04 Apr ESSURE PROBLEMS | ESSURE SIDE EFFECTS | ESSURE LAWYERS
Essure Problems | The Essure method of permanent sterilization was first approved in 2002 and apparently offered many more advantages than tubal ligation. 15 years later, things have not gone as planned
When Carolina Hernandez decided that she did not want to have more children , she decided to look for a contraceptive method that was absolutely effective and had only one condition: not invasive.
A quick Internet search was enough to find what appeared to be the perfect solution. It was a small device, which was inserted into the fallopian tubes, marketed by the all-powerful Bayer. An invention that seemed revolutionary. “In the hospital they told me that it was wonderful, that I did not have a single side effect, that it was 100% titanium, I would do it in consultation and that the next day could lead a normal life.”
It was 2005 and everything went as promised. But, only 5 years later, the first and atrocious secondary symptoms began to appear. Painful rules, urinary infections, blood in stool and urine, constant fatigue and above all, much pain. Head, lumbar, knees, elbows, back, abdomen, bones … a generalized pain that prevented him from performing even the simplest tasks.
Today Carolina is part of the 80,000 women who have implemented Essure since its launch in Spain in 2003 and is one of the 1,000 affected (according to the Spanish Association of Affected by Essure) for the contraceptive method that was once considered As “the safest in the world”.
She is not the only one to suffer in her flesh. Just one week ago, another of the affected, Carolina Díez , filed the first complaint in Spain for the side effects of this contraceptive. In the complaint, he blamed the Ministry of Health, the National Health System and the Spanish Agency for Medicines and Medical Products (AEMPS) “for failing to supervise and control the health of the product, as well as for evaluating notifications of incidents received And elaboration of informative and sanitary alerts “.
Her decision is a pioneer in Spain, but it follows the recent ban on implantation in Brazil and the struggle that has long been carried out by women around the world for the prohibition of this device. Because the reality they have of the safest contraceptive in the world has nothing to do with what they were told.
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Essure is the trade name that hides behind small nickel-plated springs, not titanium as they promised Carolina, which are implanted in the tubes through the uterus. ” This device causes local inflammation that obstructs the tubes and prevents fertilization,” said Dr. Juan Gervás and Mercedes Pérez-Fernández, authors of the book The Medical Bane with Women (Libros del Lince).
The advantages? Apparently many more than her older sister, the tubal ligation. “It can be applied without anesthesia in a consultation, they do not need hospital admission nor surgical intervention,” explained Gervás and Pérez-Fernández.
It was brought to Spain in 2001 and promoted as a “permanent and definitive method, almost 100% effective”. “We are dazzled by the novelty,” says Enriqueta Barranco, a doctor who specializes in gynecology and obstetrics. Now, 16 years after her presentation, Dr. Barranco considers that from a medical and professional point of view and from the perspective of women’s health surveillance, “its introduction into the market was precipitated” by all The complications that the device entails.
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Lourdes Peñarolla was placed the Essure in 2006, with 36 years. In 2007 they began their visits to the hospital suffering from pelvic pain. “At first I had pains in the English and in the kidneys, as if I had lumbago,” he tells us. As time passed, the situation was worse and Lourdes began a pilgrimage by various specialists who failed to give an answer to their pain.
“Whatever I (got) did not work. My flesh ached. I had pains, contractions, my pelvis hurt and I could not even walk. I was extremely fatigued, I was anxious to see how I, a young woman of 40 years, could not do anything. It was hard for me to get out of bed, to get dressed, to accompany my daughter, to hit my day in the bathroom with diarrhea. These last 2 years have been awful, “he maintains.
A story like that told by Gloria Quero, a 44-year-old woman who still has this method of contraception. “I have it since February 2006, but I’m trying to get it removed,” he said. “At first it was neck pain that I related to my work in the field. Over time, there were digestive problems, bad digestions, vomiting, muscle aches, anxiety and stress problems, dry eyes, vaginal infections and urine every month, “he reports. “I was wrong but I never had any connection with the Essure. There are so many different things that you wonder what the hell may have to see a contraceptive method with everything that happens to you, “explains Gloria.
“As with all medical devices and devices, Essure was approved with fewer requirements than usual for medicines, ” says Gervas . This is corroborated by Dr. Julio Novoa , an American obstetrician who works at Meharry Medical College, El Paso (Texas) and one of the largest anti-Essure activists in the United States.
“Essure ‘s clinical and pivotal studies were the weakest types of study that could have been done.” The key clinical trials used to gain prior market approval were based on two non-random, non-blind studies, without a control group, in which a total of 926 women were enrolled. While they were prospective studies, a considerable number of patients were withdrawn from the study or lost at follow-up, which affected the assessment of safety and efficacy. Much of the data was also based on telephone surveys rather than a physical examination of the patient in a standardized environment by a physician, denounces Novoa.
Bayer, the company in charge of its commercialization, defends itself by arguing that ” scientific studies have been conducted with Essure – including clinical and post-authorization studies – involving more than 14,000 women ” and ” Years (post-authorization) of Essure do not reveal any new security problem or a higher incidence of known problems. ”
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But to all the health effects of women surrounding the method also must add those that leads to malpractice at the time of placing the device. Among them, the migrations of the Essure out of the fallopian tubes or tubal perforation.
