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Essure Contraceptive DeviceNumber of Women Experiencing Complications Continues to Grow

Essure Lawsuit

Essure permanent birth contraceptive devices have been linked to a number of adverse, life-threatening health risks. Because it is deemed to be so dangerous, Essure has been banned from almost every market globally. However, it is still currently available in the United States. As the number of domestic adverse health events continues to grow, so does the number of lawsuits filed against Essure's manufacturer, Bayer. If you have suffered an injury due to your Essure device, you may be eligible to participate in the Essure lawsuit.

Litigation Updates

Essure to be Discontinued by December, Lawsuits Moving Forward

August 2018 - Bayer announced that by the end of December, they would be discontinuing the sale of Essure®.  The removal of this device from the market is a major step in the right direction for the safety of all women. There are currently more than 15,000 Essure cases filed in state courts across the country and more women continue to come forward. We are continuing to work with other lawyers to hold Bayer accountable for the pain and suffering so many women have endured.

Bayer Discontinues Domestic Sales of Controversial Birth Control Device

July 20, 2018 -- Bayer announced today that it will discontinue US sales of the Essure birth control device, which has come under fire after thousands of women filed lawsuits against the manufacturer claiming that it caused them serious injury.

Standing by the safety of their product, Bayer said in a statement, “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable."

Although Bayer stands by the safety of their product, it seems that the question of the product’s safety has left patients and healthcare providers unconfident in Bayer’s claim.

Sales of Essure have been steadily decreasing not only domestically, but in the world market as well. The birth control device had either been banned or removed from every other available market worldwide. The US is the last market to follow suit.

Bayer said in its statement that US sales of Essure have decreased by 40 percent per year for the last few years.

Bayer attributed the steady decrease of sales to a number of factors including an increase in reversible long-acting contraceptive devices as well as a decrease in the number of women choosing to use permanent contraceptives.

 

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What is Essure?

Essure birth control is a permanent sterilization device made of two tiny metal coils that are inserted into a woman’s fallopian tubes.  The coils contain a material that stimulates inflammation and scarring, causing the tubes to close up and stop sperm from reaching the woman’s eggs.

In theory, Essure birth control should prevent pregnancy, but there have been close to 750 reports of “E-babies” since the device was approved in 2002.  Essure was first manufactured and sold by Conceptus, Inc. under the name Selective Tubal Occlusion Procedure or “S/TOP” Permanent Contraception device.  Bayer AG agreed to buy Conceptus Inc. for $1.1 billion in April 2013 so they could add the Essure device to their women’s health division, which also includes Mirena IUD  (also the subject of lawsuits filed by injured women).

As of 2013, there have been more than 750,000 Essure procedures performed worldwide since FDA Approval in 2002.

 

Essure Procedure

Essure birth control is a type of sterilization that does not require an incision/cut. It is referred to as a hysteroscopic sterilization.

During the 10 minute Essure procedure, a health care provider inserts a small, rigid, tube-like instrument called a hysteroscope into the vagina and through the cervix. Small metal coil inserts are placed in the opening of the fallopian tubes.

 

Essure Removal

Essure birth control is a permanent form of birth control and removal of the Essure device is tricky according to several doctors consulting E-sister on the “Essure Problems” Facebook Community Page.

Dr. Shawn Tassone and Dr. Julio Novoa are Obstetrician-Gynecologists who note that they have seen some crazy Essure device removal methods over the years. Dr.s Tassone and Novoa warn women to see a doctor that has been educated to remove the Essure device and provide helpful insight into removal methods and tests that should be run prior to Essure removal.

Dr. Julio Novoa compares the Essure device to an industrial piece of Velcro attached to a cotton ball. Even if you separate the cotton ball from the Velcro, you will always have tiny pieces of the cotton ball on the Velcro. For this reason, Dr. Novoa recommends that the Essure device is removed intact.

