Essure Lawsuit Settlement - Guardian Legal Network

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Essure Lawsuit

For years, many women have used Essure to prevent unwanted pregnancies. However, severe side effects have been associated with the device, such as dangerous ectopic pregnancies, perforation of the fallopian tubes and uterus, unplanned pregnancies, severe allergic reactions, device migration, and death.

If you suffered severe injuries due to a defective Essure birth control device, you will need an experienced defective medical device lawyer on your side. Your lawyer will help guide you through the complex legal process.

The Guardian Legal Network helps people like you who have been wronged by negligent medical device manufacturers and want to take legal action. We can connect you with a qualified lawyer who will help you seek justice.

What is Essure?

Essure is a permanent birth control device designed to prevent pregnancy without the need for surgery. Essure is the only type of birth control device on the market designed to permanently prevent pregnancy without surgery. This makes it an attractive option for many women because they can get back to their normal daily activities almost immediately.

Essure was approved by the U.S. Food and Drug Administration (FDA) in 2002 as a Class III medical device. It consists of two small coils designed and manufactured to be implanted into a female’s fallopian tubes to induce fibrosis, scar tissue, and blockage. The results are intended to make the woman infertile through sterilization. Essure was created to be an alternative to surgical tubal ligation.

How Does the Essure Birth Control Device Work?

Essure consists of two metal coils placed inside the fallopian tubes. The Essure coil is designed to cause scar tissue, which will close the tubes and prevent pregnancy. The Essure procedure is conducted in a doctor’s office and usually takes less than an hour. During the procedure, doctors use a small tube to insert the coils into the fallopian tubes through the vagina and cervix.

After the procedure, women still need to use another form of birth control because it can take months for the scar tissue to form and close the fallopian tubes completely. Typically, about three months after the initial procedure, women must go back to their doctor to take the Essure confirmation test. During this test, doctors use dye to see whether or not the tubes are completely closed. If they are not, women may be at risk for pregnancy because sperm can still enter the tubes and fertilize an egg.

Bayer markets Essure as a safe alternative to tubal ligation, which is the only other option women have for permanent birth control and requires surgery. Bayer claims its Essure implant is over 99 percent effective, but women who use it have argued otherwise. There have been reports of unintended pregnancies in women using Essure, along with thousands of other complaints against the device. Women have reported adverse events, including abdominal pain, severe cramping, allergic reactions, and more severe side effects. Now, women are choosing to file lawsuits against Bayer to hold the company accountable for their injuries.

Essure Side Effects

The Essure birth control device is being blamed for serious health problems. Many women who have relied on the device for contraceptive purposes have ended up with the following side effects:

Ongoing pain in the pelvic area
Bleeding and irregular periods
Dizziness
Nausea
Vomiting, bloating
Itchy skin
Feelings of discomfort.

In addition, more severe complications have been associated with the Essure device. These include:

Migration of the device
Perforation of organs including fallopian tubes and uterus
Broken devices
Serious allergic reactions
Expulsion of the implant
Unplanned pregnancy
Autoimmune disorders
Dangerous ectopic pregnancy
Death

Can Essure Be Removed?

The Essure device was not designed to be removed, but due to many women experiencing severe injuries and pain, gynecological surgeons have developed removal procedures. There are two main options available for women looking to remove their Essure device:

Hysteroscopic removal
Laparoscopic removal

Hysteroscopic removal is only possible within the first three months after Essure is implanted. This procedure is done without any incisions. To remove the Essure coils, surgeons will use a camera to look at the coils within the uterus and then simply pull out the device through the cervix. It is ideal for patients to attempt this removal procedure first.

A laparoscopic removal is done if the patient has had Essure for over three months. During this procedure, surgeons will make small incisions to the wall of the uterus to remove the Essure device. Patients are usually sent home the same day with a full recovery time of approximately two weeks.

Surgeons performing this procedure may have different techniques for removal. It is highly recommended for patients looking to remove their Essure device to speak with an experienced and certified gynecologist.

