The suffering of women with the Essure contraceptive – 09/28/2023 – Balance and Health

After having her fourth child in 2012, Brazilian Kelli Patrícia da Luz, 43, had been waiting for more than two years for a tubal ligation in the public health system when she received a call from one of the public hospitals in her city, Brasília.

The alternative offered to Kelli seemed even better than expected.

“They invited me to a lecture and introduced Essure to me. They described the device as a revolutionary method, with no cuts, no pain, no need to take time off from work or daily activities. I quickly accepted that it was the best option,” says Kelli .

There was just one limitation: if she regretted using the device, she was informed that the procedure would be irreversible.

Removing the device would require a complete hysterectomy (removal of the uterus and cervix). She signed a liability waiver.

The Essure insertion procedure was done hysteroscopy, using a thin pen-like device. The doctor inserted the device through the cervix to look at the uterine cavity and the internal openings of the fallopian tubes, where the Essure fitted like a spring.

In Brazil, the alternative was available between 2009 and 2017, when it was temporarily suspended. Two years later, in 2019, Anvisa officially banned Essure, classifying the contraceptive as having “maximum risk” due to the possibility of serious side effects.

“The first challenge was related to the hysteroscopy technique, as the professional needs to position the spiral in the tube openings with extreme caution to avoid perforations”, explains Carlos Politano, member of the Contraception Committee of Febrasgo (Brazilian Federation of Gynecology and Obstetrics).

According to the manufacturer, after the procedure, over the course of approximately three months, the body would develop an organic local healing reaction, definitively occluding the canal and preventing sperm and egg from meeting.

Although Essure was not incorporated as a technology available in the Unified Health System (SUS), the device became available in public hospitals in Brazilian capitals, such as Rio de Janeiro, São Paulo and Brasília, which are associated with the SUS, as a option to minimize the long waiting list of women waiting for a free tubal ligation.

“The dissemination and clinical evaluation of Essure took place mainly in public hospitals. The cost was high to offer it in private clinics, so there must have been some agreement — for a lower cost or offer for dissemination — in the public system”, says Politano.

At the Hospital Materno Infantil de Brasília (HMIB), linked to the SUS, Kelli had Essure implanted with excitement and without doubts. After all, the device, created in 2001 with the promise of being a better alternative to tubal ligation, had already been used for more than a decade in different countries at the time.

Essure was approved by the FDA (Food and Drug Administration), the American health regulatory agency, for use in the USA, in 2002, and soon excited the medical profession around the world, gaining followers from several countries — in addition to Brazil, Canada, Australia and several European nations.

The pharmaceutical company Bayer purchased Essure in 2013, and in 2015, revealed to the New York Times that the method was used in at least 23 countries and more than 750,000 devices had already been implanted.

The permanent effects of Essure

But it was also over the years that notifications about problems caused by the method began to accumulate. Between November 4, 2002, the date of Essure’s approval, through December 31, 2022, the FDA received 69,249 reports describing problems related to Essure.

The challenges mentioned included severe pain, bleeding, perforations, difficulties with insertion or removal, among others. Among the causes for the uncomfortable symptoms, different published materials, such as the information from the Queensland government in Australia, mention inflammation caused by the device, allergic reaction to the materials and migration of Essure to another location (this is rarer).

Kelli began experiencing pain shortly after implementation. “This is the most common side effect, not only with Essure, but also with other devices, such as the IUD. It happens because the material is placed in a place where, naturally, it was not designed to receive it”, explains Politano .

But cramps weren’t the only problem she reported facing.

“After the procedure, I had intestinal problems, pelvic pain, bleeding, joint pain and severe migraines. In addition, I suffered from terrible back pain that prevented me from walking,” Kelli says.

It was only in 2017 that serious reports of several side effects suffered by women in several countries — many similar to Kelli’s, and others beyond — became public. It was the beginning of the discontinuation of the use of Essure around the world.

In the same year, countries such as Brazil, Canada, and members of the European Union preventively suspended the use of the method.

In the US, the FDA now includes a “black box” warning, which means the drug can have serious and sometimes life-threatening side effects.

With a 70% drop in sales, the manufacturer removed the device from the American market in 2018, and then did the same in other countries. Today, Essure is no longer sold anywhere in the world.

The ban, however, did not change anything in the daily lives of women who already had the device implanted. “For those who adapted well to Essure, there was no indication of any change,” says Politano.

It is important to say, the doctor points out, that there are women who had success with their implants and continue to live well with Essure today.

