Federal health regulators have essentially rejected a citizen petition calling for a recall of the Essure birth control implant, despite numerous complaints from women about damaging complications and side effects.
The FDA issued a letter (PDF) on March 26, responding to a petition signed by more than 2,100 women and indicating that the agency will not force an Essure recall and that it is closing the petition.
The original petition was reportedly filed incorrectly, according to the FDA, which indicated that since it was a trade complaint, the petition will be forwarded to the Office of Compliance within the Center for Devices and Radiological Health (CDRH). The agency then stated that the petition was considered closed.
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Learn MoreEssure is a birth control implant offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
In January, a citizen petition was filed with the FDA regarding reports of severe and debilitating problems from Essure implants, including extreme abdominal pain, excessive bleeding and internal organ injuries.
The transfer to the office of compliance means that the FDA is rejecting and closing the petition. However, the agency could still determine that regulatory action is needed against Bayer over the Essure complaints.
According to the letter, the petition, which called for an Essure recall, claimed that Bayer and the Essure’s original creators had committed fraud in respect to the clinical trials over the device and that they had violated the terms of Essure premarket approval.
“The Office of Compliance will enter the information into the Allegation of Regulatory Misconduct system, send you an acknowledgement, review the information and investigate the complaint,” the response letter indicates. “The Office of Compliance will pursue actions as deemed necessary.”
Essure Complications
Although the procedure has become increasingly popular, the FDA has received hundreds of adverse event reports over the past year involving side effects of Essure birth control, including instances where women had to undergo a hysterectomy due to complications that may have been experienced.
Concerns over the birth control implant gained substantial media attention over the summer, following Congressional testimony involving an Essure injury during a briefing by the National Center for Health Research that called for legislation to improve the FDA approval process.
Bayer, which bought the original company that designed the Essure implant and now markets the device worldwide, has downplayed the complaints, maintaining that there are relatively few cases out of the Essure implants used worldwide.
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11 Comments
BJSeptember 20, 2016 at 4:18 pm
The back pain is caused from the coils causing your uterus to contract which causes back labor pains as the muscles are pulled. Wish the judge could feel what that is like for one day and then think about having it for years! Took me a while to figure it out. Mel... I thought there was something wrong with my bones too, it's the coils. If they're in you get them out!!! I've been through hell, it o[Show More]The back pain is caused from the coils causing your uterus to contract which causes back labor pains as the muscles are pulled. Wish the judge could feel what that is like for one day and then think about having it for years! Took me a while to figure it out. Mel... I thought there was something wrong with my bones too, it's the coils. If they're in you get them out!!! I've been through hell, it only gets worse.
KristinMarch 22, 2016 at 4:35 am
Essure is marketing to women as a nonsurgical alternative to traditional tubal ligation. It claims to be made of safe materials, inserted in your physicians office in 10 minutes, and 99% effective. Upon further review and statements released by Bayer's own representative these are not only untrue but misleading. Essure is a surgical procedure. It is made of nickel, PET fibers and known carcinoge[Show More]Essure is marketing to women as a nonsurgical alternative to traditional tubal ligation. It claims to be made of safe materials, inserted in your physicians office in 10 minutes, and 99% effective. Upon further review and statements released by Bayer's own representative these are not only untrue but misleading. Essure is a surgical procedure. It is made of nickel, PET fibers and known carcinogenic agents. It has a failure rate of 9.6%, higher then any other "permanent sterilization." This false advertising led myself and many other women to choose this over other options. I feel action should be taken against Bayer.
amandaOctober 12, 2015 at 12:56 am
I had essure done in 2012..biggest regret of my life that i have ever made..once the coils was inserted months later i had major headaches,back pain,serve cramps,and most of all it hurt during sex..im 33years old and just had a hysterectomy done last week because one of the coils was imbued in my left overy and caused the overy to rotten inside my body..i dont give a two cents who thinks what im a[Show More]I had essure done in 2012..biggest regret of my life that i have ever made..once the coils was inserted months later i had major headaches,back pain,serve cramps,and most of all it hurt during sex..im 33years old and just had a hysterectomy done last week because one of the coils was imbued in my left overy and caused the overy to rotten inside my body..i dont give a two cents who thinks what im about to say..essure is not suppose to make a woman go threw Hell,and most of all essure is the devil implants!!!Take this crap and shove it who ever made them..
