Take a Stand with an Essure Lawsuit
If you or your loved one has had an Essure device implanted, life may have been flipped upside down since the procedure. It is important to stay up to date and seek counsel from lawyers who are familiar with both the medical and legal implications surrounding this defective device. Essure has been implanted in over 750,000 women and a large number of those have been coming forth with reports of horrendous unexpected side effects. The awareness for the problems with Essure is growing rapidly.
However, awareness has not been the result of education from the medical industry in the case of Essure. Instead, social media networks have led the charge in identifying affected individuals. In April of 2018, a documentary called the “Bleeding Edge” was released on Netflix. These modern methods of dissemination of information have allowed the tens of thousands of women (almost a hundred thousand) to discover they are not alone.
If you have experienced complications due to your Essure device, contact us online or by phone at (718) 624-1211 to schedule a consultation at our Brooklyn, NY, office to find out whether you may be eligible for compensation. Our knowledgeable and compassionate attorneys can help you pursue an Essure lawsuit.
This small device consists of small coils and is intended to achieve permanent sterilization.
What Is Essure?
Many mothers in their late 30s and 40s decide they had enough children. They often then seek advice from their OB/Gyn regarding permanent birth control options. Starting in 2002, OB/Gyn’s began speaking to such patients about a new birth control device called Essure. They were told it could be placed right in the office and that the women could go to work right the next day. The product was recommended as the ideal option for these women.
Essure is a permanent sterilization device. It is made out of 4 cm coils. It’s inserted through the uterus and placed inside of the fallopian tubes. It is intentionally designed to cause an inflammatory response which generates scar tissue. The scar tissue closes off the fallopian tubes permanently, blocking the sperm and the egg from meeting, therefore preventing pregnancy.
According to Bayer’s most recent financial reports, there are more than 16,000 lawsuits in both federal and state courts across the United States.
During the procedure, the Essure device is threaded through an introducer while the physician holds the hysteroscope. The Essure is threaded into the fallopian tube.
Advertised Benefits of Essure
Essure was originally designed by Conceptus which was acquired by Bayer in 2013 for approximately 1 billion dollars.
It was marketed as a better choice than the traditional tubal ligation because it did not require any incisions, and, because there are no incisions, the procedure does not leave any scars. The short discharge time was also advertised.
Women Begin to Experience Negative Side Effects
The women were told the procedure would be painless. However, in many cases, as soon as they stepped out of the doctor’s office, they began experiencing cramping pain. This was followed by heavier menstrual bleeding during the following weeks.
When they contacted their physicians about these symptoms, they were met by skepticism and disbelief. Many of these women report they were simply assured that Essure would not cause these symptoms because it is just a small coil. Many of them experienced fevers and pain following the procedure.
However, we now know Essure devices can trigger women’s immune systems, leading to systemic inflammatory responses akin to autoimmune disease. In fact, Bayer later admitted this. Women developed a type of connective tissue disorder. Some have described joint pain discovered to be inflammatory arthritis. The entire body’s immune system can be set off by the complex foreign materials which make up Essure. If you think about it, that makes sense given what the purpose of Essure is - cause inflammation.
Medical Intervention
Some women’s Essure devices dislodged out of the fallopian tubes and ended in the uterus. These had to be removed in an additional procedure and the women were informed they should begin feeling better. However, some experienced continued bleeding and recurrence of symptoms. Others experienced dangerous hemorrhages with blood clots. Many women experience severe headaches.
These symptoms often worsened. Severe pain forces many to present for repeated hospitalizations. Some lose consciousness due to the severity of the pain. Many are unable to work and struggle to take care of their children.
Doctors attempted to remove the Essure devices from these women only to find out that the device breaks up into tiny fibers. These women were therefore recommended to undergo hysterectomies. The surgeries could necessitate revision surgeries to repair the vaginal cuff.
Some report having to wear diapers due to incontinence as well as sexual dysfunction. Their relationships are understandably strained due to this if they last at all. Many Hispanic women report their symptoms were dismissed by providers as being attributable to their “Latin heritage,” which is associated with “heavy periods.” These are women who were completely healthy prior to the placement of Essure, leading normal and active lives.