For some users of the method, definitive sterilization came with other permanent effects.

“I used to be an active woman with a normal social life, but I started experiencing pelvic pain, severe cramping, bleeding, breast and leg pain, and debilitating headaches. I also developed an allergy to nickel [material presente no dispositivo], a condition that greatly affects my life. It itches, hurts and causes unpleasant odors, which makes me feel self-conscious and isolated”, says Liliane Feitosa, 44, from Brasília, the capital of Brazil and the same city as Kelli.

Both women also report difficulty finding healthcare professionals who would take their symptoms seriously.

“Even after the ban, if I arrived at the hospital in pain, reporting all the symptoms, the doctors said it had nothing to do with Essure, and many of them were irritated. Even though many of them didn’t even know the method. No they knew, for example, how it was implanted or whether it could be removed”, explains Kelli.

She says she felt constantly humiliated, and, when she went to the emergency room, she discovered that other women were also going through the same thing in her city, Brasília, the capital of Brazil.

“I created an association, Vítimas do Essure – Brasília, to support each other and exchange information.”

“The Association provided psychological support that we had not previously found in health services”, says Shely Frazão, 40, who ended up looking for private clinics for her treatment.

The Health Department of the Federal District, responsible for the HMIB (Hospital Materno Infantil de Brasília), which performed the implants in Kelli, Shely and Liliane, told the report that at the time of insertion, the device was authorized by Anvisa, in addition to being used worldwide.

The ministry also stated that patients who had the Essure system implemented are monitored in the public health network. A specific guide was created for DF health professionals to monitor these patients, who have the right to have their uterus removed if they wish.

Bayer maintains that the device is safe.

“The safety of Essure is supported by a robust set of scientific study data. This data includes the results of 10 clinical studies and more than 70 real-world observational studies by the company and independent researchers over the past 20 years, involving more than 270 thousand women”, he told BBC News Brasil.

Bayer says the U.S. settlement reflects a business decision driven largely by the unique aspects of the U.S. mass tort system and taking into account the high costs of litigation in the country.

“In the cases resolved in the USA, there was no recognition of transgression, guilt or responsibility on Bayer’s part in the agreements. In recent months, Bayer has obtained a series of favorable decisions in Brazil. These decisions are in line with the company’s defense based on science regarding the safety and effectiveness of Essure”, he told the reporter.

Fight for compensation

Shely, who also suffered from similar effects to her fellow members, underwent a total hysterectomy, which included the removal of her uterus, cervix and tubes, as well as the extraction of the Essure device, in early 2023.

“It was an abdominal surgery similar to a cesarean section, although I had never had a cesarean section before, as my previous births were normal. During my recovery, I developed intestinal adhesions that caused severe obstructions. I needed to undergo another surgery in March 2023, which took me to the ICU.”

Liliane was about to undergo the same surgery, but discovered a grade three injury, which will need to be treated first, in her uterus.

Kelli got it removed, but she also had problems.

“In 2017, when I went to the hospital for removal, the doctor assured me that I wouldn’t need to remove the uterus. I believed it and did so.”

But the pain persisted, which led Kelli to believe the device may have fragmented or caused chronic inflammation.

“I had to undergo another surgery, at the private hospital. This time it was a total hysterectomy.”

The three women intend to sue Bayer, following the example of what was done in the United States — the pharmaceutical company paid US$1.6 billion (R$8 billion) to end practically all Essure lawsuits in the US — and in Australia — where more than a thousand women joined a class action lawsuit this year, alleging that the device caused pain, suffering and severe bleeding.

To date, however, only Kelli has obtained all the documents that her lawyer considered necessary to file the lawsuit.

“We allege that the Essure product is defective. Ms. Kelli’s intention in the lawsuit in question is to seek financial compensation for all physical and emotional damages caused as a result of the use of the device,” said Érico Rodolfo Abreu de Oliveira, lawyer from Todde Advogados and representative of Kelli’s case, to the report.

Bayer asserts that the US settlement reflects a business decision driven primarily by the unique characteristics of the US mass litigation system and considering the high legal costs in the country.

“In the cases resolved in the United States, there was no acknowledgment of guilt, failure or responsibility on the part of Bayer in the agreements. In recent months, Bayer has obtained a series of favorable decisions in Brazil. These decisions are in line with the company’s defense with based on science regarding the safety and effectiveness of Essure”, Bayer informed BBC News Brasil.