The U.S. Food and Drug Administration (FDA) is suing Bayer for the controversial, sterilizing implant Essure which left hundreds of women with internal scarring or coils that migrated from their fallopian tubes causing numerous problems including pain during sex and difficulty conceiving natural children. If a judge sides against Bayer, this could have huge implications for other medical devices in addition to addressing a widespread public health concern regarding birth control options .
The “essure lawsuit settlement amounts 2020” is a case where women have filed a lawsuit against the manufacturer of Essure. The plaintiffs in this case are seeking compensation for the damages they have suffered from using the device.
(As of July 20, 2018)
Essure, marketed as the only nonsurgical permanent birth control, is an alternative to having one’s “tubes tied.” For years, Bayer claimed that Essure had a lengthy history of safety and efficacy, but these claims have been called into doubt by women who say that the device has gravely harmed their health, as well as specialists who find flaws in the product’s safety studies.
Bayer said that the gadget will be phased down by the end of 2018.
Two years after the FDA issued a “black box” warning for the device, Bayer said that the gadget will be phased down by the end of 2018. While this will ensure future women are protected from the alleged side effects and complications associated with the device, women who underwent an Essure procedure and experienced health complications should know that they still have rights, including the right to take legal action against Bayer.
Our lawyers are currently consulting with women who have been affected by the device and filing cases on their behalf against Bayer.
Consultation with an attorney is free.
What Is Essure and How Does It Work?
Essure is a nickel and titanium alloy coil insert that is tiny and flexible. One coil is put in each fallopian tube during an Essure treatment. Scar tissue builds around the inserts over the course of three months, forming a barrier that hinders contraception.
Essure, according to Bayer, is 99 percent successful when used correctly.
What are the Side Effects of Essure?
Essure was approved by the FDA in 2002. Women have reported over 25,000 Essure-related adverse events and at least 40 Essure-related fatalities to the US Food and Drug Administration since its approval (FDA). The FDA received 11,854 adverse event reports in 2017. The following were the most often reported issues:
- Pain, particularly pain in the abdomen
- Menstrual irregularities/heavy periods
- Variation in weight
- Incompatibility of devices
- Device failure or migration
- Nickel-induced hypersensitivity
- The device is not performing as planned.
- The gadget is positioned incorrectly.
- Pregnancies that are unintended, such as ectopic pregnancies
- Perforation of the fallopian tube, uterus, and colon
Essure has been linked to at least 40 fatalities, including eight adult deaths, 20 miscarriages, and four cases of newborn death after live delivery, in addition to these adverse effects. According to a more recent review of Essure side effects, the device may have resulted in more than 300 fetal deaths.
Essure’s Regulatory History
Conceptus Inc., which Bayer bought in 2013, received the first FDA clearance for Essure. Around a million of the gadgets have been sold globally, with the majority of them in the United States. The FDA has authorized multiple labeling modifications since the device’s launch, including a new nickel sensitivity warning (2011), a warning concerning chronic pain and device migration (2013), and a “black box” warning (2014). (2016).
Concerned that women weren’t receiving enough information about Essure’s hazards, the FDA mandated in April 2018 that all health care practitioners and institutions deliver a patient pamphlet and address potential Essure issues before implanting the device. Providers that do not comply with this regulation may risk criminal or civil fines.
The FDA Board Discusses the Safety of Essure
In 2015, the FDA called a meeting of its Obstetrics and Gynecology Devices Panel in response to hundreds of complaints from women about Essure. The panel recommended that some women, particularly those with a nickel allergy or hypersensitivity, persistent pelvic discomfort, autoimmune illnesses, or past uterus surgery, avoid using Essure.
Essure’s clearance for marketing was based on non-randomized, non-blinded trials with no control group.
Bayer was also chastised by the panel for neglecting to gather data that may have helped foresee women’s risks. Panelists echoed other experts in pointing up flaws in Essure safety research. Doctors note out in a paper published in the New England Journal of Medicine that Essure’s pre-marketing approval was based on nonrandomized, non-blinded trials with no comparator group. According to the experts, post-approval studies have similar issues.
“Although very low rates [of adverse events] were reported in several of these publications,” an FDA panel member said at the hearing, “major limitations must be taken into account when analyzing the data.”
In the United States, Bayer received 15,000 Essure adverse event complaints, according to a company official. Women who claimed to have been affected by Essure offered emotional evidence about the health difficulties they had as a result of the device. They complained of autoimmune disorders, abscesses and tumors, exhaustion, extreme muscular weakness, bowel control problems, and other concerns.
The FDA authorized Bayer to perform a new Essure post-marketing safety study in February 2016, saying it was “intended to offer crucial information regarding the device’s hazards in a real-world situation.”
Bayer has announced that they would no longer sell Essure by the year 2019.
