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.
READ MORE ESSURE LEGAL NEWS
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.
READER COMMENTS
Sue Anna Garlock
on
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.
Melissa
on
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.
Victoria Ellerbe
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Elizabeth Middlebrook
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Volana Milan
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