACTION
WHY YOU SHOULD TAKE ACTION
Be Heard. Help Other Women. Get the Compensation You Deserve.
Are you among the estimated 100,000 women in the UK who were fitted with an Essure implant? If so, you may be eligible to join our group action and claim compensation.
Essure, manufactured by Bayer HealthCare, is the only non-surgical permanent form of birth control for women in the UK. Made of a metal coil and plastic PET fibers, the device is known to slice through the uterus and fallopian tubes, migrate into the pelvis or abdomen, and cause allergic and autoimmune reaction to the materials, maiming thousands of women like you. Left in crippling pain and facing limited treatment options, many women have had to endure multiple surgeries to remove Essure, a complex procedure that often calls for a total hysterectomy in order to remove the tiny metal fragments that break off from the device.
We believe you and know your pain is real.
For far too long women’s pain has been ignored and dismissed by the medical profession whilst women in the UK continued to receive Essure implants. Stop suffering in silence.
THIS CLAIM RELATES ONLY TO ESSURE.
Essure is a permanent sterilization process which is different than a coil, Mirena or Filshie clip. The Essure device has springs which are placed into both fallopian tubes to create a barrier, or scarring. This is caused by pet fibres within the Essure coils or springs.
Unlike other methods, Essure is normally fitted whilst a patient is awake. If someone is unsure about which method was used, they can contact their GP or the hospital that carried out the process.
SPG LAW IS DEDICATED TO AMPLIFYING YOUR VOICE AND CHAMPIONING YOU
We have assembled a powerful team of the UK’s leading solicitors and barristers reinforced with the financial resources and tested expertise of American class action lawyers to ensure that your case is aggressively litigated against Bayer.
We are passionate about winning this group action! SPG Law’s American partners currently represent over 1,500 women in the United States who have received Essure implants and have already won over $1 billion of compensation for consumers in similar cases.
We operate on a no-win, no-fee basis, and unlike other law firms, we cap our fees and aim to secure the maximum compensation owed to you for your pain and suffering and financial losses. We do everything for you and make your claim simple.
Join together with thousands of other determined women in the UK and hold Essure’s manufacturer to account!
JOIN OUR ESSURE SUPPORT GROUP ON FACEBOOK
Join with Jan and hundreds of other ladies in the UK and Ireland who have are helping each other through the challenges of Essure.
We support each other everyday through the highs and the lows both online and through our regular meetups around the UK.
AM I ELIGIBLE TO FILE
AN ESSURE CLAIM?
Conceptus, who developed Essure and was later acquired by Bayer, failed to properly research, design and test Essure and then sold this unreasonably dangerous device without adequately warning women and the medical community about its risks. In the UK and around the world, thousands of women have been harmed as a result.
SPG Law is committed to seeking justice for these women.
If you have experienced any of the following side effects as a result of your Essure implant, you may be eligible for compensation:
WHAT KIND OF COMPENSATION WILL I RECEIVE?
SPG Law understands that no amount of money can repair bodies, broken families or the loss of loved ones that has resulted from Essure complications. In many cases, compensation can pay for the extensive treatments and multiple repair surgeries needed to survive and improve your quality of life. For many of our clients, compensation is more than money: it’s public vindication that the medical community should have listened to you and taken your concerns seriously. It’s a way to hold Essure’s manufacturer to account and save other women from being harmed in the future.
We have litigated thousands of similar cases in the USA and have secured compensation for our clients for the following:
We are committed to achieving the same levels of maximum compensation for your claim.
SPG LAW IS AN INTERNATIONALLY RECOGNISED LAW FIRM
REASONS TO TAKE ACTION
Join thousands of other women to stand against Essure’s manufacturer and let your voice be heard.
Help other women learn about the dangers of Essure.
Receive compensation for your pain and suffering, medical expenses, and loss of wages.
WE MAKE IT SIMPLE
SPG will ensure that the process is simple and straightforward.
Currently in the US, Bayer is facing over 16,000 lawsuits filed by women who experienced injuries and complications from Essure implants. Despite 30,000 patients reporting problems about Essure to the FDA, the pharmaceutical company is staunchly defending itself against allegations that it intentionally misled women and actively concealed negative reports about the device from the FDA.
While Bayer voluntarily withdrew sales of Essure from the UK market in September 2017, neither it nor the Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall of the device. Sadly, this means more women can receive an Essure implant from already sold stock.
