Blog Post

EU Temporarily Suspends Essure Implants

The "E-Sisters" - women harmed by Essure - are fighting for justice and to get the word out about the dangers of the device.

The sale and implantation of the permanent birth control device, Essure, which has led to the death of at least four women and causes pain so severe some women report becoming suicidal, has been suspended in the EU for three months pending additional information.

The Daily Mail is reporting on the decision by The National Standards Authority of Ireland to suspend implantation of the device which consists of a small coil that is implanted in a woman’s fallopian tubes. Manufactured by Bayer, the non-hormonal device causes the build-up of scar tissue that prevents eggs from reaching the uterus. This sterilization procedure is said to be 99.3 percent effective. However; the side effects are pain that can be so severe it can be crippling and has led some women to consider suicide.

Unfortunately, the only way to remove the device is by removing the oviduct or performing a hysterectomy.

Essure problems aren't limited to the UK. In the United States, more than 15,000 women have reported complications to the FDA which include pain, allergic reactions to the nickel and polyester components of the device, and dislodging of the coil that can then embed elsewhere in the body. Four deaths are associated with the device as well as 300 miscarriages.

The problems with Essure are so severe that the Facebook group, Essure Problems, has become a hub for thousands of women who suffered from the device.

More and more are speaking out about the problems with this device.  A recent interview on the BBC’s Victoria Derbyshire program, featured a woman named Laura Linkson, who was fitted with Essure in 2013 and who said the pain she experienced after the implantation left her suicidal and feeling like a burden on her family.

“I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal,” Linkson said.

Another patient, Victoria Dethier, who was implanted with Essure in 2012, suffered pain for three years before having a hysterectomy to remove the device in 2015.

She said: 'It felt like I was dying, like something was killing me from the inside.'

After the device was removed, Dethier said she instantly felt better. The pain was gone, as was the horrible taste in her mouth. She also began to grow back her lost hair.

“The Medicines & Healthcare Products Regulatory Agency has been criticized for failing to respond to the evidence surrounding the device's risk,” the Mail reports. “It also rejected the Victoria Derbyshire show's Freedom of Information request asking how many women have reported complications.”

Even though the UK’s National Health Service (NHS) says it doesn’t have figures for the total number of women who have been fitted with Essure or who had the device removed, a 2015 study found that women who had the implant were 10 times more likely to need follow-up surgery than those who had traditional sterilization.

A Bayer spokesperon told MailOnline: “Bayer was informed by the Notified Body National Standards Authority of Ireland (NSAI) on August 3rd, 2017 about a temporary suspension of the CE Certificates for Essure for a period of up to 90 days. Bayer has been working with NSAI and providing responses to their queries related to the renewal of the certificates. The temporary suspension of the Essure CE Mark is not related to product safety or quality issues . . . The recommendation to temporarily suspend clinical use does not constitute a recall.”

The spokesperson insisted that clinical evidence demonstrates a “favorable benefit-risk profile for Essure” and continues to stand behind the product “as an option for women who desire permanent birth control.”

Despite the company's equivocation, women on this side of the pond are rallying around the Medical Device Safety Act, H.R. 2164, a bill introduced by Congressman Brian Fitzpatrick (R-PA) and co-sponsored by Rosa DeLauro (D-CT) and Louise Slaughter (D-NY) which will reform the review process for medical devices and increase access to legal recourse for victims of unsafe devices.

Under current law, the manufacturer cannot be held liable for deaths or the harm and suffering the device has inflicted upon tens of thousands of women. The Medical Device Safety Act resolves this injustice and will allow victims of Essure—or any future device that causes severe injury or death—to seek legal recourse. This will incentivize device manufacturers to produce the safest and most effect products for all patients.

On September 25, 2017, advocates for changes in the laws pertaining to these devices will be rallying and lobbying in Washington for the passage of the bill. The rally is being sponsored by the Essure Problems Group and the Breast Implant Victim Advocacy Group. More information can be found on the Essure Problems Facebook page.

Despite the many health risks associated with the artificial contraception available today, too many women are not getting this information and are falling victim to a host of dangerous drugs and devices designed to either temporarily or permanently sterilize their reproductive capacity. This has led to many of the abuses predicted by Pope Paul VI in his encyclical, Humane Vitae.

“It is also to be feared that the man, growing used to the employed of anti-contraceptive practices, may finally lose respect for the woman and, no longer caring for her physical and psychological equilibrium, may come to the point of considering her as a mere instrument of selfish enjoyment and no longer as his respected and beloved companion," Pope Paul wrote.

Many women regard these warnings and prohibitions as archaic and accuse the Church of trying to tell them what to do with their bodies, but this attitude fails to realize the source of the truths that the Church is preaching.

“They are not our ideas, they are God’s ideas,” writes Rosalind Moss in the Full of Grace: Women and the Abundant Life Study Guide. “The Church has not right to invent truth, nor can it. But it has been given the mandate to deliver God’s truth, to teach the faith once delivered to the saints and handed down in an unbroken line of apostolic succession for 2,000 years.”

As she discovered during her own experience of conversion from the Jewish to the Catholic faith, obeying the Truth really can set us free to be all that God created us to be – “happy, and fruitful, and to have a life more wonderful than you could ever have imagined.”

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