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Essure Not So Sure

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Birmingham, ALDespite the FDA having received more than 5,000 adverse event reports regarding Essure, the birth control device is still on the market. Now hundreds of Essure victims are taking action to ensure that Essure is taken off the market.

Essure side effects range from ectopic pregnancy to uterine perforation to death. Some women reportedly had a hysterectomy to remove Essure - a permanent sterilization device.

Since Conceptus Inc. (a subsidiary of Bayer Health Care) introduced Essure in 2002, citizen petitions have urged the FDA to order an Essure recall. Besides severe Essure side effects, the petition claims that Conceptus falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device’s safety and efficacy, and used defective materials in manufacturing Essure.

Essure was FDA-approved with a list of conditions, one of which was that Bayer report all adverse events. But “troubling long-term data on women” using [Essure], was published on April 24 after an eight-year delay, according to the New York Times (May 2015). Since the FDA fast-tracked Essure to market, 16,047 complaints were filed between 2011 and 2013.

Essure lawsuits

Because Essure has undergone scientific and regulatory review, federal law protects Bayer against liability, giving the manufacturer a “shield of protection” against lawsuits. However, several product liability lawsuits have been filed in the U.S. District Court, Eastern District of Pennsylvania, seeking to remove this shield from Bayer and Essure liability lawsuits. These lawsuits claim that Conceptus violated the conditions of its premarket approval and should no longer receive that protected status.

The first Essure lawsuit, filed in July 2014 in Philadelphia civil court, accused the Essure maker of “intentionally misleading women implanted with Essure and violating the conditions upon which the company received premarket approval” from the FDA. Plaintiff Heather Walsh said that Essure “should never have been marketed or sold,” according to court documents

If the judge agrees with plaintiffs that Bayer committed fraud, it will likely open the floodgates to Essure lawsuits (Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384, U.S. District Court, Eastern District of Pennsylvania).

What you can do to take Essure off the market

Meanwhile, if you have been injured by Essure, you can help (besides filing an Essure claim with an attorney) take this device off the market.

In a press release (June 2015), Dr. Francois Blaudeau, a practicing obstetrician/gynecologist, asked women and the public who have been injured by Essure to submit their own experiences to an FDA meeting that will be held September 24, 2015.

(The FDA meeting is an opportunity for anyone to provide advice and recommendations to the Agency on FDA’s regulatory issue. An advisory committee at the meeting will discuss the risks and benefits of Essure for permanent female sterilization. After evaluating data regarding adverse events, the committee will provide recommendations regarding appropriate device use, product labeling, and potential need for additional postmarket clinical studies. The public will have all background information and data from the FDA no later than two days before the meeting.)

This meeting is crucial to determine Essure’s fate. As well, some women who call themselves “E sisters” are Essure victims who have formed a group with the intention of getting Essure off the market. And even Erin Brockovich, the famous activist, has launched a website urging the FDA to remove Essure from the market.