MelOctober 1, 2015 at 2:33 pm
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 researc[Show More]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. Bullshit. 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 shits about women, when what they are worried about is their pockets.
LatinaJuly 27, 2015 at 2:28 pm
Hello I am another victim of the essure my coil is punctured in my uterus and other the source is unknown leaving me in permanent discomfort and pain. I have been pregnant twice (high risk) very stressful wondering if your child or yourself would even make it with a device that is suppose to be permanent. I want to know how to go about signing the petition and what can be done. It's not fair peopl[Show More]Hello I am another victim of the essure my coil is punctured in my uterus and other the source is unknown leaving me in permanent discomfort and pain. I have been pregnant twice (high risk) very stressful wondering if your child or yourself would even make it with a device that is suppose to be permanent. I want to know how to go about signing the petition and what can be done. It's not fair people have to die and lives have to be ruined from your product nor that a permanent procedure can only be reversed by losing her womanhood or other complicated life threating surgeries. Like everyone else I just want justice
hayleyJune 24, 2015 at 3:58 pm
I hope this does get recalled and we get justice for this horrific procedure and the result that cone after...it was the worst decision of my.life...almost worst then giving birth it was torture. I am now hav I.g to go back and forth to the on gun with symptoms that's have yet to be explained. I'm am hav I.g to now take birth control even after this procedure to "control" my symptoms but I feel it[Show More]I hope this does get recalled and we get justice for this horrific procedure and the result that cone after...it was the worst decision of my.life...almost worst then giving birth it was torture. I am now hav I.g to go back and forth to the on gun with symptoms that's have yet to be explained. I'm am hav I.g to now take birth control even after this procedure to "control" my symptoms but I feel it's ridiculous...that's y I got my tubes tied otherwise I would have just started birth control from the beginning. I would love to hear from any women on how I can join a petition because I want answers and justice!!!
DanielleJune 7, 2015 at 3:13 am
Ok I have not yet got the essure. I'm suppose to get it next month July 2015 and I keep reading comments like this and it almost makes me not want to get it but still an in favor of getting it done.. Can I get more advice about this??? Please...
VeronicaMay 11, 2015 at 1:05 pm
I had the procedure done in 2013, and after it I never had a period again,went to see the doctor about it and was told I was starting menopause, I complained about abdominal pain and severe lower back pain, and insisted it had to be the procedure, I was told it had nothing to do with it and the dr office just stopped returning my phone calls, I've been in and out of the Er with the same problems a[Show More]I had the procedure done in 2013, and after it I never had a period again,went to see the doctor about it and was told I was starting menopause, I complained about abdominal pain and severe lower back pain, and insisted it had to be the procedure, I was told it had nothing to do with it and the dr office just stopped returning my phone calls, I've been in and out of the Er with the same problems and no one can tell me anything other then they can't find anything, I have no energy, constant abdomen pain, back pain, headaches, heart palpitations, constant hot flashes, Constantly feels like my organs are on fire. I regret ever getting the essure, it has ruined my life.
DebApril 1, 2015 at 6:35 pm
I am disgusted.....after a year of battling vaginal cancer and STILL having essure emmbedded in my uterus, I am finally getting my surgery next month . How many more women have to suffer? I wonder if Bayer Execs would allow this product implanted in their loved ones to then have their lives altered due to pain and suffering?
KatherineApril 1, 2015 at 3:25 am
How many women have to die or have their organs ripped apart before admit there is a huge problem? My Name is Katherine Graham and I just had my hysterectomy on March 5th at the age of 35 from your devil coils after suffering many symptoms and a debilitated state and I had to leave my job and was unable to care for my children! A career I worked hard for! So thanks for ruining my life and then thi[Show More]How many women have to die or have their organs ripped apart before admit there is a huge problem? My Name is Katherine Graham and I just had my hysterectomy on March 5th at the age of 35 from your devil coils after suffering many symptoms and a debilitated state and I had to leave my job and was unable to care for my children! A career I worked hard for! So thanks for ruining my life and then this! It's dirty! This country has gone to hell because of companies like Bayer! You are horrible people!
AliciaApril 1, 2015 at 3:10 am
i have had a baby and several surgeries and more to follow. i want some justice for my severe pain and suffering