On September 24, an FDA advisory committee heard emotional testimony from women and medical experts across the country urging them to take the Essure contraceptive device off the market.
The Essure device went on the market in 2001, and through 2010 there were 660 reports to the FDA of unintended pregnancies in the United States. This was according to a statement released at the hearing by Bayer, which makes the device. But it wasn’t just the ineffectiveness of the device that truly drove the FDA to convene an advisory committee. Thousands of women have blamed Essure for a variety of complications, including pain, heavy bleeding, fatigue, hair loss and depression. Even more serious are allegations the device has caused perforations of fallopian tubes and possibly even death.
During the daylong testimony Panel members sharply questioned Bayer representatives, and the FDA over the handling of the device. Most notable Dr. Peter Schalock, a dermatologist at Massachusetts General Hospital, asked Bayer point blank if Bayer or the FDA had ever even tested for nickel allergies – the device is part nickel – asking if data even existed or Bayer had simply made it up.
The strongest testimony of the day came from Gabriella Avina, had taken part in the original clinical trials and worked for Bayer when Essure first came on the market, explaining the device to women. Avina testified, “I am here today, almost 13-plus years later, to say I was wrong. Time has changed my thoughts, beliefs and, most importantly, my health.” She then went on to testify about how badly health deteriorated after she had the device implanted. Avina described how she was diagnosed with a thyroid disorder, myasthenia gravis, and celiac disease which all required multiple hospitalizations and chemotherapy.
The panel delivered its sharpest criticism at Bayer, questioning why the company has been so remiss at collecting data about the Essure device, even after 15,000 “adverse events” were reported in the United States.
Essure was approved under the FDA fast-track review process, and after this hearing stands to join a growing list of failed medical devices approved under the same process.
This failure of corporate industry and the FDA to protect women’s health comes on the heels of the public health disaster involving the marketing of transvaginal mesh products.
There are now over 80,000 federal lawsuits in the U.S. against Ethicon, Boston Scientific, American Medical Systems, C.R. Bard, Coloplast, and Cook for complications from transvaginally implanted mesh devices.
It is clear that more federal regulation is needed to protect women from unsafe medical products. This, unfortunately, is unlikely to occur because of the number of politicians who campaign on smaller more limited government and are supported by money from the pharmaceutical industry. To them any regulation for health or safety is called “a job killing regulation”. This campaign slogan may sound good to some but the ultimate effect is to allow industry to put profits ahead of safety and to cause horrible suffering by consumers injured by dangerous products.
Admitted to practice law in all federal multidistrict litigation courts, the California State Bar and the Florida Bar. His philosophy is to provide aggressive, quality representations and seek fair compensation for individuals and their families who have suffered injury, death, or sexual abuse.
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So who is going to pay to save all these women's lives now??!!! Including my own. There should be some kind of retribution for the lives they stole and the ones they changed!
I am a survivor of ESSURE. I have know nickel allergies, yet was never told. I lived in my own hell for almost 9 years before I understood what was going on. MSDS state PET fibers are not for human implantation, yet ESSURE contains them. FDA placed a class III PMA on this product, yet class III states for live-saving devices. Proof shows this is inaccurate. Please support Mike Fitzpatrick (PA) on our E-Free Act to revoke PMA. With the revocation, women can can finally have a voice louder than we have now. I want Bayer to see my face and know my name. 22,700 other women want the same thing. Class III is the wrong classification for this product since its been proven to be far from life-saving.
I have had the essure in 2009 have had pain in my rt side continuously still got pregnant w the device in as well my child is now 5yrs old to this day i still have issues with the device sometimes doubling over had to have my gall bladder removed last aug 2015 !ue to a bacterial infection and still being treated
Strange, I thought Bayer had stopped using women's bodies as guinea pigs for horrific medical experimentation and torture after treating Jewish women in concentration camps during WWII. Now that I have the evil Essure coils in my body, I am devastated to learn the hard way, it's simply not true. Shame on Bayer for putting profits over people (again). The clinical data on Essure was falsified to fast track PMA by the (also corrupt) FDA. The proof is out there. Why are they still on the market?!
I got Essure in 2006 at the point when I had been the healthiest ever in my life. In fact, my health was the very reason my Gyn strongly encouraged me to get it. Since this time I have developed an extreme decline on my GI system, reproductive system and my Immune system has been dangerously attacked. I can no longer use everyday cleaning chemicals, sunscreens, bug repellents or take traditional over the counter or prescription drugs without risking an anaphylactic reaction requiring medical intervention. I have had to undergo multiple tests, and am now waiting to undergo my scheduled hysterectomy- ALL as a result of a medical device I was told was safe to be on the market; one that has cost me and continues to cost me thousands of dollars to attempt to get my life back to, what I pray will be, normal again.
