As always, thank you for your interest in covering our Essure journey. Yesterdays announcement about 5 cases in PA surviving some preemption claims was a huge milestone that many doubted we would ever reach. As someone who has served in the research role for Essure Problems over the past several years, I am humbled that women may now be able to seek justice for their injuries. Having felt mislead and wrongfully harmed by Essure, it is our civil right to have our claims heard within the justice system and I am faithful we will prevail. I pray that whatever is now discovered within the courts will assist us in accomplishing our final mission which is and always has been preventing other women from harm by getting the Essure devices permanently banned.
Yesterday was a huge victory for us. The order from Judge Padova was a long time coming. I have invested five years of my life trying to help, and also educate, women harmed by Essure. We have been fighting to expose the truth about the dangers of, and the corruption behind this device. To finally hear that we WILL have our day in court was cause for celebration. The order could not have come at a better time, as we recently were let down, yet again, by our FDA. Their announcement to continue to stall the inevitable fate of Essure was weighing heavy on many of our shoulders, though we had no intention to give up, or even slow down. In fact, it fueled our fire to continue our mission of lobbying Congress to pass the E-Free Act, and revoke PMA from Essure. While we are pleased that we now have at least two, and possibly more, causes of action to pursue in court, we will not stop until preemption no longer exists.
Then, and only then, will I be satisfied.
While yesterday's judicial decision in Pennsylvania is monumental, it does not negate the fact that thousands of women are suffering and will continue to suffer from a substandard and dangerous product , that is still on the market.
A black box warning does not encompass all that is necessary to protect women from harm. Birth control should not be life altering and life changing. A birth control devices side effects should not include losing female organs , nor should it include permanent side effects that are life altering and effect the quality of life.
Elena Marie Mendez
When I first heard about preemption, class lll devices and Essure being protected under the PMA law, I thought it was a joke. No way in 21st century was there a law in place that allows manufacturers to be 100% exempt from litigation. How is it that we live in one of the freest countries in the world and have no right to go after the ones that caused us harm? How is it the governing agency for our health and safety has the right to protect a company before the people? The FDA's recent announcement of implementing a black box on Essure proves that this current system has major flaws. The FDA is for consumer protection, they are not suppose to be industry representatives.
Judge Padova's decision on the Essure cases was a historical moment in thousands of lives. We have been told by many, that moment would never exist and cutting our losses was the easiest solution. Instead of heeding to the warnings, we decided to raise awareness and fight. We are fighting for our basic rights, future victims of this device and for our daughters. We fought when we hurt, when we're sick and tired. We fight as victims, wives, women, mothers and E-sisters.
It's unacceptable for Bayer and the FDA to allow one more woman to undergo a procedure with such an inferior product. Although this may seem like a small step to some, these court cases represent our civil rights being restored. I personally look forward to our day in court with Bayer.
At first I thought I was the only one that suffered from essure problems. Once the facebook groups were formed I quickly realized I was not the only one. I couldn't believe the rate the group was growing. Then I heard about the Preemption. It took me a bit to realize what it meant. I felt ABSOLUTELY disgusted that such a Pharmaceutical company could be protected by the very people that were suppose to be protecting the American Citizens. There are women and children dying and tens of thousands of women and families suffering the devastating adverse effects of this terrible device. The decision by the FDA to allow this faulty product to remain on the market is a despicable mistake that will cost lives of women at the hand of the FDA. The decision for Judge Padova to rule that the manufacturer Bayer Failed to warn and allow these cases through this Preemption clause is a bit of justice to us as the women harmed. I will enjoy watching Bayer pay for what they have done to thousands of families including mine. We cannot get our lives back. We cannot remove scars. We cannot get our body parts and health back. So I commend Judge Padova’s Decision, Because the least we can get is our civil rights back. Bayer Does not deserve to carry a PMA. It is time for them to be held responsible for their actions that have lead to lives lost.
When I agreed to have Essure implanted I truly did not know what I was signing up to endure for the next two and half years. Also, I had no idea that I when I agreed to have medical device implanted for birth control, I was also signing away my rights because of PMA. I am optimistic the ruling from Judge Padova will help our 28,000 members. I feel these cases will bring to light the issues we have found with Essure and the entire preemption process. We have been failed by the medical industry and the FDA. This judicial avenue will allow issues to be presented to a jury of our peers to judge, not those making profit. We are continuing working all avenues to make changes, including Congress. We are actively meeting with Representatives to discuss issues with Essure and the preemption process. Also, we are gaining more support for the E-Free Act (H.R. 3920) with each meeting. We will not stop working all avenues to ensure that all victims are protected and that changes are made in the approval process of medical devices.
Essure Problems Congressional Liaison
I have always been an unwavering, optimistic idealist. I grew up believing that government agencies, law enforcement and doctors held themselves to a higher standard than the average citizen. For me, these people were the royalty; I had them placed on a pedestal. This is a perception that I maintained into my 20s. When I began to learn that all people are fallible regardless of their position or status I was not jaded. I simply developed a greater level of respect for these professions and agencies that I had already held in such high regard. They went from being royalty to being superheroes of sorts.
