Essure is a permanent birth control device that uses coils to create an inflammatory response and form a barrier on the uterus. It was designed for women with tubal ligation, so they could not get pregnant again via their fallopian tubes. However, many people who have used Essure later discovered it had caused serious injuries—including perforated uteruses and severe pain during periods of implantation or ovulation. After years of litigation against Bayer HealthCare, more than 50 million women in America were allowed access to free medical care as well as compensation from the company through March 2020.
The “symptoms of essure rejection” is a condition that some women have after using the Essure implant. The FDA has approved a new device, which will be available in June 2018.
Bayer says that Essure is being withdrawn because of “inaccurate and misleading advertising,” however the number of Essure side effects tells a different picture.
Bayer said on 20th of July, 2018, that it will no longer market Essure, a permanent birth control device. The gadget is presently only available in the United States.
Some women report that receiving Essure, a non-surgical alternative to tubal ligation that entails placing a nickel-titanium coil into each fallopian tube, turned their life upside down. They’ve described excruciating agony as the coils snapped, rusted, or moved elsewhere in their bodies, perforating their organs in the process.
While Bayer says that their decision was based on “misleading and false advertising,” the number of adverse events reported to the FDA by women tells a different narrative. More than 25,000 women have reported problems with the device after it was implanted.
Back discomfort, stomach pain, severe cramps, pelvic pain, headaches, menstrual changes, and painful intercourse have all been described as Essure adverse effects by women. Nickel-based coils have caused allergic responses in certain women. What makes these problems so heartbreaking is that removing the device and putting an end to the patient’s misery is frequently only possible via a hysterectomy.
E-Sisters Rejoice at the End of a Protracted Battle
Bayer’s announcement has been anticipated for a long time. For years, women have been screaming about the device’s risks, demanding a ban and holding Bayer responsible for putting their health at risk.
We spoke to Angie Firmalino, the creator of the Essure Problems Facebook page, about what this news means to the more than 36,000 women who have reportedly been damaged by the device.
“This gadget will no longer cause damage to women. We have triumphed, and we have triumphed at long last.”
“It’s taken seven hard years of struggling to have Essure taken off the market in the United States, but it’s finally paid off. The news that Bayer would stop selling and distributing Essure on Friday has brought us all to our knees in thanks, relief, and joy. This gadget will no longer cause damage to women. We have triumphed, and we have triumphed at long last.”
Firmalino and her fellow “E-sisters” have worked hard to raise awareness about Essure, rallying in front of FDA headquarters, meeting with FDA Commissioner Scott Gottlieb, and sharing their stories with the media, including Netflix’s new documentary The Bleeding Edge, which exposes how dangerous devices like Essure get FDA approval.
“The past few weeks leading up to The Bleeding Edge’s Netflix launch have been a frenzy,” Firmalino stated. “I think the Tribeca Film Festival premiere, all of the screenings, the march at Bayer headquarters, Connecticut Medicaid’s decision to stop covering Essure, and our recent communication to FDA Commissioner Gottlieb all had a role in the market withdrawal.”
A Timeline of Essure’s tumultuous History
Essure’s long-awaited exit from the market was neither easy nor swift. The most prominent Essure-related safety warnings and controversies are listed here.
Essure has been approved by the FDA and is now available on the market. It was first offered by Conceptus, which is now a Bayer subsidiary.
Essure now comes with a nickel sensitivity warning from the FDA. Conceptus successfully petitions the FDA to remove the contraindication, and the FDA agrees.
Angie Firmalino founded the Facebook group Essure Problems, which allows women who have been harmed by Essure to share their stories. It presently has a membership of over 36,000 people.
Essure must include a warning for persistent pain and device migration, according to the FDA.
April of this year
According to one research, women who have Essure are more than ten times more likely to become pregnant than those who get standard laparoscopic sterilization.
In September of 2015,
The FDA’s Obstetrics and Gynecology Devices Panel has issued Essure guidelines, cautioning that certain women with nickel allergy, severe pelvic discomfort, autoimmune illnesses, or previous uterus surgery should avoid using the device.
The month of February 2016
Bayer must perform a new post-marketing safety study “intended to give crucial information about the device’s hazards in a real-world scenario,” according to the FDA.
In November of 2016,
The FDA issues tougher black box warnings for Essure, the highest level of warning available, “intended to draw attention to significant or life-threatening hazards.”
September of this year
Bayer has announced that it would no longer market Essure outside of the United States. The announcement follows recalls earlier this year in Brazil and Australia.
In December of 2017,
In 2017, the FDA received 11,854 Essure adverse event reports, more than double the 5,019 reports received in 2016.
February of this year
Five Essure Problems founders, including Angie Firmalino, met with FDA Commissioner Scott Gottlieb to request that Essure be taken off the market temporarily. They provide poll data, photos, and anecdotes from other members to demonstrate the device’s risks.
April of this year
Prior to the device’s deployment, the FDA mandates healthcare practitioners and institutions to give patients with pamphlets and information about potential Essure problems.
20th of July, 2018
Bayer has announced that it would no longer market Essure in the United States by the end of 2018. The decision was made due to dwindling sales and “inaccurate and misleading press,” according to the firm.
27th of July, 2018
“The Bleeding Edge,” a Netflix documentary, opens.
CNN publishes an analysis of federal data showing that Bayer allegedly paid doctors $2.5 million for Essure-related consulting fees and other services between August 2013 and In December of 2017,.
Thousands of women have filed a lawsuit against Bayer.
In the United States, more than 16,000 women have filed claims against Bayer. Essure is faulty and excessively harmful, according to the complaints, and Bayer failed to follow federal safety regulations.
You may be entitled to bring a case if you were implanted with Essure and had serious adverse effects such as stomach discomfort, irregular menstruation, or device migration. A case against Essure may be able to help you get compensation for medical fees, pain and suffering, and other expenses.
To discover whether you have a case, call us for a free, no-obligation legal consultation.
The “how effective is essure after 10 years” is a question that has been asked by many women who were implanted with Essure. The device was originally designed to be permanent, but it was removed from the market in 2016.
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