The terrible side effects of the ‘most effective contraceptive in the world’

How a small nickel coil can turn your life into a living hell

When Carolina Hernández decided she didn’t want any more children, she started looking for a method of contraception that was effective and non-invasive.

A quick internet search was enough to find what appeared to be the perfect solution: a tiny coil, developed by Conceptus Inc. – a subsidiary of Bayer AG – inserted in the fallopian tubes. It was an apparently revolutionary invention. ‘In the hospital they told me that it was wonderful, that it didn’t have a single side effect, that it was 100% titanium. They said they’d insert it during a single appointment, and that the next day I’d be able to carry on living my life as normal.’

That was 2005. At first, everything seemed to go well enough. 

However, five years later, Carolina began experiencing a series of extremely unpleasant side effects. Painful periods; urinary infections; blood in her stool and urine; constant tiredness; and severe pain in her head, lumbar, knees, elbows, back, abdomen and bones – a generalised pain that prevented her from performing even the simplest of tasks.

Today, Carolina is one of 80,000 women who have been implanted with Essure since its launch in Spain in 2003, and one of 1,000 to have been negatively affected (according to the Spanish Association for Women Affected by Essure) by a form of contraception that is considered ‘the safest in the world’.

She is not the only one to suffer these side effects. Just over a week ago, Carolina Díez, another of the women affected, filed the first formal complaint in Spain about the contraceptive’s side effects. She blames the Spanish Ministry of Health, the National Health System and the Spanish Agency for Medicine and Healthcare Products (AEMPS) ‘for their failure to supervise and control the product, to evaluate the reports of incidents received, and to prepare informative health alerts.’

Her decision follows the recent prohibition of the implant in Brazil. And it forms part of the struggle that women from all over the world have been engaged in to ban Essure.

Because what many of these women have discovered is that ‘the world’s safest contraceptive’ is nowhere near as safe as they were led to believe.

I

The big controversy behind the tiny coil

Essure is the name of these little coils which are made from nickel (not titanium as Carolina was originally told). The coils are implanted in the fallopian tubes via the uterus. ‘The device causes local inflammation which obstructs the tubes and prevents fertilisation,’ say Dr Juan Gervás and Dr Mercedes Pérez-Fernández.

The advantages? Well, it’s supposedly much better than the previous alternative: tubal ligation. ‘It can be inserted in a single appointment with no need for anesthesia, hospitalisation or surgical intervention,’ explain Gervás and Pérez-Fernández.

It was introduced in Spain in 2001 and promoted as a ‘permanent and definitive method: almost 100% effective’. ‘We were dazzled by the novelty,’ says Enriqueta Barranco, a doctor who specialises in gynecology and obstetrics. Now, 16 years later, Dr Barranco believes that from a medical and professional point of view – and from the perspective of women’s health surveillance – ‘its introduction into the market was precipitated’ given all the complications that the device has presented.

II

Constant pain, diarrhea, painful periods and other side effects

Lourdes Peñarolla had the Essure inserted in 2006, at the age of 36. In 2007, she went into hospital suffering from pain in her pelvis. ‘At first, I had pains in my groin and kidneys, as if I had lumbago,’ she says. The situation grew worse as time wore on and Lourdes embarked on a series of visits to a variety of specialists, none of whom were able to give her an explanation for her pains.

‘It didn’t matter what I took; nothing helped. My body ached. I had pains, contractions… my pelvis hurt and I couldn’t walk. I suffered extreme fatigue and got anxiety attacks thinking about how I – a young woman, in my early forties –  was unable to do anything. I found it hard to get out of bed, get dressed and take my daughter to school. I spent all day in the bathroom with diarrhea. These last two years have been awful,’ she says.

‘It didn’t matter what I took; nothing helped. My body ached. I had pains, contractions… my pelvis hurt and I couldn’t walk.’

44-year-old Gloria Quero tells a similar story. She still has the contraceptive device in her body. ‘I’ve had it since February 2006, but I’m having tests to see about getting it removed,’ she explained by telephone. ‘At first, I felt neck pains which I attributed to my job. But over time I began suffering digestive problems, indigestion, vomiting, muscular pains, anxiety, stress, dry eyes, and vaginal and urinal infections on a monthly basis. I felt unwell but I never equated it with Essure. There were so many different problems that I found it hard to believe a method of contraception could possibly be responsible for all of them,’ Gloria says.