In 2000 I volunteered to participate in a clinical trial which filled me with excitement. I was going to be part of a process that would help millions of women. It would make their life better and give them options that they did not have before. I believed whole heartedly in the clinical trial process just as I believed in our governmental and judicial processes. Just as I believed in medical facilities, doctors and nurses.
Back then I knew nothing illness, PMA, or political agendas fueled by money and power.
The FDA’s recent decision to allow Essure to remain on the market with a black box warning, a patient checklist and new studies would seem like a small step in the right direction but is it really? It is not nearly enough and it leaves so much room for error. Further studies conducted by Bayer will leave room for error by omission and skewed data. This is something I personally saw firsthand during the clinical trials. It has been brought to public attention that my clinical trial records were visibly altered but that was minor compared to what was never reported at all. A long list of new symptoms that I experienced after the implants were not documented at all, not once.
The FDA needs to act swiftly. So many other products and devices are pulled for much less and I do not understand where this weak approach to the safety of women comes from. I want to believe in the process again but, more importantly, I want to believe that citizen’s safety and wellbeing is the top priority of the FDA and that they will take the necessary steps to protect women.
Never in a million years would I have thought I would be involved in advocating for women's reproductive safety until I was affected myself and looking for help. That's when I realized how widespread it was around the world. Day in, day out we read in our group how someone is affected by Essure every hour, every minute, every second. Our group has grown in major strength because of the knowledge, love and support our group has and offers. We are happy and relieved at the same time, that the judge allowed the claims to go through. This will give the women a chance for a fair fight. The FDA took almost 6 months to only let us down by allowing the device to stay on the market. Despite, hearing and seeing many victims and families at the hearing talk about the physical and emotional harm they experienced.
After seeing how we were treated at the FDA meeting it made our fight that much stronger and that's why we now have Congress helping us, because we know Bayer and the FDA will not pull it off the market unless they are forced too. Its is our hope that other claims will get passed Preemption as well which will sooner or later force Essure sales to bottom out and lose its reputation of a safe and effective device. We are fighting so hard and full force to protect our daughters and the younger generation of ladies to follow behind us. Essure Problems group isn't going anywhere and won't stop until Essure is removed from the market and or PMA is lifted.
The facts, evidence and truth are available for the world to see. Hearing the news of the judge allowing the cases of truth and harm to go through in his courts, speaks to justice. By definition; justice is defined by moral principle as well as “what is just by law”. These two facts hold true in these cases. There is clear evidence that this Pre-empted medical device causes harm to women, husbands, children and families. A sterilization device should not destroy lives nor take away a woman’s civil rights as in the case of Essure. The literature and evidenced based research is pretty clear on foreign body reactions and yet, Bayer and the FDA with all its knowledgeable scientists dispute and ignore this. The statement “women should have choices” is true however; these choices need to be safe choices. Essure is just not a safe choice for permanent sterilization. Women all over the world may argue that they should be given the right to choose this method, what they don’t know is how harmful this choice could be. Removal of this device from the market will save the lives of many women for generations to come. If the FDA were doing its job and protecting women like they should be doing, there would not be support groups and advocacy groups fighting the CDRH, FDA and Pharmaceutical companies for reform. Harmful practices must be stopped and “we” advocates for women’s reproductive safety will not stop until reform is evident and in practice.
The recent decision by the FDA to allow Essure to remain on the market with additional warnings, a patient checklist and ordering another study to be done is disappointing but not unexpected. We have tried to work with the FDA and sadly we have learned that the FDA has little interest in real world patient experience. Instead the FDA prefers to rely on data that is collected and controlled by Bayer. The recent court cases that survived preemption are a testimony to the women who have suffered and fought to raise awareness to prevent other women from being harmed by Essure. The support and love these women have shown one another is absolutely amazing. For me personally I think this speaks volumes on how devastating Essure has been to many women. We will continue to raise awareness and fight to see that Essure is taken off the market.
When I signed my consent to get Essure, I was under the impression that it was a safe product. One that had gone through rigorous testing by the manufacturer for the FDA to grant its approval as a safe, implantable medical device. I had no idea that none of the side effects that I would be experiencing after I got Essure were even taken into consideration in the approval process for Essure. I thought I was the only one, dying a slow death after getting essure implanted in my body. It destroyed my quality of life. I looked to doctors, who had no answers and denied that this was the trigger. Finding others that had experienced what I had gone through, finding new resources and doctors, helped me to find help. Help in getting Essure removed from my body. The mission statement of the FDA reads as this: FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. They have failed to do this with Essure. Offering a black box warning and more clinical trials is not enough to protect others. Essure causes irreparable damage. No woman should ever have this happen to her. I will continue to fight against this until Essure is off the market and no product or device is granted PMA for reasons like this.