 

Essure Complications

The number of women experiencing complications continues to grow and their stories become increasingly visible thanks to social media. There are now more than 25,000 members of a closed Facebook Group called “Essure Problems”.  E-sisters on Facebook mention similar problems as those reported to the FDA including:

  • Menstrual irregularities

In addition, women report a large number of Essure device problems including:

  • Device incompatibility (symptoms of incompatibility include rashes, nickel allergies, and a metallic taste in mouth)
  • Device operating differently than expected
  • Device movement
  • Inaccurate positioning of the device

In one FDA reported case, a woman with no prior medical issues convulsed and suddenly died during the placement of Essure.  Autopsy results showed uterine perforation and blood in the abdomen.

These complications are mentioned in the claims against Essure but have not been proven to be associated risks of Essure at this time.

All known risk were are included in Essure’s warning label. In April 2015, a 5-year post-market study of Essure was published. Following the study’s publication, the FDA decided to rebrand Essure as a surgical device and required that the device include more comprehensive instructions for op/post op. In October 2015, an independent study found that women who received Essure are 10-times more likely of needing a secondary operation as compared to women who received tubal ligation.

In February 2016, the FDA required Bayer to conduct further post-market research after receiving a number of concerning adverse event reports. Bayer’s studies find that less than 1% of case report data related to pain, bleeding, device placement or migration and pregnancy were altered.

 

Essure Lawsuit

Joining the activists in the cause for removal of Essure are lawyers who are taking the fight to the courts.  Lawyers representing women injured by Essure are hopeful that Bayer will be held accountable for its defective and unreasonably dangerous product.

Despite the numbers of injured women, the Essure lawsuit against Conceptus/Bayer is facing an uphill battle.  Conceptus/Bayer has a powerful defense on their side – Federal Preemption that may prevent women from pursuing their cases in state courts

Despite the uphill battle, lawyers are currently filing cases in a number of state courts arguing that Bayer/Conceptus violated the terms of their FDA approval and therefore forfeited protection under preemption laws.

There are currently more than 10,600 lawsuits filed against Essure (Oct. 2017).

Barring statute of limitations violations, cases are still being filed on behalf of individuals injured by Essure.

Plaintiffs in the Essure lawsuit claim that Bayer is guilty of negligence and also of failing to warn the public about the risks associated with Essure. Furthermore, the lawsuits claim that the manufacturer falsified documents in order to get market approval for Essure.

 

Injuries Associated with Essure Lawsuit

The following injuries are listed in the claims against Essure:

  • Pain or bleeding
  • Device migration
  • Device fracture
  • Organ perforation
  • Complications requiring surgery
  • A child born with birth defects

These injuries have been named in the Essure lawsuit. However, not all have are included on the device label and have not definitively been proven to be associated with Essure.

 

Joining Essure Lawsuit

If you have suffered any of the aforementioned injuries as a result of your Essure device, you may be able to participate in the Essure lawsuit. To find out whether you qualify, contact the offices of TorHoerman Law. Our firm offers free no-obligation Essure lawsuit consultations. We can help determine whether you have a case against Bayer and help get you on the right path to take legal action if necessary.

 

Who Monitors the Safety of the Essure Medical Device?

The FDA is charged with the monitoring of the safety and efficacy of medical devices such as the Essure implant.

Essure was first manufactured and sold by Conceptus, Inc. under the name Selective Tubal Occlusion Procedure or “S/TOP” Permanent Contraception device.  Bayer AG agreed to buy Conceptus Inc. for $1.1 billion in April 2013 so they could acquire the permanent contraception device to their products, which also includes the Mirena IUD, which has also been the subject of a number of Mirena IUD lawsuits by injured women.

Conceptus Inc. was granted “Premarket Approval” (PMA) of the Essure device.  In addition to the information provided to the FDA at the time of approval, Conceptus (and later Bayer) agreed to provide additional information after the marketing of the device.  Failure to meet post-marketing requirements would result in the device being considered “adulterated” as defined by the FDA.  An adulterated device would invalidate the PMA and would need to be removed from the market.

 

Activists Spread Word of Essure Complications

Most of what is known today about Essure complications is a result of the grassroots efforts of activists that refer to themselves as “E-Sisters.”  Websites and Facebook community pages have been set up as support networks for women that have been injured by Essure.  In addition, many of these same advocates are behind a not for profit advocacy group, ASHES (Advocating Safety in Healthcare E-sisters) that is raising money to continue to advocate on behalf of injured E-sisters.