‘As is frequently the case with medical devices, Essure was approved with fewer requirements than medicines,’ points out Gervás. Dr Julio Novoa, an American obstetrician who works in Meharry Medical College, El Paso (Texas) – and who is one of the most prominent anti-Essure activists in the US – concurs with Gervás.

‘The clinical studies carried out for the Essure device were extremely weak. The trials used to obtain market approval and access were based on non-random, non-blind studies with no control group, from a total of just 926 women. Although prospective studies were performed, a significant number of patients were withdrawn from the study or lost track of during the follow up, which affected the safety and efficacy assessment. Much of the data was gathered from phone surveys rather than a physical examination of the patient in a standardised environment by a physician,’ says Novoa.

Bayer, the company behind the Essure, defends its product by arguing that ‘scientific studies involving more than 14,000 women have been carried out with Essure – including clinical and post-authorisation studies. The five-year post-authorisation safety studies of Essure do not reveal any new safety problems, nor a higher incidence of known problems.’

I felt unwell but I never equated it with Essure. There were so many different problems that I found it hard to believe a method of contraception could possibly be responsible for all of them.
III

Problems with the device itself

To all the aforementioned negative side effects, we should add those related to malpractice during insertion of the device. These include the migration of the Essure coils to areas outside the fallopian tubes, and tubal perforation. 

‘When they examined me, they found that my Essures had migrated to the uterus. Of the 12 rings that each device contains, ten of one and eight of the other had travelled to the uterus. Despite that, doctors told me that there was no proof that it was the Essure that was causing me the pain,’ says Lourdes.

In Carolina’s case, the device travelled even further. ‘When I got an X-ray, they realised that I had three devices instead of two. Nobody had warned me about this, but apparently it doesn’t matter if they insert more than two devices,’ says Carolina. However, one of the coils travelled to the intestine and ended up staying there. ‘Every time I sneezed I’d feel it sticking inside me. That’s where the blood in my faeces and urine was coming from,’ she adds.

There are also cases of women who have suffered perforation of their fallopian tubes.

Every time I sneezed I’d feel it sticking inside me. That’s where the blood in my faeces and urine was coming from.

‘One of the features of Essure that always made me feel a little uncomfortable (although I didn’t really become concerned until problems began occurring) was that the method works by provoking inflammation, leading to the destruction of tube tissue,’ says Enriqueta Barranco. ‘Often during this process the tube tissue is punctured by the coil. Not only due to inexpert insertion, but also during the process of destruction of the intrafallopian tissue.’

‘It’s an aggressive method due both to the way it behaves inside the fallopian tube, and to the method of insertion. And insertion is very difficult unless the doctor is well trained,’ concludes Barranco.

This means that Essure presents up to ten times more of a risk of reoperation (due to problems in the insertion of the device) than tubal ligation does, as noted in this study published by the British Medical Journal in 2015.

On most occasions, surgery is the only way of ending the patient’s suffering. ‘After the operation all the pain was gone,’ says Lourdes. ‘My daughter said: “Mum, it’s like you’re a different person.” I had the device inserted when she was four, so she’d never known the real me.’ 

‘I got them to operate on me in September last year. Since I left surgery I haven’t felt any pain in my stomach or hips. I’ve even put on weight because now I can eat what I want,’ Carolina explains. ‘I feel like I’ve got my life back at last. Pain conditions the way you live.’

IV

99% effectiveness? Doubts about its efficacy

From the day of the product’s launch, Bayer has been busy promoting the Essure’s supposed effectiveness as a way of attracting customers. If you visit the Essure website, the first thing you’ll see is a banner that says ‘Essure is over 99% effective at preventing pregnancy.’ A statement that some critics don’t agree with.

