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Essure Group Action

WHY YOU SHOULD TAKE ACTION

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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:

Infection, pain, discomfort, allergic reaction or irritation near the surgery site

Chronic pain in pelvis, groin, legs, or feet

Perforation of the uterus, fallopian tubes, or other organs

Migration of the device to the lower abdomen and pelvis

Device breakage

Malposition

Abnormal and/or heavy bleeding, severe menstrual cramps

Pain during sexual intercourse (dyspareunia)

Bloating, weight gain

Fatigue, muscle weakness

Headaches

Pregnancy, ectopic pregnancy

Miscarriage

Depression

Skin allergies

Hair loss

Autoimmune disorders

Death

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:

Medical expenses, including surgery to remove the implant

Loss of wages

Pain and suffering

Lower quality of life

Loss of consortium (loss of marital relations)

We are committed to achieving the same levels of maximum compensation for your claim.

SPG LAW IS AN INTERNATIONALLY RECOGNISED LAW FIRM

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reasons to take action

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BE HEARD

Join thousands of other women to stand against Essure's manufacturer and let your voice be heard.

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RAISE AWARENESS

Help other women learn about the dangers of Essure.

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FINANCIAL GAIN

Receive compensation for your pain and suffering, medical expenses, and loss of wages.

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WE MAKE IT SIMPLE

SPG will ensure that the process is simple and straightforward.

The scandal

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:

Timeline
  • Jan 1, 1970
    November 4, 2002

    FDA fast-tracks the application, granting Essure developer, Conceptus approval to market the device in the US.

  • Jan 1, 1970
    2009

    Essure first marketed in the UK.

  • Jan 1, 1970
    2013

    Bayer acquires Conceptus for $1.1 billion.

  • Jan 1, 1970
    2014

    First lawsuit filed against Bayer with allegations that the pharmaceutical company intentionally misled women implanted with Essure and actively concealed negative reports about the device from the FDA.

  • Jan 1, 1970
    September 2015

    FDA holds first public hearing on Essure after receiving 5,000 adverse event reports on the device.

  • Oct 2, 2018
    February 2016

    FDA orders Bayer to a post-market surveillance study to investigate the safety and efficacy of Essure.

  • Jan 1, 1970
    October 2016

    FDA recommends Essure include a Black Box Warning and a Patient Decision Checklist to ensure informed consent and that patients are made aware of the risks of using the birth control method.

  • Jan 1, 1970
    November 2016

    Bayer adopts the FDA's recommendations and adds the boxed warning and patient checklist to Essure labelling, however, not all doctors opt to ask patients to sign the Patient Decision Checklist since it is not mandatory.

  • Jan 1, 1970
    End of 2016

    FDA reports sales of Essure plummeted by 70% after implementation of Black Box Warning.

  • Jan 1, 1970
    February 20, 2017

    Brazil bans the sale and distribution of Essure and issues a recall of all devices.

  • Jan 1, 1970
    May 29, 2017

    Bayer announces withdrawal of Essure from the Netherlands market with the discontinuation for sale and distribution effective July 1, 2017.

  • Jan 1, 1970
    May 31, 2017

    Bayer announces withdrawal of Essure from the Finland market with the discontinuation for sale and distribution effective June 25, 2017.

  • Dec 11, 2018
    June 16, 2017

    Bayer announces withdrawal of Essure from the Canada market over the course of following few months.

  • Dec 11, 2018
    August 2017

    European Union suspends sales of Essure in the 28-nation bloc for three months from August in response to regulatory concern. The EU's suspension means that while the sale of Essure is banned, already-sold implants in the supply chain could still be administered by doctors. UK hospitals urged to avoid using the device.

  • Dec 11, 2018
    September 1, 2017

    Bayer voluntarily ends non-US sales of Essure.

  • Dec 11, 2018
    End of 2017

    FDA receives nearly 26,773 complaints about Essure from US patients from 2002 through 2017. Bayer has also independently received over 30,000 complaints about the device.

  • Dec 11, 2018
    April 2018

    FDA, in a partial reversal of its October 2016 decision, makes Patient Decision Checklist mandatory for all doctors.

