TorHoerman Law, a recognized leader in products liability cases is currently talking to women injured by the Essure permanent sterlization device. With over $3 billion in verdicts and negotiate settlements, TorHoerman Law not only believes in justice for people, we act upon it.
When asked about the Essure cases, Jessie Hoerman said
"I look forward to holding Bayer responsible for the numerous complications and injuries caused by Essure implants. This is personal to me - I am a lawyer, but I am also a wife, mother, and friend. I have friends living with life-altering injuries that wouldn't exist if they were given full disclsoure of risks. I am tired of corporate profits taking priority over women's health. I want to make a difference in the lives of the E-sisters and prevent this from happening to my own daughters. My firm will do whatever it can to stand with those that suffer from the injuries caused by Essure."
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 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 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 they 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.
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.
Until Essure is removed from the market, advocates continue to spread word of 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.
ESSURE COMPLICATIONS AND SIDE EFFECTS
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:
Pain – including abdominal, pelvic and joint pain
Heavier mensies/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)
Migration of the device or components
Device operating different than expected
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.
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 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.
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.
ESSURE – WHAT ONE DANGEROUS DEVICE TELLS US ABOUT A BROKEN SYSTEM
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 in 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 post market regulatory framework.