Essure was approved by the FDA in 2002 as a less-invasive form of female sterilization. Essure is a metal coil that is inserted into each fallopian tube and causes fibrosis, or thickening/scarring of connective tissues, in order to block the tubes.
What Is Essure?
However, Essure became controversial in 2013, when thousands of women began experiencing severe side effects, including perforation, pain, heavy bleeding, and unintended pregnancies. Some of these complications led to surgical removal of the Essure device, tubal ligations, and even hysterectomies. By 2017, Essure was recalled in France and Ukraine. Bayer also voluntarily withdrew from selling it in Finland, Canada, the United Kingdom, and the Netherlands. While the company insisted that the halt of sales didn’t have to do with safety, Bayer is facing upwards of 16,000 Essure lawsuits as of 2018.
In the United States, Bayer announced that it would stop all sales of Essure by the end of 2018. According to Reuters, doctors can actually continue to perform procedures using Essure until the end of 2019, at which point they will have to return any devices left over.
If you have used Essure and have experienced any complications or severe side effects from it, contact our experienced team of lawyers today. We’ll help you get the justice you deserve, with no cost to you unless we’re successful. Contact us now!
Complications and Risks of Using Essure
The Essure procedure wasn’t supposed to require general anesthesia, but many women reported pain when the Essure coils were inserted. In addition, because the blockages wouldn’t fully form for three months, another form of contraception would be needed to prevent pregnancy during that time. In those three months, the risks of the chosen contraceptive method would be applicable. In addition, Essure could not protect against sexually transmitted infections, or STIs (also called STDs).
Although the FDA had originally deemed Essure safe, the number of reports of side effects and complications grew after 2013. The FDA revisited Essure and ordered more research and testing. In 2016, the FDA began to require black box warning labels, its most serious type of warning before banning a product. As of 2018, the FDA restricted the sale of Essure and required that patients be warned of all of the risks of using it.
Essure Side Effects
The potential side effects of using Essure include:
- Punctured uterine walls
- Pregnancy, with an increased risk of ectopic pregnancy
- Increased bleeding
- Irregular menstrual cycles
- Back and joint pain
- Hair loss
- Weight gain
- Suicidal thoughts
- Nausea and vomitting
- Brain fog
- Symptoms of autoimmune diseases
- Allergic reaction to Essure
- Heavy metal toxicity
- Itching and rash
- Increased allergic reaction to other allergens
- Perforation, movement or loss of the Essure device
Birth Control Failure
Another common complaint about Essure was that it failed to prevent pregnancy as well as it advertised. Essure was meant to be 99.74% effective as a birth control. However, 1 in 10 women weren’t able to have the device implanted at all, and the risk of pregnancy after having Essure inserted is much higher than with the tubal ligation form of sterilization. In the first year alone, the risk of pregnancy is calculated at 57 per 1000 women.
In addition, if a woman does get pregnant after using Essure, it’s more likely to be an ectopic pregnancy. An ectopic pregnancy occurs outside of the uterus, usually in the fallopian tubes. Ectopic pregnancies pose many concerns. The bleeding can become life-threatening for the mother, and the baby can’t survive.
Removal-Related Risks of Essure
For many of the more severe complications of Essure, the best solution is to remove the device altogether. Although implanting Essure in the first place was non-surgical and could be done without anesthesia, removing Essure requires surgery.
A tubal ligation is often done at the same time, since Essure was supposed to be the easier alternative for a woman considering getting her tubes tied. Unfortunately, some women who experienced extreme complications with Essure were forced to get a full hysterectomy.
Because it is a surgical procedure, removing Essure carries any of the normal risks of surgery. In addition, there are risks specific to the removal of Essure, including doctors not being familiar with how to properly remove the device. There is also a risk of the coil breaking during the removal process and pieces being left behind, which could then migrate to other parts of the body.
Essure Litigation and Complaints
As of 2018, there were more than 16,000 lawsuits against Bayer over Essure. Many of the complaints were about severe side effects, especially chronic pain, migration of the Essure coil, and perforation. There were also complaints about lack of awareness of these side effects, with many women reporting that they hadn’t been informed of the risks. Although the controversy surrounding the Essure device didn’t begin until 2013, there were complaints of injuries and unintended pregnancies as early as 2002 that were filed with the FDA.
Federal Preemption and Litigation Against Bayer
At first, Bayer was protected against lawsuits by federal preemption, which exempted manufacturers from lawsuits on devices that were approved by the FDA. Nonetheless, there were many lawsuits filed against Bayer, which the company tried to have thrown out under federal preemption. However, a judge in California ruled in 2016 that eleven lawsuits, representing fourteen women, could proceed. That ruling provided a precedent for many other cases, including 200 in California alone.
The California lawsuits against Bayer alleged that the company was negligent in testing and monitoring Essure. The suits also claimed that the device had been misrepresented and that doctors hadn’t been fully informed or trained on its proper use. Many lawsuits were for the harm and injury caused by the device. The number increased after 2016, when the FDA’s security warnings were raised to include the black box warning label.
When Should You Consider an Essure Lawsuit?
Have you experienced complications or severe side effects from Essure coils? Were you not fully informed of the risks of using the device before providing your consent? If so, you may be entitled to compensation for your medical bills, suffering, and other damages. Contact Farah and Farah for a free assessment of your case. There will be no charge unless the case is successful in court.
Co-counsel will be associated on these cases.