Bayer said in September 2017 that it will discontinue distributing Essure outside of the United States. Essure victims met with FDA Commissioner Scott Gottlieb to tell their tales and seek an FDA ban, angry that American women may still be damaged by the device.
Bayer said on July 20, 2018, that it will discontinue distributing Essure in the United States by the end of 2018. They cited Essure’s falling sales and “inaccurate and deceptive PR” as reasons for their decision.
Victims of Essure in Their Own Words
The “Real Stories from Women with Essure” part of Bayer’s Essure website contains testimonies from women who have undergone the Essure surgery.
However, these tales do not convey the complete picture. Stories from women for whom Essure did not work as anticipated are conspicuously missing from the website.
Here are some less enthusiastic reviews of the Essure procedure:
- “Every day, I’m in agony.” “Some days are more difficult than others.” Cecilia B. –
- “I had discomfort across my whole body after 12 months of being implanted. Make sure this doesn’t happen to any other ladies.” Kim H. –
- “There were times when I couldn’t get out of bed except to cry my way to the restroom.” I didn’t feel like a lady, and I didn’t feel like a person. Essure’s pre-market clearance should be rescinded because it is the only, only appropriate answer for the women who are suffering, the mothers and children who have perished, and the families who have been ripped apart.” Rebecca H. –
- “I had Essure a few months after the birth of my fourth kid. My periods have become heavier and more irregular, despite the fact that I had always been regular. My hair began to thin, fall out, and become brittle; I always have some random itchy rash on my legs; I have [debilitating] migraines; I have chronic pain, particularly lower back pain, pelvic pain, and pain during intercourse; most mornings I feel like a bus has hit me; I have to sleep on a heating pad nightly, moving it from my pelvis to my back; I have to sleep on a heating pad nightly, moving it from my pelvis to I have difficulty with memory, focus, disorientation, and mood. They diagnosed me with Fibromyalgia and ADHD after the Essure operation; none of these symptoms existed previous to the procedure, and they all appeared quickly and did not go away with any therapies.” Shanna –
- “While I was having a surgery to remove the cerclage, which was one of the most traumatic experiences of my life, the high-risk doctor doing the treatment immediately stopped and said, ‘what the (profanity) is an Essure coil doing in her vaginal tract?’ The coil had never been put in my fallopian tube and had spent the whole pregnancy floating about within my uterus. The coil had pierced the amniotic sac, causing it to burst and resulting in the loss of mine and my husband’s lovely baby girl.” — Unnamed FDA source
What are the allegations in the Essure lawsuits?
Essure cases have already been filed against Bayer, with many more on the way. Lawsuits claim, among other things:
- Essure has a flaw.
- Essure is an unnecessarily risky drug.
- Bayer violated government safety regulations.
- Bayer was aware of Essure’s negative effects but failed to provide adequate warnings.
- Bayer was not thoroughly tested. Essure
- If plaintiffs had been fully advised about the risks of Essure, they would not have used it.
Who Can File a Lawsuit Against Essure?
A woman must have been implanted with the device and had negative side effects such as stomach discomfort, irregular menstruation, bleeding, or device migration to be eligible for an Essure lawsuit.
Is it necessary for me to hire an attorney?
Because federal regulations shield Bayer from some sorts of personal damage claims, Essure is a unique product liability lawsuit. These regulations (sometimes known as “federal preemption laws”) govern how Essure devices are categorised and how Essure was authorized by the FDA.
The fact that certain lawsuits against Bayer have been permitted to advance is encouraging for all women who may have Essure claims. Nonetheless, because of the particular issues in Essure litigation, it is vital to deal with an experienced law firm that can put together a case strong enough to overcome Bayer’s legal defenses.
What to Do If You’re Afraid You’ve Been Affected
Our lawyers can assist you if you or a loved one had the Essure device installed and believe it has had a detrimental effect on your health.
We are one of the country’s biggest and most prestigious personal injury companies, with considerable expertise handling these sorts of situations. To find out whether you are due money for damages, contact us for a free, no-obligation legal consultation. You will not be charged anything until we win your case.
The “essure lawsuit deadline” is the date that a law firm must file their claim to be included in the lawsuit against Essure. The law firm has until this date to file their claim.
Frequently Asked Questions
Can I still file lawsuit against Essure?
A: While there is still a possibility that you could file suit against the manufacturers of Essure, it would be unlikely. The FDA has already done their due diligence and released guidelines for women who are affected by the device to seek out other options outside litigation.
What is the average payout for Essure lawsuit?
A: This is a very hard question to answer because it depends on the type of claim and what evidence has been presented. There are many factors that go into determining an average payout, but generally speaking, with as much information as you have provided me so far I can give you a range for where your case might fall in terms of compensation.
How do I join the Essure lawsuit?
A: The lawsuit is filed in United States District Court for the Northern District of California. You can file an amicus brief using this form under amicus curiae, or you can find out more information through the courts website, which explains how to contact them and provide your input as a third party.
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