Social Media Exposure
In 2011, frustrated by the lack of information and answers regarding these symptoms, a brave woman by the name of Angie Firmalino started a Facebook group called Essure Problems to inform her friends and family. To her surprise, many women she did not know began writing comments on her page regarding their similar experiences with Essure.
Premarket Approval
Through the group, they discovered that Essure went through a process called PMA (premarket approval) and that it is not very strict. It requires only one study with a few people. A group member found the transcript for the 2002 approval meeting by the FDA and the group then purchased the video recording of the Essure approval meeting.
The video revealed that the principal investigator for Essure had a financial interest in the company (he owned stock in the company). Not much data was available for the questions asked of the company by the FDA. Many open questions remained at the end of the meeting. A joke was made during the meeting regarding what would happen if problems were discovered in 10 years.
The manufacturer has changed the removal protocol for Essure 3 times, often contradicting itself as to the correct steps for removal. Many doctors are therefore not aware of any correct way to remove them and the devices are often broken during extraction. If you pull or stretch the Essure coils, fragments may remain behind. When these fragments remain they cause an even more robust immune response.
Bayer has admitted that Essure can cause an autoimmune response in a “small percentage” of women. An “Essure Autoimmune Disease Survivors” group on Facebook has documented this number is not so small.
Pregnancy & Health Issues Caused by Essure
After receiving reports of a significant rate of women becoming pregnant after being implanted with Essure, a 'parents of “e-babies”' Facebook group has been created. The babies are showing a pattern of abnormalities as a result of the Essure. In addition, many babies are premature due to injury from the Essure.
Some women have had multiple coils placed in them as per direction from company representatives to doctors’ incorrect placement of coils.
Women with Essure problems are often rendered unable to do the normal activities of life they used to do, creating an enormous burden on themselves and their families. Their moods are affected. Many lose their interest in living and begin having suicidal ideation.
Removal from the Market
The Essure device was not tested for a sufficient amount of time. Most patients who had the Essure device were followed for 12 to 18 months. During the study, many women report they were not asked whether they felt ill. They report that the nurses who questioned them manipulated the answers on their questionnaires to make it seem as if they were not experiencing the negative side effects. The Facebook Essure groups spread to dozens of countries around the world.
The European equivalent of the FDA then demanded Bayer provide them with more safety data. Bayer then decided to withdraw Essure off the market in Europe in September of 2017 due to “lack of interest.” However, the product continued to be sold in the US. Only in July of 2018 did Bayer announce it will stop selling the product in the US in December.
Thousands of Victims Have Filed Lawsuits
According to Bayer’s most recent financial reports, there are more than 16,000 lawsuits in both federal and state courts across the United States.
In 2016, a group of plaintiffs submitted a petition to transfer their cases using the MDL process overseen by a Judicial Panel on Multidistrict Litigation. However, a judge in the Eastern District of Pennsylvania agreed to consolidate the cases in that court so the motion for an MDL was withdrawn, and the cases remained separate.
Women with Essure problems are often rendered unable to do the normal activities of life they used to do, creating an enormous burden on themselves and their families.
Some states, such as California, have established processes to coordinate Essure cases using processes similar to the MDL system. In California, Assistant Presiding Judge Winifred Y. Smith of the Alameda County Superior Court granted a petition to consolidate all Essure lawsuits filed which would proceed under Judicial Council Coordination Proceedings (JCCP).
https://www.personalinjury.com/blog/essure-litigation-mdl-2739-jccp-4887
Formation of Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887 was followed by appointments to the Plaintiff’s Steering Committee (PSC) in February 2017, to initiate, coordinate, and conduct all pre-trial discovery on behalf of the plaintiffs and also provide input to the Executive Committee.
Apart from California, several groups of Essure cases have been coordinated in other courts with additional federal lawsuits consolidated in the US District Court for the Eastern District of Pennsylvania.
As of early 2018, no federal MDL has been established.
Do Not Wait to Seek Legal Assistance
At Zucker & Regev, P.C. in Brooklyn, we firmly believe that Bayer should be held responsible for their negligent actions and the pain and suffering Essure has caused you. Our team of attorneys can help you find the justice you deserve. Schedule your consultation today by contacting us online or calling us at (718) 624-1211.
