Essure Birth Control Under Fire

iStock_000013959692XSmallUPDATE (2/15/16) Elk & Elk is now actively pursuing legal action for victims of Essure. Call 1-800-ELK-OHIO for a free consultation.

Facing a wave of public criticism, Bayer has agreed to add warnings to the patient information booklet for Essure – a permanent birth control device consisting of coils inserted into a woman’s Fallopian tubes. The new language includes warnings of pelvic pain and device migration.

On the market since 2002, the device has been implanted in nearly 1 million women worldwide. Promoted by manufacturers as cheaper and less invasive than traditional tubal ligation, the Essure system has become a source of irritation for both Bayer and patients, with over 3,000 women speaking out about adverse reactions to the implants on social media sites.

According to news reports, a majority of the women are experiencing side effects from an allergy to nickel, which is a component of the coils. Originally, doctors were advised to test women for nickel allergies before implanting the Essure coils, but the manufacturer asked the FDA to remove that requirement a few years ago.

Other women complain of extreme bloating, skin rashes and headaches. Photos posted include broken coils that had been removed and X-rays of coils that perforated the fallopian tubes.

Reporting is crucial

Despite the growing anecdotal evidence regarding alleged risks associated with Essure, the FDA can only respond to official reports of serious adverse events. Even if you have spoken to your physician, it does not guarantee a report has been filed. If you wish to file a report, you can complete the paperwork yourself or ask for assistance from a friend, family member, or healthcare professional.

Adverse Events

According to the FDA, an adverse event is “any undesirable experience associated with the use of a medical product in a patient.” If an event is serious, it should be reported to the FDA. Examples of serious adverse events include, but are not limited to, death, life-threatening effects, hospitalization, disability or permanent damage, birth defects, and other important medical events.

For more information about reporting adverse events or to file a report online, visit the FDA’s MedWatch website.

You can also download instructions with the Consumer-Friendly Voluntary Reporting Form (PDF – 1.2MB).

 

NOTE: This blog was originally posted in November of 2013 and has been updated to include new information.

 

Source:

“Bayer changes Essure patient booklet to include health warnings on its birth control” by Lauren Gilger and Maria Tomasch, ABC, November 12, 2013.

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8 Replies to “Essure Birth Control Under Fire”

  1. I had a hysterectomy with essure removal on 9/26/2014. I had the essure implants since February 2011. I told the Dr at implanting that I have a nickel allergy. He told me there wasn’t enough nickel in them to cause problems. I trusted him and went ahead with it. Biggest mistake of my life.
    I have had rashes, bloating, depression, weight gain, the list goes on.
    My relationship with my boyfriend and family has suffered tremendously.
    What can I and other women who have suffered do?

    1. Angela,

      Elk Elk & Elk is now accepting Essure claims. Call us at 1-800-ELK-OHIO for a free consultation.

      We can empathize with your frustration. Unfortunately, Essure was approved by the FDA under what’s known as Premarket Approval (PMA) — the most stringent type of device marketing application required by the FDA.

      The problem for thousands of women just like you is that Federal Law preempts (overrules) PMA lawsuits based on state law claims, such as negligence or failure to warn.

      We wish you all the best,
      Your Friends at Elk & Elk

  2. I have had essure for 2 years. When I initially had a consultation I was told there were no side effects. Which is the reason I decided to go with the procedure. When I went to have it done there were complications and they couldn’t get one in and it caused severe pain. I then had to go to Christ hospital to have the other one put in under general anesthesia. I have had an horrible experience with these since day one. I since then have had severe abnormal bleeding, chronic pelvic pain, and now have to have surgery to remove my fallopian tubes and a possible hysterectomy. I am a mother of three and work full time. It’s going to be very difficult for me to have the down time for another procedure.

    1. Cassie,

      We are very sorry to hear about the complications you have experienced due to the Essure birth control system. Unfortunately, you are not alone. That’s why Elk & Elk is actively pursuing claims against the manufacturer.

      If you have questions about your legal rights, call 1-800-ELK-OHIO today.

      Best wishes,

      Your Friends at Elk & Elk

  3. I have had constant pain since I received the essure. The pain is getting worse and worse and I can’t get answers. I am scheduled for a historectomy on May 25th without getting clear answers. I’m on three different medicines to try to help with pain and it’s not helping.

  4. I had my tube tied using the Essure method may 8th, 2015 shortly following the procedure I started experiencing a lot of abdominal pain on December 4th 2015 I had a laparoscopic surgery to remove scar tissue caused from the previous procedure and on April 29th 2016 I still experiencing such severe abdominal pain I had to have a complete hysterectomy which has resulted in having to take hormonal pills and effects my life daily and all this occurred a month before I turned 30.

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