Great article! Thank you for taking on this issue, as many are still afraid to confront big pharma and state what all of us Essure sufferers know: for them, it's profits before people. I suffer greatly because of Essure, and as a single mother, I cannot have it removed, because there is no one to fill in at home during the 6-8 week down time after removal. It is the cruelest of catch 22's. I can honestly say that getting Essure was the biggest mistake I've ever made.
Getting Essure is the worst mistake I have ever made. The product is not safe, nor is it effective. I was confirmed blocked, at 3 months, after implantation. Five years later, a coil perforated my left tube and migrated to my uterus. I am currently pregnant, and expecting a little girl March 1, 2016. Before considering this product, please join the Essure Problems page on facebook. Today alone (10/13/2015) there are at least 10 members, from this page, that are having surgery to remove this horrible device. Everyday day there are women having these removal surgeries!
I am writing you because I was poisoned and mislead by the Essure Birth Control Device. In 2010 I was 41 and my husband and I were done having children. I was the only one with Health Insurance at the time which I purchased through the Syracuse Chamber of Commerce because I am a self employed Real Estate Agent. I learned about this permanent procedure which was non surgical and it sounded great. No surgery, no down time and a 30 dollar co pay. I was given a sedative and my daughter who was home from college drove to a surgery center where I met my doctor and went in and placed the coils 2, one in each fallopian tube. I watched him do it via a video screen. It took 10 to 15 minutes to place them. I cramped and had mild pain which was expected. It passed after a few days. I went back 3 months later for my dye test to make sure both tubes were blocked like required. I then noticed every month during my cycle I would have terrible cramps and pain also if I coughed I could feel them poke but figured it was normal. I couldn't really remember what normal cycle was after having 4 children and always being on birth control pills. I also had a iud removed that day which was also recalled and it had grown in my cervix so he took that out before he put the essure in. In the summer of 2010 I started having trouble with my gallbladder and it sort of felt like kidney stones or something so I went and had everything checked and was told it was fine and I had GERD. I had all sorts of things happening to me throughout the last 5 years from severe depression, exhaustion, weight gain where I looked 5 months pregnant, tasted metal in my mouth, my teeth were breaking and I was getting cavities and such, hair falling out, nausea everyday, migraine headaches which lasted for weeks, then last year I was having those pains again and thought gallbladder. I just figured I was getting older and things were just breaking down. I ended up being rushed to the hospital in a fetal position I couldn't keep anything down not even water so they did all types of tests and scans and blood work. They said I was fine but my white blood count was high. They sent me to a Gastronologist and they ended up putting a scope down me and some damage was done to my lining but it was still just GERD. I even had the kidney scan done as well. Nothing ??? It wasn't until my close friend was sick and had surgery that I found out it could be Essure. Her essure device broke in 3 pieces and was logged in her uterus and back and tore her apart. She said you have everything I have had and told me about the Essure Problems Facebook page. I started reading it and noticed I was not alone and the same symptoms. I never imagined that it was my Essure causing all of this who would ever think a birth control device would do this to us. Anyway I was having constant pain in my right side and asked my friend a million questions and went to her doctor. He did a xray scan and my essure was in my tubes and in place then he did a sonogram as well. I was scheduled for a hysterectomy and had the procedure 2 weeks and 2 days ago September 28th and in the meantime I watched the FDA hearing on this device on the 24th and was furious especially when the woman on the panel was laughing I felt like implanting her with it. Anyway they did not recall it and the company Bayer is protected because of it being a class 3 device. Bayer had no proof, no evidence, no nothing and really no stats and woman and doctors who were a part of the initial first tests and device spoke out against Essure. When I went for surgery I had been on pain killers for almost a month it was that bad, my doctor told my husband he could not see what this did to me fully until he operated and was surprised I only complained about my right side and not my left as well because the left was worse. The essure device perforated both of my Fallopian tubes. I have my follow up tomorrow and can't wait to see the pictures and talk with my doctor about what this did to my body and the last 5 years of my life, emotionally, financially and physically. I feel robbed and lied to and no one is accountable for this. It has been e hell and I am emailing you to ask you to help us woman. Mike Fitzpaterick is sponsoring a bill to get this changed and off the market. Companies should not be protected when reports were falsified and proper tests and such were not done. This device contains Nickel and PET fibers which both should never be put in a human body on the information I have read and they are doing both. No one knows our long term effects but I know since this has been properly removed the pain is gone, the taste of metal is gone, my stomach looks 2 months pregnant instead of 5 months and I feel so much better. I am trying to recover still but this has damaged me in so many ways and hopefully I won't end up with future problems from 5 years of exposure. Please get this off the market and hold these people accountable. Also please take the time to look at the Facebook page Essure Problems over 23000 woman and you will see what this is doing and doctors are pushing this product because they make a lot of money. Feel free to contact me or call me and please help us all.
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