Essure, also known as the “tamper-proof” birth control implant, was touted for its safety and ease of use. However, many women have found that it can cause serious side effects including chronic pain and perforation in the uterus. A number of lawsuits are now targeting Bayer HealthCare over Essure’s dangerous side effects.
The “essure lawsuit settlement amounts 2020” is a legal case that took place in the US. The case was about women who filed lawsuits against the manufacturer of Essure Birth Control.
(As of July 20, 2018)
Thousands of injuries and hundreds of fatalities have been connected to Essure, a Bayer permanent birth control implant.
More than 25,000 Essure-related adverse events have been reported by women since 2002.
Women have reported more than 25,000 Essure-related adverse events and at least 40 Essure-related fatalities to the US Food and Drug Administration since its approval in 2002. (FDA). The FDA received 11,854 complaints in 2017. Thousands of lawsuits have been filed as a result of these serious adverse effects.
Experts have voiced reservations about the research methodologies used to determine the safety of Essure. They claim that both pre- and post-market research fall short of the highest scientific standards. As a consequence, Essure usage in the real world might be considerably riskier than the tests suggest.
The FDA ordered that a “black box” warning be added to Essure in 2016, but many women felt that this was too little, too late. Women have been calling for Essure to be taken off the market for years. Bayer ultimately confirmed in July 2018 that Essure will be phased off by 2019.
Many women are bringing lawsuits against the gadget, claiming that it has caused them significant and irreparable injury.
What exactly is Essure?
When it originally came out, Essure was hailed as a game-changer since it was the first non-surgical option to tubal ligation (tying one’s tubes). Essure was created by Conceptus, Inc., which got FDA clearance in 2002. When Bayer purchased Conceptus in 2013, it acquired the rights to Essure.
Essure is an irreversible operation.
Essure consists of two small metal coils placed into the fallopian tubes through the cervix and vaginal canal. The operation usually takes less than an hour, and most patients are able to resume normal activities within a few days.
Over the course of three months, the coils cause scar tissue to develop, which acts as a barrier to sperm accessing the eggs. While the scar tissue grows, women must utilize an other method of birth control. Essure should function indefinitely after a confirmatory test to check that the fallopian tubes are not clogged. (This is an irreversible surgery.)
Essure is more than 99 percent successful in preventing Pregnancy, according to Bayer, and is safe for the great majority of women. However, a large number of patient complaints and official study have put these assertions into doubt.
What are the Consequences of Essure?
Through its adverse event reporting database, the FDA keeps track of medication and medical device concerns. Adverse occurrences must be reported to the FDA by manufacturers, but patients may also report issues directly to the FDA.
The FDA received about 26,773 adverse event reports concerning Essure between November 2002 and December 31, 2017. The following issues were mentioned:
- Discomfort in the abdomen/abdominal pain
- Menstrual irregularities/heavy menstruation
- Variation in weight
- Incompatibility between the patient and the device (such as metal allergy)
- Pregnancy complications
- Migration of a device or a component of a device
- Device misalignment
- The device is not performing as planned.
- Breakage of the device
- Inserting or removing the device is challenging.
Furthermore, the FDA has received at least 40 reports of Essure-related mortality, including eight adult deaths, 20 pregnancy loss reports, and four baby deaths after live delivery.
Among addition, the FDA has received at least 1,826 reports of pregnancy in Essure users. Almost half of them ended in a miscarriage.
In September 2015, the FDA conducted an advisory committee meeting in response to Essure safety concerns. During the meeting, Bayer officials addressed questions from panel members and shared scientific facts on Essure. Experts provided their perspectives on the device, women spoke about their experiences with it, and Bayer representatives answered questions from panel members.
Dr. Andrea Machlitt, a Bayer Director of Risk Management, told the panel that the business has received 17,000 adverse event reports, with 15,000 of them coming from consumers in the United States. Essure complaints had surged by 1,400 percent in the preceding three years, according to the FDA.
The true number of Essure fetal fatalities, according to a former FDA staffer who now works as an analyst with the consulting company Device Events, surpasses 300.
Essure Test Data Accuracy Is In Doubt
Experts started evaluating the research used to approve the device, as well as studies completed after approval, as complaints of Essure difficulties grew, and discovered several major faults.
Essure pre-approval studies employed data from 745 women who were monitored for five years after the device was implanted. None of the women got pregnant in either research, with adverse events occurring in 2.6 percent of women in one and 9 percent of women in the other. The following were some of the adverse effects that were observed:
- The fallopian tube was punctured with a coil.
- A coil was ejected or stuck in another part of the body.
- Intercourse that is excruciating
- Menstrual periods that are excruciating
- A misplaced coil is removed during surgery.
Despite these negative effects, the FDA authorized Essure since no pregnancies were found in the two tests. However, one condition of approval was that post-marketing research be carried out (FDA often orders post-approval studies).
