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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.

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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 definitively have not been proven to be associated risks of Essure at this time.

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, lawsuits against Conceptus/Bayer are 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
  • Child born with birth defects

These injuries have been named in the lawsuits. 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 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.

 

+ - 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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