Timeline of Essure Birth Control Device

November 2002 – The FDA approved Essure as a Class III medical device and markets the device as a promising and safe option for female birth control.
2011 – Angie Firmalino, now an advocate for women’s health, has her Essure implant removed after it caused severe injuries and constant bleeding. Firmalino began an “Essure Problems” Facebook group and has been featured in the Netflix documentary, The Bleeding Edge, which showcases the fight against Essure.
September 2015 – FDA advisory committee examined Essure’s post-market data and peer-reviewed research. The FDA also receives reports of women claiming they suffered injuries from Essure.
October 2015 – Research from The BMJ found that women with the Essure implant are 10x more at risk of repeat procedures than women with tubal ligation.
February 2016 – The FDA ordered Bayer to perform a new clinical trial to gather more data on Essure’s health risks. The FDA made this order after receiving thousands of adverse event reports.
November 2016 – The FDA ruled that a black box warning must be included on Essure device labels specifying the risk of abdominal pain, perforation, allergic reactions, and other possible complications.
April 2018 – The FDA restricted Essure sales after receiving around 26,700 complaints about the device. These complaints were submitted to the FDA between 2002 and 2017.
December 2019 – Bayer received all unused Essure devices to avoid further implantations.
April 2020 – The FDA announced they would make reports on Essure publicly available on the Problems Reported with Essure webpage. Also, Bayer notified the FDA that it became aware of Essure’s dangerous side effects from social media information related to litigation.
August 2020 – Bayer agrees to pay an Essure settlement of $1.6 billion to resolve thousands of Essure injury claims in the United States.
December 2020 – Bayer provided the first quarterly analysis report of the negative effects of Essure. The information in this report included data from June 2020 through August 2020.
January 2021 – The FDA posted a spreadsheet containing reports of Essure adverse events that Bayer is required to submit. This is the sixth spreadsheet that has been posted.

Bayer Stops Selling Essure & Agrees to Settlement

In July 2018, Bayer announced it would stop selling Essure Birth Control Implants. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” Bayer said in a statement. It was not until August 21, 2020, that Bayer finally agreed to settle Essure lawsuits filed by injured women. Bayer agreed to pay $1.6 billion to resolve around 90 percent of the 39,000 Essure lawsuits filed against the company.

A 2019 annual report from Bayer noted that there were approximately 33,100 Essure lawsuits filed in the United States. By August 21, 2020, the number of lawsuits increased to around 39,000 lawsuits. Bayer’s Essure settlement agreement will help provide relief to thousands of women who were wrongfully injured by the defective device.

Increasing Number of Essure Lawsuits Against Bayer

Advances in medical technology have provided women with a number of birth control options. Women can choose the type of birth control that is right for them. Medical device manufacturers like Bayer are supposed to provide all the facts women need to make informed decisions about their ideal birth control. However, the massive number of Essure lawsuits shows that women are not getting all the information they need to choose what is right for them.

Bayer is facing an increasing number of lawsuits involving its permanent birth control Essure. Women who were harmed by the device first began filing lawsuits in late 2015 and early 2016. The number of lawsuits continues to rise as more and more women come forward. Since 2016, significant progress has been made in state courts and has allowed those lawsuits to proceed. Bayer’s agreement to settle thousands of these lawsuits in August 2020 is a testament to the perseverance of injured women and legal teams who were committed to seeking justice.

Filing an Essure Lawsuit

Women looking to file an Essure lawsuit are claiming the following:

Essure has forced a patient to undergo additional and/or revision surgery beyond the implantation
Essure was improperly placed during the procedure
Essure caused perforation of the fallopian tubes or nearby organs
Essure has moved or migrated after implant surgery
Bayer did not give adequate warnings to patients and doctors of the dangerous Essure side-effects
Essure was defectively designed and led to severe complications
Essure has caused allergic and immune reactions and recurring pain

Find an Essure Lawyer

If you or a family member had an Essure device implanted and then experienced a severe injury, you may be eligible to seek compensation from the manufacturer. A qualified Essure lawyer can answer your questions and discuss your potential for holding the responsible parties accountable for the damages and injuries you have suffered.

Contact The Guardian Legal Network to find an Essure lawyer who can help you file a claim to get the justice and compensation you deserve.

Guardian Legal Network is not currently processing claims for this lawsuit.

References

Bayer. “Bayer Announces Resolution of U.S. Essure™ Claims”, Bayer, https://bayer2019tf.q4web.com/news/news-details/2020/Bayer-Announces-Resolution-of-U.S.-Essure-Claims/default.aspx. Accessed January 26, 2021.
CBS News. “Thousands of women say Essure birth control caused intense pain”, CBS News, https://www.cbsnews.com/news/essure-birth-control-fda-women-report-pain-side-effects. Accessed January 26, 2021.
FDA. “Essure Benefits and Risks”, U.S. Food and Drug Administration, https://www.fda.gov/medical-devices/essure-permanent-birth-control/essure-benefits-and-risks. Accessed January 26, 2021.
FDA. “FDA Activities Related to Essure”, U.S. Food and Drug Administration, https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure. Accessed January 26, 2021.
FDA. “Problems Reported with Essure”, U.S. Food and Drug Administration, https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure#reports. Accessed January 26, 2021.
Jacqueline Howard. “Essure birth control device tied to higher rates of pain and bleeding, FDA says”, CNN, https://www.cnn.com/2020/07/08/health/essure-side-effects-preliminary-study-fda-bn-wellness/index.html. Accessed January 26, 2021.

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