After U.S., women in Brazil seek damages over birth control implant

But Cavalcanti’s experience with Essure was anything but good, she said. The contraceptive device, she alleges, left her in agony, with symptoms including headaches, chills and bleeding.

She wasn’t the only one. By the time Cavalcanti realized what was happening, she said, tens of thousands of women across the globe had said they were going through the same thing, according to allegations in lawsuits. Their symptoms were vast and relentless, they alleged — including uterine perforation, ectopic pregnancy, abdominal pain so severe it affected mobility, depression and suicidal thoughts.

When Cavalcanti saw that women in the United States joined a class-action lawsuit — which would result in a $1.6 billion out-of-court settlement in August 2020, but without admission of liability from Bayer — it got her thinking.

“Essure destroyed my life and the lives of so many other women,” Cavalcanti said. “No money in this world will give me my life back. But I think, from here forward, we all deserve a bit of dignity and to be able to take care of ourselves.”

Now, more than 380 of the thousands of women in Brazil who say they suffered severe physical and emotional effects because of Essure are seeking damages from Bayer. They hope the company will acknowledge what they allege is an error in not pulling the product from the international market until September 2017, years after serious complaints first started to accumulate.

In a statement, Bayer Brazil said the company “continues to stand behind the safety and efficacy of Essure, which is supported by a robust body of scientific study data.”

The U.S. Food and Drug Administration granted premarket approval for Essure in 2002. By 2013, serious complaints about the metal coils had started to roll in.

According to the Wall Street Journal, the first litigation against Bayer in the United States started around 2014 — the same year Cavalcanti gave birth to her youngest child in São Paulo, Brazil.

When Cavalcanti informed her doctor it would be her last pregnancy, she was given one option by the doctor, she said: Essure, metal coils inserted permanently into the fallopian tubes that block sperm from reaching the egg.

The device had been approved for use by Brazilian health regulatory authority Anvisa in 2009. According to an out-of-court demand letter sent to Bayer by attorneys for women in Brazil, Essure was promoted with posters and leaflets that prominently displayed the Bayer logo, and received substantial attention because of its inclusion in a family planning program run through the country’s public health-care system, known as SUS.

The program, the letter alleges, included informational sessions with health-care professionals in which patients were given consent forms based on Essure product inserts. Those inserts, according to the women’s attorneys, said there was less than a 0.05 percent chance of infection, displacement of the device or perforation of organs.

Based on this information, medical staff also recommended Essure on TV and in posts shared on YouTube by Commed, the company in Brazil that imported and distributed Essure on behalf of Bayer, which promoted the device as safe, effective and painless.

In an email statement from December, the Ministry of Health said that while Essure was available in some public health facilities, “SUS is tripartite and, therefore, local health managers have the autonomy to purchase supplies that are not part of the list of contraceptives made available by the Ministry of Health.”

For Cavalcanti, Essure sounded like a dream; she was told the procedure would be quick and easy, she said. With four kids and a home to care for, as well as a full-time job to get back to, taking the time to recover from surgery for a tubal ligation would be almost impossible.

But the pain she felt during her 2015 procedure was unbearable, she alleges. After having the coils placed, the flow of her menstruation became heavier and it continuously lasted longer until there were only three days in a month where she wasn’t bleeding, Cavalcanti said.

Then other symptoms started to emerge, according to Cavalcanti: chills, sweats, headaches, swelling in her belly and legs, and pain throughout her body. Her skin became patchy and dry, and her teeth so weak that some fell out, she said. She said that she also developed fibromyalgia, a disorder that causes widespread muscle pain and tenderness, fatigue, and altered sleep, memory and mood.

That year, the FDA held a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee after receiving thousands of complaints about the device, including reports of adult and infant deaths or pregnancy loss. (The FDA said it cannot determine from the reports if the device caused the deaths.) In February 2016, it requested a new study be conducted to gather more data about Essure’s benefits and risks, in addition to clinical trials that were conducted before the product was being marketed. Eight months later, the U.S. regulatory body placed a warning label on the contraceptive coils.

Over the next two years, health authorities in other countries took action. In Canada, Bayer was required to change labels and notices on Essure, and a three-month sales ban was imposed in the European Union.