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READER COMMENTS

Posted by

on
Please help spread the word and get our voices heard!!! I've lived in pain for almost 2 years now. Many of the issues I've been experiencing I kept to myself because I thought I was going crazy. Me, a basically healthy, thirty-something woman, couldn't possibly have so many health issues. Until recently, I was afraid that no one would believe me, that I was exaggerating, or think I was a hypochondriac. There were some problems that I couldn't ignore and I did tell my doctor or ended up in the ER. I have experienced depression, anxiety, severe fatigue, hair loss, siezures, tremors, brain shocks, severe cramps, back pain, joint pain, and general body aches and pains all over. I had to have my gallbladder removed, and I have had colitis, and other stomach and intestinal problems. I have also experienced many other issues, the list is as long as this post, and the doctors either had no known cause, or it was considered to be related to my previous diagnosis of hypothyroidism (even though in the 15 years I've had thyroid issues, I never experienced these symptoms before). Recently, a friend heard and read about several women who have been experiencing similar issues and found that the cause was from the Essure device implantation. She immediately thought of me and my health issues over the last almost 2 years believing that my health problems could all be caused by the Essure device. She sent me several links so I could research this possibility. It never dawned on me that the Essure sterilization procedure I had was causing all my misery. Now that I have done my research, I believe, without a doubt, that my drastically declined health is being caused by the coils that are inside of me. The coils are made with a titanium-nickel alloy and can cause adverse effects to those who have an allergy or sensitivity to nickel. I was never asked if I was allergic to or had a sensitivity to nickel before having the procedure done. And honestly, if they had asked me, my answer would have been, "Not that I know or am aware of." Why don't they automatically test everyone who is getting the implants for a nickel allergy before completing the procedure if they know that it will cause problems for those who are allergic??? I now know that I am allergic to nickel, and many of my symptoms are being caused from the nickel in the coils. The other problems I have that aren't related to nickel allergies, are believed to be from the PET fibers that are inside the coils. The purpose of the PET fibers are to create an irritation that makes the body develop scar tissue around the coils in the fallopian tubes, which keeps the males little swimmers from reaching the females eggs. These PET fibers aren't staying in the coils as intended. After a while, the PET fibers are separating from the coils and being absorbed by the body and migrating to other parts of the body. So if the PET fibers are creating scar tissue in the fallopian tubes, what do you think is going to happen to the organs and tissues that they eventually migrate to in other parts of the body? Common sense tells me that they are going to also irritate the organs and tissues they migrate to and cause adverse reactions. In fact, its these fibers that are causing many others to develop autoimmune disorders, like thyroid problems and Rheumatoid Arthritis. The body's immune systems natural reaction is to attack foreign objects, since these fibers are migrating throughout the body, the immune system thinks its under attack, so naturally it fights back, but because the fibers don't go away, it sends the immune system into overdrive and eventually causes it to stop working as it should, and this is what causes an autoimmune disorder. Since I actually already have 2 autoimmune disorders, hypothyroidism and RA, my immune system is already in overdrive, now due to the irritation created by the PET fibers, my body's immune system is in hyperdrive. This is causing the disorders normal symptoms that are already present to be intensified and causing other symptoms that can occur, but previously didn't, to develop. These two very small details, the nickel allergy, and PET fibers, that were not previously mentioned in the products literature or explained to me by medical professionals, is the cause of all of my medical problems, pain, and misery for almost 2 years. Now all I want is to have these things taken out of me! But there is no guarantee that removal will make me better, in fact, it could cause more problems. Even if the removal is successful, and helps elevate some of my symptoms, I will more than likely have to have a complete hysterectomy, and go through menopause about 15 years early. And there's no guarantee that they will be able to find and remove all the PET fibers that have relocated to other parts of my body. I am sharing my story because I do not want anyone else to experience the pain and misery I have endured, and want to let others out there who have these same or other problems know that they are not alone. Before having this procedure done, please do your research first, don't do it just because your doctor recommends it, ask questions and demand the truth. If I had known the above risks associated with this, I wouldn't have chose this option. If you already have this device implanted, and are experiencing unexplained health issues, more than likely they can be explained now and that explanation is Essure! If you are going to have the removal surgery, please research the risks involved with this procedure as well. Educate yourself, ask lots of questions and make sure you choose someone who has been trained in the removal procedure.
I really want my life back. I want to be the best mom, wife, daughter, ect again. I'm tired of being tired and letting my family and friends down due to my health impairing me and keeping me from living the life I once did. Thank you for reading and I hope my story, and this information helps others make an educated decision when considering this method of sterilization and/or removal of this device. Please feel free to share my story with others as well.

Posted by

on
Let me preface this story by saying that I am, hands down, THE healthiest person I know...ask anyone at my gym, my job, or ask my friends and family. I eat clean, exercise, intensely, daily, sleep 8 hours a night and don't take any medication. I'm now 42. I had Essure implanted in September 2012. Never wanted kids, didn't want hormones running rampant in my body, so this seemed, after much research, the least invasive, safest, easiest alternative to hormones or tubal ligation.

