Contraceptive implant Essure could be safe after all

A contraceptive implant that has driven scores of women to the brink of suicide could be safe after all, a major study suggests. 

Essure, a controversial sterilisation device, has come under fire in recent years amid claims the form of permanent birth control leads to crippling pain.

But new data, of more than 100,000 women, suggests women who undergo the scandal-hit procedure face a lower risk of problems straight away.

Researchers found women who got the Essure implant faced a 0.13 per cent risk of immediate complications – six times less than surgery.  

The French government analysis, published in JAMA, comes just months after Essure was withdrawn from sale across the world – apart from in the US.

The study, which used data from women who had undergone sterilisation between 2010 and 2014, backs up claims by the device manufacturer that it is safe.

But the French National Agency for Medicines and Health Products trial showed the Essure product is eight times less effective than traditional surgery.

The controversy surrounding the device, which has escalated rapidly, has led to protests in the streets outside medical conferences. 

It was temporarily suspended in the EU in August last year and hospitals in the UK were urged to avoid using the devices.

Bayer, which manufactures the controversial implant, pulled the product from the market completely. It is only available in the US.

However, the drug firm denied that its actions were due to Essure being deemed unsafe, and insisted the removal was for commercial reasons.  

In a statement released on its French website at the time, Bayer said no faults have been found in 10 years of scientific research.

The new research, based on statistics of French women who underwent sterilisation between 2010 and 2014, backs up the firm’s claims.

A third were given the Essure device, while the rest underwent surgery – the more traditional method, known as having ‘tubes tied’. 

Dr Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, wrote an editorial that accompanied the study.

She said: ‘I do hope calmer minds will prevail and we don’t lose a very valuable technique that’s helped lots and lots of women.

‘My concern is it won’t matter what women think or what the research says. If the product goes off the market, it’s gone.’

Dr Charles Ascher-Walsh, director of gynecology and urogynecology for Mount Sinai Hospital in New York City, warned the results ‘won’t change much’.

‘This will give a little bit more evidence to us when we’re trying to let a patient know it’s not as bad as it sounds, but it’s one chord in a long tune of negativity,’ he said.

Bayer claims Essure, a permanent birth control method, is 99.3 per cent effective in preventing pregnancies.

However, the French National Agency for Medicines and Health Products in Saint-Denis, data showed that it didn’t work for 4.8 per cent of patients.

The risk was just 0.69 per cent for laparoscopic surgery, according to the study that was led by Dr Kim Bouillon. 

Essure implants can be placed into women in less than 15 minutes, making them an ideal option for surgeons before evidence began to mount over their dangers. 

More than 15,000 women have reported complications from their Essure in the US to the FDA, including pain, allergic reactions and ‘migration of device’.

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

And the Medicines & Healthcare Products Regulatory Agency has previously been criticised for failing to respond to the evidence surrounding the device’s risk.

It also rejected a Freedom of Information request by the BBC’s flagship Victoria Derbyshire show last August how many women have reported complications.

HOW BAD IS THE PAIN CAUSED BY THE ESSURE BIRTH CONTROL DEVICE? TWO WOMEN REVEAL THEIR AGONY AFTER PROCEDURE

Laura Linkson, who was fitted with the controversial Essure device in 2013, said last August that the pain left her suicidal and feeling like a burden on her family.

Speaking on the BBC’s flagship Victoria Derbyshire programme, she said: ‘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.’ 

Laura Linkson was fitted in 2013 and said the pain left her suicidal and a burden on her family

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 devices’ removal, Ms Dethier says she instantly felt better, with the horrible taste in her mouth easing and her previously lost hair growing back within just 12 months.

Victoria Dethier had the implant in 2012 and suffered pain for years before her hysterectomy

Essure is a permanent birth control procedure that involves inserting a tube into women’s fallopian tubes.

The device went onto the market in 2002, but more than 34,000 women across the world have complained of side effects in the years since. 

In the US, around 15,000 women have reported complications to the FDA, including pain, allergic reactions and ‘migration of device’. 

The programme followed the stories of two British women who were left in crippling pain from the device, which consists of two coils.

Laura Linkson, who was fitted with Essure in 2013, said the pain left her suicidal, unable to move and feeling like a burden on her family. 

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.

After the devices’ removal, Ms Dethier told reporters that she instantly felt better, with the horrible taste in her mouth easing. 

Essure is a coil implant that triggers inflammation in the Fallopian tubes, resulting in the build-up of scar tissue that blocks eggs from reaching the womb.

But in some cases, the device has been accused of puncturing holes in the Fallopian tube, and even becoming dislodged before embedding elsewhere in the body.

Some women, it is claimed, also react badly to the devices’ materials, which include nickel and polyester. 

Due to the how the coil attaches to the fallopian tubes, it can only be removed by taking out the oviduct or, in some cases, performing a hysterectomy. 

A spokesperson for Bayer said the firm believes it is ‘critically important that women’ are armed with ‘factual, unbiased information’.