The limitations of these studies’ data were examined and addressed in a research published in the New England Journal of Medicine, which found:
- Even though Essure is designed to span a woman’s lifetime, few of the women in the premarket approval trials were tracked for more than a year. Only 632 of the 745 women were contacted after a year to see how beneficial the treatment was, and only 197 of the 745 women were contacted after two years.
- The findings of the post-approval studies (which were supposed to give five-year follow-up data on patients in the pre-marketing approval trials) were not released on time. One post-approval research remained unpublished as of October 2015, while the other has just recently been published. Furthermore, only 71 percent of patients in the published research had a five-year follow-up.
- Both pre-approval and post-approval trials omitted critical data, resulting in skewed findings that made determining the real safety and effectiveness of Essure challenging.
- Women receiving the alternative tubal ligation surgery were not included in pre- and post-marketing trials as a comparison group.
“Given the limitations of the relevant research, it’s not surprising that so many years passed before safety risks with Essure were detected,” the NEJM study author wrote. According to the facts, [Essure] is neither as effective nor as safe as the premarketing approval review suggested.”
The results of one of the long-awaited follow-up studies were eventually published in the Journal of Minimally Invasive Gynecology in April 2015. The following were some of the study’s adverse events (based on a five-year follow-up):
- Hysterectomies are a kind of hysterectomy that removes (4 percent of women)
- Periods of heaviness (38 percent )
- Pelvic discomfort that comes and goes (5 percent )
- Periods of excruciating agony (6.7 percent )
- Intercourse that is excruciating (4%)
However, since this research lacked a comparison group, as did the pre-marketing trials, it’s impossible to evaluate if these risks are excessive.
Third-party research, which was not supported by Bayer and was not vulnerable to the flaws observed in previous studies, yielded very different findings. In a 2014 study comparing Essure to laparoscopic sterilization, researchers discovered that the chance of conception with Essure was more than ten times higher over a 10-year period than with the conventional sterilization approach.
A study published in the British Medical Journal the following year indicated that 2.4 percent of Essure patients needed follow-up surgery a year after getting an implant, compared to just 0.2 percent of women who had standard sterilization surgery. Extrapolating the findings to all Essure users in the United States, the research estimates that 150,000 Americans have had or will undergo further surgery.
The FDA has issued a black box warning for Essure.
In February 2016, the FDA issued a new boxed warning, the FDA’s strictest warning, in an attempt to “alert patients of possible dangers” from Essure. In November 2016, fresh warnings were issued.
The FDA also ordered Bayer to undertake a new Essure post-marketing study and offered a “patient choice checklist” to assist patients in better understanding Essure’s dangers. Since April 2018, health care practitioners and institutions have been obligated by law to provide patients a pamphlet outlining the hazards of Essure implantation. Those who fail to comply may be subject to civil and criminal consequences.
Victims of Essure have access to a variety of resources.
Victims of Essure side effects may find solace in the company of others who have gone through the same thing. One frustrated Essure user, for example, created the Essure Problems website and Facebook page to warn other women about the device and share her own story. More than 34,000 people have joined the Facebook group.
In addition, well-known consumer advocate Erin Brockovich founded the website Essure Procedure to allow women to share their tales and concerns about Essure, as well as to push for the device’s outlawing.
Have you been harmed by Essure?
Thousands of Essure cases have been filed throughout the country claiming that Bayer (together with Essure’s original creator, Conceptus) was aware of the device’s hazards and purposefully concealed information about them in order to continue promoting Essure. Failure to warn, negligent misrepresentation, and negligent manufacturing are among the plaintiff’s specific complaints.
Our lawyers are considering legal action against Bayer based on widely publicized Essure adverse effects.
Our lawyers are considering legal action against Bayer based on widely publicized Essure adverse effects.
Whether you or a loved one has suffered major health problems as a result of Essure, call us for a free legal consultation to see if you are qualified for compensation. It costs nothing to talk to us, and you don’t have to pay anything until we win your case.
Essure is a birth control device that has been used by many women. Recently, there have been lawsuits filed against the manufacturer of the device. The “essure lawsuit lawyers” are professionals who work in this field and can help you if you are one of these women.
Frequently Asked Questions
Can I still file lawsuit against Essure?
A: You cannot file a lawsuit against Essure for the claims made about their product. It is not within your rights to sue these companies because they are protected under federal law from such lawsuits and cant be charged with fraud or deception.
What is the average payout for Essure lawsuit?
A: The average payout for Essure lawsuit is $2,000.
How do I join the Essure lawsuit?
A: You can find out more information about this lawsuit at the link below.https://www.davidkatzmd.com/abortions-questions
- essure lawsuit settlement amounts per person
- essure lawsuit update 2021
- essure lawsuit update 2020
- essure class action lawsuit
- essure lawyers near me