Year 1: felt like I had been hit by a bus, DAILY. Joint pain, flu-like symptoms. I kept saying "my bones hurt" because that was literally the only way I could describe the pain. I felt like I'd been poisoned...like there was a heavy metal coursing through my veins. Fatigue, lethargy, I could hardly drag myself out of bed. Spent countless days and nights sobbing and wondering what was wrong with me. I finally decided I had either fibromyalgia or possibly something like leukemia. I know now that my body was reacting to the implants, most likely the nickel and that I was in fact fighting my body being poisoned from the inside.

Well, that eventually ended. Then, for the last year, I've had excruciating pain in my sides/abdomen. Thought it was kidney stones, possibly. Now, I don't have insurance, so everything is out of pocket for me. I've had labor-pain type menstrual cramps. I don't EVER stop bleeding. All month, blood. Guess Essure does the tricl because sex has become so painful over the last year that I just can't handle it anymore. Not to mention, each time I have sex or squat heavy at the gym, or run sprints (anything that involves the waits/hips area), I bleed afterward. I bleed during sex, after sex, and for days following sex. My vaginal discharge smells different than it has my whole life, and it's not a pleasant smell. I have stabbing pains in my abdomen...both sides. I have intermittent sever gas and bloating of the abdomen, from my rib cage down. The constant pain in my sides and bleeding and no sex I decided I'd just have to live with. I went to the gyno who inserted the Essure and she said all of the above are symptoms related to my age...that it's "that time." When I told her I though it was the Essure she said no. She said the only way I could get rid of the Essure was to have a full hysterectomy. Bullsh*t. I went to a second gyno that a friend recommended and he said that the symptoms were definitely a result of the Essure (he ordered an x-ray that showed the implant were exactly in the correct position, so we know it's not from breaking/movement) and that he could remove them laproscopically, but he'd never done that before. When I couldn't get a price quote, I denied that surgery. Very scary. So, I've been doing research since on doctors who perform Essure removals (all are at IVF clinics). Three days ago I finally bit the bullet and scheduled my Essure removal with NCCRM in Cary, NC. I will be paying $4,280 out of my own pocket for removal and missing countless days of work (for which I do NOT get paid). That's how desperate I am to get these evil things out of me and feel back to normal.
Over the past three years, I've spent over $8,000 trying to figure out what's wrong with me and to get the Essure implants removed. Although nobody can "prove" that the Essure resulted in my slew of symptoms, I knew intuitively that there was no other explanation. After finding this site, and reading that other women had the same horrible symptoms, I can confirm that I'm not crazy after all. It;s not all in my head...it's all in my fallopian tubes. I am counting the days til the surgery, although I'm terrified of the general anesthesia and recovery time because I take excellent care of myself and never thought I'd be enduring this. I hope this helps another woman struggling out there understand that she is not crazy, not alone and that we just can't trust the collusion of government and big pharma to give two sh*ts about women, when what they are worried about is their pockets.

Posted by

on
I have the Essure implanted in june 2015. i have abnormal pains for a month. I praying for all woman, that soon they will take essure off the market..

Posted by

on
I had Essure implanted in December of 2011 and after 2 months I had such sharp stabbing pains in my abdominal and pelvic area. I went to the doctor who implanted them and he found nothing wrong. Then he tells me to see a chiropractor because maybe it was myofascial pain. I go see a chiropractor for several visits and I still had pain. I've visited gynecologist after gynecologist after gynecologist. They can't figure out what's wrong with me. I think I'm pretty much thought of as a lunatic to these doctors. All I know is that I was fine before essure. I had no pelvic pains, no abdominal pains, no hair loss, no fatigue, no backaches, no headaches, no low WBC count, no abnormal bruising. And now I have all of the above every day of my life for 4 years! I think this is more than just a coincidence. This product has ruined my life. PLEASE take these things off the market! So many lives have been ruined!

Posted by

on
I had the Essure procedure done in 2008. After 7 months I begin experiencing frequent pain in my lower abdomen and groin area. I also started having extremely heavy periods that last for up to 12 days. In addition, I begin consistently having unexplained backaches, headaches and hip pain. I've had numerous doctor's visits and I believe the pains are a direct result of the Essure implants. Unfortunantly, I am not financially able to have the reversal surgery. But, I am saving so I can have them removed as soon as possible.

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