Advising with empathy and experience

Hysterectomies for some women fitted with Essure.


Many women are having to have hysterectomies to remove a sterilisation device used on the NHS.

The Essure implant is used to permanently sterilise women, but can cause side effects and complications.

One woman - who later had her uterus removed - said she was left suicidal due to the "unbearable" pain, and felt she was a burden to her family.

The manufacturer, Bayer, says Essure is safe and the benefits outweigh the risks but the sale of the implants in the EU was temporarily suspended at one stage.

One patient, Laura Linkson, who was fitted with the Essure device in 2013, said the pain left her suicidal.

"The device was sold to me as a simple and easy procedure. I was told that I'd be in and out of the doctor's office in 10 minutes and that there'd be no recovery time. I went from being a mum who was doing everything with her children, to one who was stuck in bed unable to move without pain, at some points being suicidal. I felt like I was a burden on everyone around me."

The small coil implants, made from nickel and polyester (PET) fibres, are used as a sterilisation device to stop eggs reaching the womb.

They are inserted into the fallopian tubes where they trigger inflammation, causing scar tissue to build up and eventually block the tubes, known as a hysteroscopic sterilisation.

The devices can cause intense pain, and some women are thought to react badly to the nickel and plastic. Because of the way the coils attach to the fallopian tubes, they can be extracted only by removing a woman's fallopian tubes and often her uterus.

In other cases the device has been found to perforate a fallopian tube and dislodge, embedding itself elsewhere in the body.

Another patient, Victoria Dethier, had an Essure fitted in 2012. For three years she could not work out why she felt so unwell.

She said: "There were moments where I couldn't get out of bed I was in so much pain. It felt like I was dying, like something was killing me from the inside." She had a hysterectomy to remove the device in 2015.

She added: "Straight away there was a difference, I'd experienced a horrible taste in my mouth and that went. I'd lost a lot of hair and that came back within 12 months, it was incredible."

The medicines and healthcare products regulatory agency (MHRA) has been criticised for not responding to the increasing allegations about the effects of the device.

A study published in the British Medical Journal (BMJ) in 2015 suggested that women who had a hysteroscopic sterilisation are 10 times more likely to need follow-up surgery than those who had a traditional sterilization.

In the US more than 15,000 women have reported problems including pain, allergic reactions and "migration of device" to the US Food and Drug Administration (FDA).

Director of the Centre for Evidence-Based Medicine at Oxford University, Carl Heneghan, has criticised the regulator's failure to act on such findings asking how much evidence is needed before the product is withdrawn from the market.

The NHS does not have figures for the total number of women who have been fitted with Essure, or who have had it removed.

However, the clinical trial that led to the device being approved has been criticised for not considering the long-term effects of the implants.

Mr Heneghan said: "The trial followed up women for only one year, so nobody has a real understanding of what happens with this device after two, three or five years."

Some women who have experienced problems say they were not informed about the risks.

Consultant obstetrician and gynaecologist Ben Peyton-Jones, said the device should still be used in some instances.

He said: "I think it has a place for women who can't have keyhole surgery and who are explained the risks very carefully. When used correctly, according to the manufacturer's guidance and in trained hands, it is safe."

Bayer said that independent reviews of Essure had concluded that the benefits outweighed the risks.

In a statement the company said: "Patient safety and appropriate use of Essure are the greatest priorities for Bayer, and the company fully stands behind Essure as an appropriate choice for women who desire permanent contraception. Many women with Essure rely on this form of contraception without any side effects."

The MHRA said it had no evidence to suggest this product was unsafe, and that the recent suspension did not suggest any increased risk to patient safety.

It said it was important for healthcare professionals to discuss the risks with patients before a procedure.






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