Women lef t in agony by controversial NHS sterilisation implant

HOSPITALS have been asked to stop using a common sterilising device after claims it has left women needing hysterectomies.

The Essure implant is offered to around 1,500 women a year as a permanent sterilisation method that only takes ten minutes to insert without surgery or general anaesthetic.

But manufacturer Bayer has asked British hospitals to stop using the implants after sales were suspended in the EU earlier this month. It insists the suspension is temporary and that the implants are safe – but scores of women have complained of side effects, pain and complications, including the device perforating the womb or colon.

The implant is a titanium coil that is placed in the fallopian tubes, causing inflammation and triggering scar tissue to grow and block off the tubes, which stops eggs reaching the womb.

But US scientists spoke of a ‘serious safety concern’ two years ago and the UK’s medicines regulator – the Medicines and Healthcare Products Regulatory Agency (MHRA) – has been criticised for not acting on complaints.

Research led by Cornell University in New York and published in the BMJ in 2015 said women given Essure were ten times more likely to need later surgery than if they had undergone standard surgical sterilisation. The US’s Food and Drug Administration is reviewing Essure after receiving around 15,000 complaints.

The extent of the problem in the UK is unknown but an investigation by the BBC’s Victoria Derbyshire show found evidence of serious side effects that meant some British women were forced to have hysterectomies to remove the devices.

Speaking on the show, Victoria Dethier, who was fitted with Essure in 2012, said she was angry that women who complained were not being taken seriously. ‘There were moments where I couldn’t get out of bed I was in so much pain,’ she said. ‘It felt like something was killing me from the inside.’ She suffered for three years before realising what was wrong and having the device removed.

Laura Linkson, 34, from Southhighly ampton, said pain from the implant, which was fitted in 2013, left her feeling suicidal. She had the device removed but fragments were left behind, meaning she eventually had her entire uterus removed earlier this year.

She told the Mail she was initially dismissed by doctors, adding: ‘The pain drove me demented. I felt like my whole body was falling apart.’

Bayer said the suspension was related to administrative issues around its CE Mark – a certificate required to show it complies with EU standards – and was not related to product safety or quality issues. It said the evidence showed the benefits of Essure outweighed the risks.

A spokesman added: ‘The recommendation to temporarily suspend clinical use does not constitute a recall. Patient safety is Bayer’s top priority and Bayer UK stands behind Essure as an option for women who desire permanent birth control.’

An MHRA spokesman said there was no evidence of any increased risk to patient safety.

‘Pain drove me demented’