Shockingly, Essure was approved in 2002 with little testing, shepherded in a fast-track FDA approval process by a company executive who also served on the FDA panel responsible for reviewing the safety and efficacy of contraceptive devices. Required to conduct a 5-year follow-up study after Essure’s approval, Bayer was 8 years late in publishing its finding and only 70% of participants had been tracked.
In another example of profit over patient safety, Essure’s labelling was changed so that doctors would no longer be required to test women for nickel allergies and could still offer Essure to women allergic to nickel. Approximately 55% of the Essure is made of nickel and 20% of women have nickel allergies.
Even when Essure’s labelling was modified again in 2016 to include a Black Box Warning (the most serious warning label that can be placed on a medical device), it made little difference in forewarning women of the risks of Essure since many patients are not provided with Essure’s packaging. Moreover, the Patient Decision Checklist, crafted to ensure informed consent, was never mandated until after Essure was pulled from the UK market.
The depth and breadth of this scandal is truly appalling:
ESSURE MANUFACTURER'S GUILT
Sanket Dhruva, a Yale University cardiologist and researcher of high-risk medical devices on Essure only undergoing a 1-year follow-up study with women prior to it being approved for sale.
Peter Schalock, a Boston-area dermatologist and expert in metal hypersensitivity and member of the Center for Devices’ OB/GYN devices advisory panel, questioning the FDA and Bayer on the issue of nickel sensitivity in a 2015 FDA scheduled public hearing on Essure.
Steven Bacich, the former CEO of Conceptus.
Domecus concurrently served as the Sr VP of Clinical Research & Regulatory Affairs at Conceptus and as a committee member of the FDA’s Obstetrics & Gynecology Device Panel, the body responsible for reviewing the safety and efficacy of contraceptive devices.
Mitchell Creinin, professor of obstetrics & gynecology for the University of California at Davis Health System, who stopped using Essure with patients after re-examining clinical studies cited in Essure’s approval and concluding it was not nearly as effective as doctors and patients had been led to believe.
Dr. Scott Gottlieb, FDA Commissioner in response to Bayer’s announcement that it would be withdrawing Essure from the US market.
Dr. Yesmean Wahdan, an OB/GYN at Bayer US Medical Affairs, Women’s Healthcare, announcing the withdrawal of Essure from the US market and skirting the real reasons for the 70% plummet in Essure sales: years of litigation stemming from the 26,773 complaints received by the FDA and 30,000 received by Bayer about Essure.
If Bayer knows the irreparable harm and permanent side effects that Essure complications cause, why does the company continue to deny women compensation?
A. Yes, whether or not your Essure implant was removed, you are eligible to make a claim. In some cases, women who have had one or more surgeries to remove the Essure implant may be eligible for additional compensation due to the extensive pain and suffering they endured.
A. There have not yet been any major verdicts or settlements in Essure lawsuits against the manufacturer, Bayer HealthCare. However, if you have experienced complications, you may be able to make a claim. The level of compensation you may receive can vary based on a number of factors, including:
- How long you suffered severe side effects of the Essure implant
- The severity of the side effects you’ve experienced
- Medical costs of treatment to resolve or manage these side effects
- Loss of wages due to inability to work as a result of medical problems related to the device
A. Essure lawsuits are complicated, especially since there have not yet been any major decisions in these cases. If you are thinking of filing a claim, then you need an experienced lawyer who understands the medical issues associated with your case, as well as how to navigate the legal challenges in complex medical device litigations. Our lawyers can handle all aspects of filing and fighting your case so that you can concentrate on your health and your family.
A. Probably not. If Essure’s manufacturer insists on defending the case all the way to trial, then a handful of claimants will be selected out of the thousands who we believe will participate in the action in order to give evidence. Anyway, going to court is nothing to be afraid of– Bayer is in the wrong!
A. Nothing upfront. In signing up, you will be asked to enter into a “no win, no fee” agreement with us. Under the terms of this agreement, you will only be liable to pay our fees and expenses, as well as those of barristers, funders and insurers, if the case is successful. The exact amount you will pay will depend upon how long the case takes, how much time the lawyers need to spend on it, and the level of compensation obtained. Unlike some other firms, we cap our fees at a maximum of 35% of damages (although the actual deduction from your damages may be much lower) and unlike some other firms, we aim to secure the maximum compensation owed to you for your pain and suffering and financial losses.
