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Essure Birth Control Complications Experienced By Women: Reports

  • Written by: Martha Garcia
  • 7 Comments

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A number of women throughout the United States are reporting serious and potentially life-threatening health complications from Essure, a permanent form of birth control that has been believed to be fairly safe.

Essure birth control is a transcervical sterilization procedure, which is marketed as a less expensive, easier and safer alternative to tubal ligation surgery. However, hundreds of women are reporting severe Essure side effects following the procedure, causing many to opt for a hysterectomy.

The FDA has logged more than 850 reports of adverse side effects since 2004, which suggests that thousands of problems have been experienced, since it is widely acknowledged that only about 1% to 10% of all adverse events are ever reported to the FDA.

Among reports submitted to the federal regulatory agency are more than 150 Essure complications involving the device moving and puncturing fallopian tubes or the uterus, with nearly 100 women requiring hysterectomies to remove Essure birth control following severe complications. In addition, at least 150 reports have been filed involving doctors complaining of the device breaking during insertion and numerous other problems with allergic reactions and side effects.

Following increasing concerns, the FDA posted new information to their website on October 18, outlining the results of their own investigation into the Essure problems, including a review of a five-year post-approval study, complaints through the MedWatch Adverse Event Reporting System and web-based testimonials.

The FDA has acknowledged the complications experienced by a number of women, but indicates that many were seen in clinical trials and are addressed on the product’s labeling, such as pain. However, the agency did note that some of the complaints, included depression, extreme fatigue, and weight gain, were not seen during clinical trials.

“We evaluated the available clinical literature to determine what long-term complications may be associated with Essure more than five years after placement, because the post-approval study only evaluated safety and effectiveness up to five years,” the FDA review states. “To date, we have found no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement.”

Essure birth control was first approved by the FDA in 2002. It was originally designed and manufactured by Conceptus, before recently acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus.

The birth control implant is 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 recent months, increased media attention has been focused on reported Essure problems experienced by some women, including extreme abdominal pain, excess bleeding, rashes and bloating, and having internal organs removed as a result of side effects. Some women report pieces of the device have remained lodged in the uterus following removal of Essure.

Many women have taken to social media and the internet to share and log their complaints. Some describe the pain as similar to having “daily period cramps” and others report the pain is as severe as “contractions of labor pains” where physical movement often makes the pain worsen.

The manufacturers of Essure have cited clinical studies focused on the safety of the procedure. The FDA has indicated that any women who have experienced Essure complications should submit a report to its MedWatch adverse event reporting program.

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Image via: Art Konovalov / Shutterstock.com

7 comments

  1. Brenda Reply

    I have had the Essure and shortly after the procedure I had experienced nothing but pure lower abdominal pain like knives stabbing me in the exact spots the coils were. The pain was so bad I gad to have them surgically removed which required my fullopian tubes to also be removed. This has been very costly. Since my tubes and coils have been removed I have still been experiencing horrible side effects physically and mentally. Still going to the doctor for help for the pain. Regret, regret, regret Essure.

  2. Heidi Reply

    I had essure put in Aug 23 2010. I have cramping heavy menstrual cycle irregular cycle irregular.passing clots back pain hot flashes fatigue sharp pains in my left side. I was tested to see if I was going into menopause I was told no. I asked my obgyn if my problems are from theeeessure I was told no. No I’m reading this and thinking I’m right. There are days I can’t get up I m in horrible pain and tired. I want theses out and don’t recommended them to anyone.

  3. Kemicia Reply

    I had the procedure done 2 years ago and now I regret it. After not having a normal menstrual cycle for 9 months + I went to my doctor and was diagnosed with Polycystic Ovarian Syndrome which leads to diabetes, weight gain, and irregular menstrual cycle. And yes I’m now newly diagnose insulin resistance patient. I am facing bad news every doctor visit and regret making a bad responsible decision.

  4. Jenn Reply

    I had the Essure procedure done in March 2014 and I have expierinced menstraul like cramps on both sides of where the coils were placed. I am just assuming that this is the tubes growing in or around the coils. I had my HSG test today and sad to report that only one of my tubes is blocked so far at this point. I was hoping for a better outcome and hopefully the other tube will continue to grow around the coil. The test was uncomfortable and I would rather not take it again!

  5. Angelina Reply

    I got Essure in August 2013, at the same time I delivered my daughter by c-section. I have experienced no major problems. I do get some minor twinges that correspond with my monthly ovulation, but the side effects of Essure for me pale in comparison to what I’ve experienced with IUD’s and hormone based methods. I’m happy with Essure.

  6. Elizabeth Reply

    I have had the essure since 2010 I was not told of any of the side effects that it could cause. It took one of my tubes 6months to block. Now I have extreme pain on my left side, have headaches worse than ever and mood swings more now than I have had before. I have been to the er so many times for the pain to the point where they have to take me straight back and start IV pain meds just to get the pain down so I can talk to the doctor. Then its a ct, a ultra sound and blood work every time. It is not worth getting.

  7. Jeannie Reply

    I had the Essure in 2008 and had nothing’s but problems ever since. Bleeding all the time or whenever I have intercourse. I have pain like someone’s stabbing me with a knife during intercourse in those areas. The pain in the exact areas where they are aches like severe cramping and sensitive to touch for several days after that. It has caused major issues in my everyday life. I have talked to my primary doctor and Gynacologist several times about this. They have checked the areas with ultrasounds and said everything else looks super healthy it has to be the Essure. The surgery to have hem removed is extremely expensive and I was told hard to find a doctor who knows how to do it.

    Jeannie

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