Anvisa demanded in June 2016 that Commed submit a clinical study, an updated risk management report and a list of actions taken in response to warnings from regulators in other countries. When, in February 2017, Commed still had not complied, Anvisa banned the importation, sale, distribution and promotion of Essure and ordered it recalled. (Commed was acquired by another company in 2019.)

Following further voluntary recalls in Finland, Canada and the Netherlands, Bayer stopped all Essure sales outside the United States in September 2017. By the end of that year, the number of complaints registered by the FDA reached 26,000. Bayer also announced in July 2018 that it would discontinue the sale and distribution of Essure in the United States by the end of the year, denying repeatedly that it was dangerous or caused injuries.

In response to questions about its settlements with women in the United States, Bayer Brazil said in an email that it “reflects a commercial decision driven in large part by the unique aspects of the US mass tort system, including the high costs of US litigation,” and that “there is no admission of wrongdoing or liability by Bayer in the settlement agreements.”

While Anvisa and the FDA reviewed the safety of Essure, Cavalcanti continued to ask for answers from medical professionals but received none, she said. She was given a prescription for birth control pills to regulate her menstrual cycle, but doctors ignored the rest of her symptoms, she said. In 2017, she ended up having a hysterectomy, removing her uterus and fallopian tubes.

That’s when Cavalcanti started doing her own research online. There, she found a Facebook group for women in the United States who said they suffered from a long list of debilitating symptoms, some of which were the same she had experienced since agreeing to have the birth-control device inserted. Those women also blamed Essure.

By that time, Bayer was facing thousands of lawsuits and claims.

Cavalcanti was inspired.

She knew she couldn’t be the only one going through this in Brazil, because Essure was offered through SUS. Patients who received the device came largely from disadvantaged communities on the outskirts of major cities such as São Paulo, Rio de Janeiro and Brasília, according to attorneys for the women.

When she started her own Facebook group in March 2017 for Brazilian women, the number of members quickly started to rise, reaching more than 1,700 in total.

One of those women is Rosa Germano. In 2014, Germano decided she didn’t want more children. She said she was told Essure was her only option, and in September 2015 she was called in to Rio de Janeiro’s Mariska Ribeiro Women’s Hospital for the procedure.

Afterward, she said, she suffered devastating pelvic and joint pain, irregular periods and hair loss, among other symptoms. After some of her symptoms didn’t subside and she developed cysts, she too had a hysterectomy, first removing her fallopian tubes in September 2019 and then her uterus seven months later.

In an email statement, Rio de Janeiro’s Municipal Secretariat of Health, responsible for the public hospital, said that once Bayer pulled Essure from the market, the Mariska Ribeiro Women’s Hospital “made a specialized team available to monitor these women,” and that of the 3,642 women who had the device inserted, about 440 returned and had it removed. It also said it “continues to attend to all patients who report complications and are interested in removing the device.”

Germano said that meeting other women online who were going through the same thing made her realize she wasn’t alone in her pain.

“I saw that what I was feeling wasn’t something in my head,” Germano said. “It wasn’t just going to take time to adapt to the device. It really was a rejection. It was my body reacting to something that shouldn’t have been there.”

Now, Cavalcanti and Germano are two of 387 people represented by PGMBM, an international law firm created through a partnership among British, Brazilian and American lawyers that take on large-scale group litigation against big corporations accused of mistreating, misleading or injuring people. Their attorneys, including Bruna Ficklscherer, decided to take their legal complaint to the Bayer parent company in Germany because Brazil’s legal system is known for being bogged down in bureaucracy.

An out-of-court demand letter was sent to Bayer on July 23, 2021, and the company replied Sept. 1. Discussions between attorneys for Bayer and the Brazilian women are ongoing. When asked about a possible resolution, Bayer said that “given the possibility of lawsuits, it would not be appropriate to comment further on our communications.”

Ficklscherer said her team hopes to agree on a settlement without going to court.

Women like Cavalcanti and Germano say a settlement payment could mean a step toward getting a small piece of their lives back. Some medical tests and procedures aren’t covered or have long waiting lists in the public health-care system. Being able to afford a private health-care plan might take some of their physical pain away, they say.

“We want reparations that are fair,” Germano said. “So that we can take care of our health for the rest of our lives. Because we know our health will never be the same.”