A. It takes less than a minute to complete the form to arrange contact. One of our specially trained Essure client representatives will then contact you to learn more about your individual circumstances. Often times this contact will come in the form of an email survey. The process will only take a few minutes. Once you have submitted your survey results, we will be back in touch with you within the next few weeks to discuss the possibility of representing you for this Group Litigation.
A. Name, email, phone number, and address.
A. If you were implanted with Essure and had complications which resulted in the removal of the device, or if your doctor has recommended that you have Essure removed, you may have grounds for a claim. One of our specially trained Essure client representatives will contact you and ask a few simple questions and then advise you on if you are eligible to join the group litigation, all at no cost to you. There is no risk and all of your information is kept confidential.
A. The timeline of an Essure lawsuit will depend on a variety of individual factors unique to the case. All of the lawyers in the action are committed to obtaining compensation on your behalf as quickly as possible. We are currently investigating cases involving women who had Essure removed or were advised to have it removed due to complications, and are committed to fighting for our clients throughout the litigation process.
As Essure’s manufacturer, Bayer Healthcare is one of largest and richest companies in the world, however, it may be necessary to take them to court. If a quick settlement is achieved, you may receive your compensation in the next six months, but if Bayer chooses to continue to fight, it could take two to three years
A. In September 2017, Bayer announced it was ending non-US sales of Essure, including in the UK. If you currently have an Essure implant and are experiencing serious side effects, speak with your doctor about your options. Our lawyers are also here to help you determine whether you are able to file an Essure claim.
A. Essure is a device sold as a permanent, non-surgical birth control solution for women. First approved for use by the FDA in the US in 2002, the sterilization procedure permanently prevents a woman from being able to conceive. Essure is a pair of metal and fiber coils that are inserted into the fallopian tubes by a healthcare provider. After a three-month period, scar tissue forms around the coils of the implant, creating a barrier that prevents sperm from reaching the eggs. Essure was initially manufactured by Conceptus, Inc., which was later bought by Bayer HealthCare in 2013, but has spawned increasing reports of dangerous side effects associated with the device.
A. Despite the many health risks associated with Essure, neither Bayer nor the Medicines & Healthcare Products Regulatory Agency (MHRA) has issued a recall of the device. On September 1, 2017, however, Bayer announced that it would voluntarily withdraw Essure from all non-US markets.
A. A recall occurs when a medical device regulatory agency or a company determines that a product, such as a medical device like Essure, contains defects or risks that outweigh the device’s supposed benefits. During a recall, the manufacturing company must proactively inform consumers of the dangers and take steps to recover all unused products from the market.
In the case of Essure, Bayer voluntarily removed the device from the UK market in September 2017. The company cited declining sales after the Black Box Warning as the reason for this decision. This means there will be no new Essure devices pushed out onto the market.
A. According to Bayer, Essure is not an intrauterine device (IUD) because Essure is intended to be permanent. Essure was not designed for removal, and the sterilization process is generally irreversible. IUDs are birth control devices that are designed to be removed.
A. According to Bayer, the Essure birth control implant is intended to be permanent. Therefore, Essure reversal generally requires invasive surgery, and these procedures can be risky. The coil implants are fragile and may break during the removal process. As a result, tiny metal fragments may remain in the uterus and/or fallopian tubes after device removal. These fragments may migrate to other areas of the body as well, causing serious issues. In some cases, women experience such intense complications that a total hysterectomy is necessary.
A. Your claim will likely be brought as part of a Group Litigation Order (a “GLO”) which is the mechanism by which the courts in England and Wales manage thousands of cases which are all brought together at the same time.
A. The Consumer Protection Act 1987 and the Law of Negligence.
A. No. We will arrange all necessary insurance and funding on your behalf.
A. Essure’s manufacturer, Bayer HealthCare is one of the largest companies in the world with unlimited resources to spend to seek to prevent you from receiving your compensation. Millions of pounds of funding and insurance is, therefore, necessary in order to be able to bring the action against them.
A. Yes, if you work for Essure’s manufacturer and have or previously had an Essure implant, you may be eligible to make a claim.
A. You won’t be able to join the Group Litigation in England and Wales.