Essure Lawsuit

Essure Procedure

Essure birth control is a type of sterilization that does not require an incision/cut.

It is referred to as 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. Tassone and Dr. 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 like 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 risks 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 second 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.

Activists Spread Word of Essure Complications

Most of what is known today about Essure complications are 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 nonprofit 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 its 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 congressmen 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.