‘After the operation, all the pain was gone. My daughter said: “Mum, it’s like you’re a different person.” I had the coil inserted when she was four, so she’d never known the real me.’ 
‘Although they say its almost 100% effective, there are doubts about its efficacy,’ say Dr Gervás and Dr Pérez-Fernández. These doubts are revealed in a scientific study published in Contraception Journal which compares the pregnancy rates in patients with Essure with those of patients with tubal ligation. The results revealed that the number of pregnancies was up to ten times higher for those with the coil.

V

Prohibitions, Black Labels and a lot of money spent on legal defence

So why do doctors continue implanting this device if it causes pain so often and does not even do what it’s supposed to? Why does nobody warn patients about the true nature of the product?

‘Over the past five years, there has been a fundamental change in public opinion, as well as in doctors’ practices when it comes to the quantity of Essure devices inserted in the US and around the world,’ says Julio Novoa. This awakening has resulted in a number of key actions.

The first: the so-called ‘Black Box’ by the FDA in the US. ‘In 2016, the FDA imposed a severe injury warning and drew up a list of possible damages that women must be made aware before they give their consent to have the device inserted,’ say Gervás and Pérez-Fernández.

Bowing to pressure from US organisations and civil society, the FDA forced Bayer, at the start of 2016, to carry out a long-term clinical trial of the device’s safety, efficacy and autoimmune reactions. On top of this is the ever-growing list of complaints that have been made against Bayer following the intervention of activist Erin Brockovich. ‘A review of the annual financial reports has revealed that Bayer has spent at least $415m in legal defence of the Essure device,’ says Dr Novoa.

Outside the US, Essure has already been banned in Brazil by ANVISA – the South American nation’s drug regulatory body – because of the high number of complications and malfunctions associated with the device. ‘While Holland – which promoted the use of Essure very actively at first – is now one of the countries that uses the device least,’ says Julio Novoa.

VI

What are affected women demanding in Spain?

Since March 2016, doctors in Spain must inform patients about the possible adverse effects of Essure and the protocol for withdrawing the device from the body. ‘In addition, SEGO (The Spanish Gynaecology and Obstetrics Society has recently issued a report about Essure aimed at both users and medical professionals,’ say Bayer.

Many affected women however, say that this is not enough. ‘The latest woman to join the Essure free platform had the device inserted on 17 January, and they told her exactly the same thing they told me when I had it inserted in 2005: that it was made of titanium, that it had no side effects, and that was that,’ says Carolina.

‘It’s very likely that many professionals ignored the SEGO report,’ says Enriqueta.

Gloria Quero, another of those affected, wants to improve the treatment of women like her. ‘If you go somewhere with a problem, and they treat you well and do what they’re supposed to do, then you go away happy. But if they’re constantly messing you around, hurting you, and treating you badly, then you’re going to have a lot of angry women,’ Quero says.

But the worst thing about all this medical mishandling is that women who wish to be operated on face a number of impediments. ‘The Essure can’t be removed without taking out the fallopian tubes,’ says Enriqueta Barranco. Women who decide to end their torment by going through surgery face a double trauma: the removal of part of their reproductive organs and the constant questioning of their symptoms.

‘I don’t agree with being told, “if you want me to operate, I’ll operate on you,”‘ says Gloria. ‘And then being made to sign a consent form which makes it sound like I’m only getting the operation because I feel like it and not because the device is causing me pain and making me seriously ill.’

‘I don’t agree with being told, “if you want me to operate, I’ll operate on you,”‘ says Gloria. ‘And then being made to sign a consent form which makes it sound like I’m only getting the operation because I feel like it and not because the device is causing me pain and making me seriously ill.’

In light of all this, there are more and more voices advocating for the world to follow Brazil’s lead and ban this method of contraception. Because, as Dr Gervás and Dr Pérez-Fernández have said: ‘Essure coils should never have been approved, should never have been used, and must be withdrawn from the market as soon as possible.’ To this end, a campaign was initiated on Change.org by the Spanish Association of Women Affected by Essure calling for the total prohibition of the method in Spain.

In the meantime, those affected by the device just want their suffering to end. Lourdes and Carolina have already been operated on and are starting to rebuild their lives. Gloria is eagerly awaiting surgery; ‘I’m looking forward to feeling better. The women who’ve already had the device removed have given me hope and encouragement that everything will work out in the end.’


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