“When they did the necessary tests, they discovered that I had my Essures migrated to the uterus. Of 12 rings the device had 10 of one and 8 of another migrated to the uterus. And despite that the doctors told me that it was not proven that it is the Essure that caused me all this pain, Lourdes laments.
In Carolina’s case, her devices traveled a little further. ” When I had an X-ray they realized that I was wearing 3 implants and not 2. Nobody had warned me about it, although according to the prospect, nothing happens because they put more than 2 devices,” Carolina explains. However, in his case one of the docks traveled to the intestine and ended up staying there. “Every time I sneezed, I would nail it. From there came the blood in the feces and urine, ” says the affected.
There have also been cases of women who experienced perforation of the fallopian tubes.
“One of the aspects of the Essure that bothered me the most, but I never gave it importance until problems began to occur, was that the method acts causing an inflammation that leads to a destruction of the tissue of the tube,” explains Henrietta Barranco. “And in that process many times the tube tissue is pierced by the device. Not only when inserting it if you do not have the appropriate expertise but also in the process of destruction of intratubular tissue, “says Barranco.
” It is an aggressive method by its own way of behaving inside the trunk but also by its own mechanism of insertion. And when put by a person who is not trained, it is not so easy, “summarizes Barranco.
All this causes Essure to present up to 10 times more risk of reoperation due to problems with device placement than tubal ligation, as noted in a study published by the British Medical Journal in 2015.
And on most occasions, operations are the only solution to end the suffering of patients. “I left the operation and all the pain was removed,” explains Lourdes. “My daughter tells me ‘Mom, you look like another person,’ ” says the patient. “I put it on when my daughter was 4 and she did not know me well.”
“In September of last year I got them to operate, I left the operating room and my stomach did not hurt again, or my hips, I even got fat because I can eat everything ,” explains Carolina. “I have recovered my life because, in the end, the pain conditions the way you live,” he maintains.
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From the first moment of its commercialization, the pharmaceutical company has been busy in using its supposed effectiveness as advertising hook. If you take a look at the website of the device, the first thing you discover is a banner that states one of the main advantages of Essure. “Essure is more than 99% effective at preventing pregnancies.” A statement with which the most critical to the device are very little agreement.
“Although presented as an almost 100% effective method, there are doubts about its effectiveness,” explain doctors Juan Gervás and Mercedes Pérez-Fernández. Those doubts were reflected in a scientific study published in Contraception Journal comparing the pregnancy rate in patients with Essure and with tubal ligation. And the result revealed that the number of pregnancies was up to 10 times higher in the case of the docks.
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But then, why is it still implanted a contraceptive that causes constant damage and does not even give what it promises? Why does no one warn in consultation about their true nature?
“In the last 5 years, there has been a fundamental change in public opinion as well as in doctors’ practices regarding the number of Essure devices that are placed in the United States and around the world,” explains Julio Novoa . An awakening that has resulted in several key actions.
The first: the labeling “Black Box” by the US FDA. “In 2016, the FDA imposed a serious injury warning and made a list of possible damages that women must complete before giving their consent,” Dr. Gervás and Dr. Pérez-Fernández explain.
Following pressure from US organizations and civil society, the FDA was forced to force Bayer to conduct a long-term clinical trial of the device’s safety, efficacy, and autoimmune reactions by early 2016. To this must be added that the claims against Bayer following the intervention of activist Erin Brockovich have not stopped rising. “A review of annual financial reports has shown that Bayer has so far spent at least $ 415 million on the legal defense of the Essure device,” summarizes Dr. Novoa.
Outside the United States, Essure has been banned in Brazil by ANVISA, the drug regulatory body equivalent to the FDA, due to the significant number of complications and device failures. “And in Holland, one of the countries that most actively promoted the use of Essure in its beginnings, has become one of the zones of the world where fewer devices are currently placed, ” explains Julio Novoa.
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Since March 2016 physicians must inform patients in Spain about the possible adverse effects of Essure and the withdrawal protocol of the device body. “In addition, recently SEGO has completed the information related to Essure for both users and medical professionals,” said Bayer.
However, those affected report that it is not enough. “The last girl on the Free Platform of Essure put it on January 17 and they repeated to me when I put it in 2005. It was composed of titanium, it had no side effects and they did not report it at all. Nothing, “says Carolina.
With all this, more and more voices advocate for the prohibition of this method, as has happened in the Brazilian case. As Dr. Gervás and Pérez-Fernández summarized: ” Essure devices should not be approved, should never be used and should be withdrawn from the market as soon as possible.” Along this line is a campaign of Change.org initiated long ago by the Spanish Association of Affected by Essure, which calls for a total ban on the method in Spain.
And while that happens, those affected just want this to end. Lourdes and Carolina have already been operated on and Gloria is waiting for her operation; “I’m looking forward to seeing myself, as other comrades tell me. Their stories give me the encouragement and hope that everything will work out in the end.”
Contact Peiffer Wolf Carr & Kane today. We are YOUR Essure Lawyers for Essure Problems
While fighting Bayer in the courts on behalf of 1000’s of women, we have continued to uncover more and more alarming data about Essure, Essure Problems, and how Essure Problems are being reported by Bayer to the FDA. If you or someone you know has been injured or experiencing side effects from the ESSURE Birth Control Implant, contact Peiffer Wolf Carr & Kane TODAY or Call 504-523-2434.