Essure, a permanent sterilization device made by Bayer, has been linked to thousands of reports of chronic pain, allergic reactions, organ perforation, and more. Erin Brokovich, the famed consumer advocate, is leading a campaign to get Essure off the market.
Need a Texas Essure Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Essure Lawsuit Information
One of the first Essure lawsuits was filed in California in November 2015. The lawsuit (PDF) was filed by a woman who experienced chronic pain, bleeding, and other side effects from Essure. Click here to read more.
In July 2016, lawyers representing over 1,000 women in 30 Essure lawsuits asked judges to create a Multi-District Litigation (MDL) to centralize the cases in one federal court in Pennsylvania. In August 2016, a single lawsuit was filed in Illinois by a group of 98 women who were injured by Essure.
Bayer claims it is immune from lawsuits due to a loophole in the way Essure was approved. This immunity has been challenged by lawyers and consumer advocates like Erin Brockovich. The litigation has been steadily moving forward since late 2015.
Essure Black Box Warning Label
In February 2016, the FDA ordered Bayer to conduct new clinical trials and update the label on Essure to include a “Black Box” warning about severe, debilitating side effects. The FDA also required new safety studies to better understand the risks of Essure.
On October 31, 2016, the FDA finalized the following “Black Box” warning for Essure:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.”
What is Essure?
Essure is a non-surgical device that is used for permanent sterilization of women. It consists of a nickel-titanium metal coil and a stainless-steel inner coil wrapped in polyethylene terephthalate (PET) fibers.
How Does Essure Work?
Essure is implanted through the vagina into the fallopian tubes. Once in place, it causes a low-level inflammatory reaction. Over several months, fibrous scar tissue grows around Essure and blocks the fallopian tubes, preventing pregnancy.
Side Effects of Essure
The most commonly-reported Essure side effects in the first year of treatment were back pain (9%), abdominal pain/cramps (3.8%), and painful sexual intercourse (3.6%). The serious side effects include:
- Migration of device outside of fallopian tubes
- Perforation of fallopian tubes, uterus, or organs
- Ectopic pregnancy
- Unwanted pregnancy
- Allergic reaction / hypersensitivity
- Fractured device
Study Links Essure and 10X Risk of Surgery
Women who get Essure are 10X more likely to need follow-up surgery compared to women who undergo traditional “tube tying” procedures, according to a study published in the British Medical Journal.
Only 0.2% of women who got their tubes tied needed surgery, compared to 2.4% of essure patients. Researchers called the results “a serious safety concern.” Conclusions were based on data from over 52,000 women in New York who were sterilized between 2005-2013. Click here to read more
One woman told ABC News:
“I felt like a shark was on the side of my body and wouldn’t let go. My whole body started to change. … I was itchy, my arms were tingling and my legs were tingling. … I was confused all the time.”
FDA Investigates Safety of Essure
The FDA received over 9,900 complaints about Essure side effects from the time it was approved in November 2002 until December 2015. According to the FDA, the most frequently-reported adverse events included:
- Pain/abdominal pain (3353 reports)
- Heavier menses/menstrual irregularities (1408 reports)
- Headache (1383 reports)
- Fatigue (966 reports)
- Weight fluctuations (936 reports)
- Patient device incompatibility (941 reports) (for example, possible nickel allergy)
- Migration of the device or device component (482 reports)
- Device operating differently than expected (301 reports)
- Device breakage (259 reports)
- Malposition of the device (133 reports)
Should the FDA Recall Essure?
Bipartisan lawmakers have called on the FDA to recall Essure. In October 2015, Rep. Mike Fitzpatrick (R-Pa.) introduced legislation to revoke approval for Essure. Rep. Rosa DeLauro (D-Ct.) told the FDA that “Essure’s benefits to not outweigh its risks, and it should be withdrawn from the market.” However, the FDA has refused to recall Essure because it might still help a few women who need to be sterilized without surgery.
Essure Recalled and Banned in Brazil
In February 2017, the Brazilian health regulator Anvisa recalled Essure and banned sales. Bayer has sold around 250,000 Essure implants outside the United States, but Anvisa did not say how many women in Brazil were implanted with Essure. Anvisa issued this warning: “[Essure] is classified as maximum-risk. It can cause changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity, or immune-type reactions.”
How Could Essure Cause Chronic Pain?
General pain and discomfort was reported in 2.9% of women on Essure and hundreds of women have reported chronic pain. According to the FDA, there several ways Essure could cause chronic pain:
- Improperly positioned device in the fallopian tube
- Uterine or fallopian tube perforation
- Migration into the abdomen or pelvic organs
- Tubal pressure
- Nickel allergy with or without local inflammation
Hundreds of Women Report Nickel Allergy and Hypersensitivity
An estimated 10-25% of all women in the United States are allergic to nickel. Essure contains nitinol, a combination of nickel and titanium, and releases tiny amounts of metal that tapers off over time. By September 2015, the FDA has received nearly 900 reports of allergy/hypersensitivity reactions (46% in women with nickel allergies), including 212 reports of women who had Essure removed after allergic reactions.
Need an Essure Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Essure lawyers for a free lawsuit review.