Essure is a birth control device manufactured by Bayer that has now been discontinued. The use of Essure caused a variety of severe health problems in women, such as organ perforation, pelvic pain, vaginal bleeding, and painful sex. Citing that Bayer promoted the birth control device without disclosing its severe side effects to the public, thousands of women filed a class action lawsuit against the company.
Eventually, Bayer discontinued the manufacturing and sales of Essure in 2018. And in 2020, Bayer agreed to pay $1.6 billion to settle all the Essure class action lawsuits. We will be covering all necessary information about Essure, its possible side effects, and details about the lawsuit filed by women against this birth control device and its manufacturer Bayer.
Overview of Essure
Essure was manufactured by Conceptus, and it was approved by the FDA in 2002. Later, Conceptus was acquired by Bayer in 2013. Essure was marketed as a birth control device that is 99% effective at preventing pregnancy. However, its side effects and complications were not publicly disclosed.
Gradually, thousands of women who used the device started experiencing a range of health problems, which could be mild and temporary, like headaches or severe long-term conditions such as the onset of auto-immune diseases.
These issues quickly caught the attention of women in the US, leading to the formation of support groups and the filing of class-action lawsuits by more than 30,000 women affected by the device. The devastating effects of Essure were even discussed in the 2018 Netflix documentary, The Bleeding Edge.
How Does Essure Work?
To get a better understanding of Essure’s side effects and the basis of the class action lawsuit filed against it, it helps first to know how the device works. Essure is a metallic tube-like, non-surgical birth control device inserted into a woman’s fallopian tube through their vagina by a doctor using a catheter tube. Once the device is placed in the fallopian tubes, it leads to scar tissue formation in the tubes, which blocks the sperm from traveling to the ovaries, thus preventing pregnancy.
After three months of implanting Essure, a confirmation test is done to check if the scar tissues have fully developed, either with a transvaginal ultrasound or a vaginal x-ray. When the test confirms that the device has successfully caused scar tissue formation, it needs to be removed. Even though implantation of Essure is non-surgical, its removal had to be done by a minor surgical procedure.
Side Effects of Essure
As the complications of Essure came to light, people became aware of its side effects. The FDA received reports from many users, and in 2016, they issued a notice to Bayer to have a black box warning displayed on Essure to notify people about its side effects. So let’s take a look at all the possible side effects of Essure, ranging from mild to severe.
Short Term/Temporary Effects
The short term effects of Essure include back and pelvic pain, nausea, cramps, headaches, and vaginal bleeding. These symptoms may appear shortly after implantation and subside after some time.
Long term Effects
More serious long term effects of Essure include:
- Hair loss
- Migration of device from fallopian tubes to abdominal region, causing organ perforation.
- Autoimmune disorders
- Unwanted pregnancy due to failure of the device
- Ectopic pregnancy, a more dangerous form of pregnancy that happens outside the uterus
- Allergy from metal
- Chronic pain as well as pain during intercourse
Some women have also claimed that the device but just migrated to their abdominal region and broke into pieces, causing dangerous internal damage to the body. A few cases of deaths owing to Essure has also been reported.
Essure Class Action Lawsuit– What You Need to Know
The side effects of Essure has caused serious complications in women, which has also affected their social lives and marriage. As such, thousands of women sued Bayer for marketing the device as highly effective and safe while not conducting studies on its side effects in advance and not making the public aware of the possible complications.
Many women who filed these class action lawsuits also contacted FDA and asked them to restrict Bayer from selling Essure in the market. However, in 2018, Bayer themselves discontinued sales of the device, but they stated the reason for it as the decline in sales, trying to shift the focus to financial reasons instead of health concerns.
The class action lawsuit against Essure has also been quite challenging, as Bayer defended themselves, stating that they had received approval from the FDA, which gave them the green signal to sell the device from a legal point of view. But their defense was countered with three main points:
- Bayer did not train physicians on the proper implantation process of the device. They were only trained with a virtual simulation, and no hands-on training was provided.
- Bayer did not notify the public about the severe side effects of Essure. They concealed reports of serious issues caused by Essure and proceeded to market and sell the device even as its effects were slowly being highlighted.
- Bayer marketed the device as safe and highly effective when in reality, it was capable of causing severe complications in women.
While the sale of Essure is now discontinued, the existing supplies that entered the market before its discontinuation in 2018 have not been recalled. It becomes essential to highlight the effects of Essure to as many women as possible. And if you have used this device and suffered complications due to it, you too can join in the class-action lawsuit against Bayer by contacting us. Speak to us to learn more about Essure class action lawsuit and how you can benefit from it.