  • Dec 11, 2018
    July 20, 2018

    Bayer announces it will no longer distribute or sell Essure in the US beyond December 31, 2018, citing it as a “business decision” spurred by a 40% drop in US sales in recent years. However, doctors will still be able to perform Essure procedures in the US throughout 2019, until they are asked to return unused devices at the end of the year.

  • Dec 11, 2018
    Present

    Essure lawsuits continue to be filed globally with over 16,000 in the US alone. SPG Law brings its expertise to the UK to help women globally get justice and the compensation they deserve.

Essure Manufacturer's Guilt

“It is the strength of the data [...] and the expertise of Cindy Domecus and the entire regulatory and clinical research staffs in working together with the FDA that enabled us to pursue an accelerated regulatory timeline.”

 

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.

I think the way the company provides information to [doctors] and patients is not the entire story. The company’s goal is to sell its product.”

 

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.

The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”

 

Dr. Scott Gottlieb, FDA Commissioner in response to Bayer’s announcement that it would be withdrawing Essure from the US market.

“[Bayer] has made a business decision to discontinue sales and distribution because of a decline in sales.”

 

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. 

“...the risks of long-term implantation are unknown. [A short-term study] might be okay if it’s a medication that you take for a week.  But we’re talking about a device that’s going to be implanted in a million people for the rest of their lives.”

 

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.

“How do we not have data on nickel allergy when we have a device that’s 55% nickel and 20% of women-- approximate numbers-- are known to be nickel allergic?”

 

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.

If Bayer knows the irreparable harm and permanent side effects that Essure complications cause, why does the company continue to deny women compensation?

FAQs

Q. I HAD MY ESSURE IMPLANT REMOVED. AM I STILL ELIGIBLE TO MAKE A CLAIM?

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.

Q. HOW MUCH COMPENSATION WILL I RECEIVE?

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

Q. DO I NEED AN ESSURE LAWYER TO FILE A CLAIM?

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.

Q. WILL I HAVE TO GO TO COURT?

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!

Q. WHAT WILL IT COST ME TO BRING THE CLAIM AGAINST ESSURE’S MANUFACTURER?

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.

Q. HOW LONG DOES IT TAKE TO SIGN UP?

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.

Q.WHAT INFORMATION DO I NEED TO SUBMIT TO SIGN UP?

A. Name, email, phone number, and address.

Q. HOW DO I KNOW IF I’M ELIGIBLE FOR COMPENSATION?

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.

Q. WHEN CAN I EXPECT TO RECEIVE MY COMPENSATION?

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

Q. SINCE BAYER HAS DISCONTINUED ESSURE IN THE UK, WHAT DO I DO IF I HAVE AN IMPLANT?

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.

Q. WHAT IS ESSURE?

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.

Q. WAS ESSURE RECALLED?

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.

Q. WHAT IS THE DIFFERENCE BETWEEN A RECALL AND A PRODUCT BEING WITHDRAWN FROM THE MARKET?

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.

Q. IS ESSURE AN IUD?

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.

Q. IS THERE AN ESSURE REVERSAL PROCESS?

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.

Q. HOW WILL YOU BRING MY CLAIM?

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.

Q. WHAT LAWS ARE BEING USED TO BRING THE CLAIM AGAINST ESSURE’S MANUFACTURER?

A. The Consumer Protection Act 1987 and the Law of Negligence.

Q. WILL I HAVE TO PAY ESSURE’S MANUFACTURER COSTS IF THE CLAIM IS LOST?

A. No.  We will arrange all necessary insurance and funding on your behalf.

Q. WHY ARE FUNDERS AND INSURERS INVOLVED IN THE ACTION?

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.

Q. I WORK FOR BAYER HEALTHCARE, AM I STILL ELIGIBLE TO JOIN THIS GROUP LITIGATION?

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.

Q. CAN I BRING A CLAIM IF I RESIDE IN SCOTLAND, NORTHERN IRELAND, THE REPUBLIC OF IRELAND, THE CHANNEL OF ISLANDS OR ISLE OF MAN?

A. You won’t be able to join the Group Litigation in England and Wales.