Grassroots advocacy has led to an increase in filed FDA adverse event reports.  Advocates encourage every injured E-sister to file voluntary FDA reports so that the FDA is aware of the extent of the problem.

Increasing patient engagement through online communities and reporting has not gone unnoticed by the FDA or Congress.  On September 24, 2015, nearly 13 years after Essure’s approval, the FDA’s Obstetrics and Gynecology Device Advisory Panel met to consider the large increase in adverse event reports related to Essure.

Numerous patients and interested individuals gave emotional testimony at the September advisory panel meeting and additional 2,833-interested individuals posted their Essure stories to a public docket. The public docket is now closed but the stories of women that were not warned of the dangers of Essure remain available for public viewing.

The FDA will announce their findings from the advisory panel at the end of February 2016.

In addition, E-sisters continue to take their grassroots efforts to Congress getting the support of U.S. Rep Mike Fitzpatrick who presented Congress with a bill ordering the withdrawal of Essure from the market.  Essure advocates continue to contact congressman at their local levels in hopes of getting support for Essure removal.

Essure advocates have also captured the attention of Erin Brockovich, who dedicates a website to the stories and voices of women facing serious medical issues after being implanted with the Essure device.  These stories are meant to save thousands of women from making a birth control decision that could negatively impact their health.

Although Essure has been removed from every market except in the United States, advocates continue to spread the word about the dangers of Essure to make sure that women facing birth control decisions are given full information about the devastating side effects of the device.

 

Timeline

FDA Issues “Unique Type of Restriction” on Essure Contraceptives

April 9, 2018  - In an effort to reduce misrepresentation of the dangers associated with Essure, the FDA has issued a "unique type of restriction" on the domestic sales of the permanent contraceptive device. According to the release, the FDA now requires that all women who are considering using Essure will be counseled by their healthcare provider to provide information on all of the potential risks involved with the permanent contraceptive device.

The FDA has restricted the sale of Essure to only healthcare facilities and medical providers that provide patients with an explicit brochure detailing the adverse health risks associated with Essure – perforation of the uterus and fallopian tubes, migration of the device, pain, and allergic reactions.

According to the release, after reviewing the brochure, the patient and her doctor are both required to sign off on a statement ensuring that the patient fully understands the risks associated with Essure.

Essure manufacturer, Bayer, will be required to ensure compliance with these newly mandated restrictions. If Bayer fails to meet these requirements, the FDA says that it is prepared to take legal action against the manufacturer.

"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still are not receiving this important information," said, FDA Commissioner Scott Gottlieb.

In November 2016, the FDA mandated Essure to carry a black-box warning label informing consumers of the risks associated with the drug. Since that information has become public and readily available, the FDA says that Essure sales have declined 70 percent.

After reviewing Essure's benefit or risk profile, Bayer says its confidence in the contraceptive device has not changed.

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Essure Discontinued in Global Market

September 18, 2017 - Bayer announced it will discontinue all sales of its Essure contraceptive device outside of the U.S. market. Despite numerous accusations questioning the product's safety, Bayer attributes the decision to a lack of consumer interest in permanent birth control in global markets.

Bayer's decision comes just months after Essure sales were suspended in a number of countries due to high rates of adverse health reports.

Domestically, Bayer has faced nearly 3,700 lawsuits from women who claim that Essure caused them severe health issues -- including allergic reactions, persistent pain, abnormal bleeding, perforation of the fallopian tubes and the necessitation of surgical removal of the contraceptive device.

In a statement on Bayer's decision to pull out of global markets, the FDA recommended that U.S. consumers who are considering using Essure should talk to their healthcare provider about the potential risks included on the black box label.

In that same statement, the FDA claimed that Bayer plans to continue risk vs. benefit analysis research on Essure.

Despite the FDA's assurance, evidence indicates that healthcare professionals are becoming less likely to recommend Essure to patients; doctors are threatened by potential costs of future litigation. Their concerns are not unfounded – in 2016 along, legal defense related to Essure cost Bayer $413 million.

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Canada Becomes 4th Country to Have Essure Withdrawn from Market

June 21, 2017 - Mounting market pressure and legal backlash have forced the hand of Bayer once again, with the pharmaceutical manufacturer announcing this week that it will be discontinuing distribution of Essure in the Canadian market.

Canada is the fourth country where Essure has been pulled from the shelves; it was recently also taken out of the market in the United Kingdom, The Netherlands, and Finland. Bayer has begun the process of soft recalls of Essure in a handful of other countries as well. Earlier this year, Brazil was the first nation to completely ban the sale of the product.

In Canada, the device is currently subject to a class-action lawsuit composed of nearly 300 women who have experienced similar adverse effects. However, Bayer’s Canadian officials continue to claim the device is still completely safe for consumers. Bayer said the decision to pull the device from the Canadian market was founded on financial issues alone, citing the change in patient demand for the product. In a press release from Bayer, the company claimed, “the favorable benefit-risk profile of Essure remains unchanged.”

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FDA Receives Updated Adverse Event Report with Essure

March 7, 2017 - The FDA began looking into new information about issues surrounding removal of Essure birth control devices. In 2016, The FDA mandated Essure to carry the strongest safety warning label and requested that Bayer conduct a post-market study after receiving thousands of adverse event reports ranging from abdominal pain, abnormal uterine bleeding, and device migration. In 2017, the FDA received almost 12,000 adverse event reports related to Essure, almost all of with which regard to potential removal of the birth control device.

"While the FDA continues to believe that Essure may be appropriate for some women based on our current information, the agency also recognizes that serious problems have been associated with its use," said Scott Gottlieb, FDA Commissioner.

FDA Refuses to Pull Essure Off Market Amid Criticism

March 6, 2016 - After six months of deliberation over thousands of complaints regarding side effects associated with the permanent birth control device Essure, the U.S. Food and Drug Administration (FDA) did not pull the device from the market, as many had hoped it would.

 

Instead, the FDA ordered Essure's manufacturer, Bayer, to launch new clinical trials for the device, and called for a boxed warning and for development of a decision checklist that patients would be required to sign before receiving the device to show that they understand its potential risks. Not only did the agency fail to take Essure off the market, but it also did not lift the legal protections given Essure during the device’s development that shield the manufacturer from subsequent product liability lawsuits.

In a statement issued February 29 after the FDA's findings were released, Bayer urged patients to talk with their physicians about the safety and appropriate use of Essure and restated the company’s commitment to "providing physicians with the resources, tools, and information to help them counsel women about Essure." Bayer also said it would continue to work closely with the FDA regarding issues involving the permanent birth control device.

The FDA acknowledged that it will likely take years for Bayer to conduct the required study involving 2,000 patients, comparing problems like unplanned pregnancy and pelvic pain, but expected the company to submit interim results by mid-2017.

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What One Bad Drug Says About The Broken Medical Device Approval System

January 23, 2016 - The system of approving devices such as Essure has come under scrutiny in recent years. In a January 2016 Health letter, Public Citizen used the Essure device as an example of a product that came out of a flawed and broken regulatory system.

In the Open Health Letter, Public Citizen asks individual consumers to contact their senators and reject regulations that would make it easier for companies like Bayer to bring dangerous devices to market.  The Health Letter notes that Essure was approved and remains on the market because the current system “allows manufacturers of many moderate and even high-risk implantable devices to sell them without testing for safety and effectiveness.”

Sarah Sorscher, a researcher at Public Citizen’s Health Research Group testified at the FDA Advisory Committee Panel on September 24, 2015.  Ms. Sorsher gave detailed testimony as to why and how Conceptus/Bayer did not provide an accurate indication of adverse events.  At the end of her testimony, Ms. Sorsher noted, "Essure's benefits do not outweigh its risks, and it should be withdrawn."

This broken FDA approval system was further studied by the Institute of Medicine Committee report, which was commissioned by the FDA.  The IOMC report concluded that the current system is flawed and resources should be used to develop an integrated premarket and postmarket regulatory framework.

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See More

+ - References

Parenthood, Planned. “Tubal Ligation Procedure | Female Sterilization | Essure.” Planned Parenthood, www.plannedparenthood.org/learn/birth-control/sterilization.

“Essure Problems.” Facebook, www.facebook.com/groups/Essureproblems/?ref=group_header.

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