Health This article is more than 6 years old'Scandal' of vaginal mesh removal rates revealed by NHS records
This article is more than 6 years oldTraumatic complications mean one in 15 women fitted with the most common type of mesh support will require surgery to extract it, figures suggest
Vaginal mesh implants: ‘I really thought I was dying’
Thousands of women have undergone surgery to have vaginal mesh implants removed during the past decade, according to NHS records that reveal the scale of traumatic complications linked to the devices.
The figures, obtained by the Guardian, suggest that around one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted due to complications.
Sohier Elneil, a consultant urogynaecological surgeon at University College Hospital, London, who has carried out hundreds of removal procedures, described the removal rate as a “scandal”, adding that these patients were likely to represent those with more serious complications.
Another surgeon, Mark Slack, a consultant gynaecologist at Addenbrooke’s Hospital Cambridge, who has previously defended the benefits of mesh surgery, said he was “absolutely shocked” by the failure rate, although he questioned whether the figures for complete removals could be an overestimate.
The implants have been widely used as a simple, less invasive alternative to traditional surgical approaches for treating urinary incontinence and prolapse, conditions that can commonly occur after childbirth. For the majority of women the operation is successful.
However, concerns are mounting over the severe complications suffered by large numbers of patients, including chronic pain, mesh cutting through tissue into the vagina and being left unable to walk or have sex. Johnson & Johnson, whose subsidiary Ethicon produces one of the most widely used mesh products, is fighting a major class action in Australia and could face legal proceedings in the UK.
In 2014, the Scottish health secretary wrote to health boards requesting they suspend the use of mesh devices, and the US Food and Drug Administration has issued safety warnings about the risks of mesh surgery. The NHS maintains that the available evidence supports the continued use of the devices to treat incontinence, but its own records raise questions about whether some patients are being exposed to unacceptable risks.
NHS Digital records show that between 2006 to 2016 just over 75,000 trans-vaginal tape (TVT) implants – the most common kind – were fitted. During the same period, more than 4,900 procedures were carried out to remove TVT implants – around 6.5% of the number put in.
More than 1,000 removals were also carried out for a second type of mesh, called transobturator tape (TVT-O), which had been inserted into 44,000 women over the ten year period. Johnson & Johnson are understood to produce the majority of vaginal mesh products used in the UK.
The figures imply much higher complication rates than those typically reported in both short-term clinical trials and a 2014 government report assessing the risks and benefits of vaginal mesh, which estimated the removal rate for TVT at 0.9% and the rate of complications, such as pain, at below 1.5%.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, said: “What this is showing is significant, very high rates of removals, which are only likely to get worse. It suggests that one in 15 women will need a removal at some point.”
TVT implants have been widely used across Europe and in the US since the early 2000s, when they started to be favoured over traditional open-surgery procedures, which took longer to perform, involved a lengthier recovery for patients and were associated with their own range of complications. A TVT procedure typically takes 3o minutes and is performed using keyhole surgery. Patients often go home the same day and trials have found impressive success rates for resolving incontinence.
Elneil said that many patients believe the procedure will be a “simple and easy fix” for a distressing problem. “A lot of patients weren’t worried, they thought: ‘I’ll be back in work next week,’” she said. “The removal is a completely different story.”
After being placed in the body, the plastic mesh becomes embedded in the surrounding tissue and is designed to be permanent. Full removal can require hours of surgery and can risk damage to nerves and nearby organs, including the bladder and bowel. According to NHS figures, 1,769 complete removal procedures have been carried out since 2006.
Slack explained: “You go in vaginally and take out the mesh there, then you go in through the tummy and chisel out the mesh with some difficulty. It’s very much not within the skill mix of the vast majority of surgeons.”
The surgeon said that the figure for partial removals (3,137 since 2006) is consistent with his clinical experience that “we are taking out snippets of mesh here, there and everywhere on a weekly basis”. However, he questioned whether the figures for complete removals, which are far higher than he expected, could be an overestimate due to misreporting by doctors.
Yet a recent survey of UK gynaecologists appears to support the NHS figures.
In a statement, Johnson & Johnson said: “We empathise with those patients who have had complications associated with pelvic mesh procedures, but we believe it is important to recognise that their experiences do not speak for the vast majority of women whose lives have been improved through treatment with pelvic mesh devices.”
The Medicines and Healthcare products Regulatory Agency (MHRA) said no device was without risk. It added: “In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of evidence which would lead to the conclusion these devices are inherently unsafe if used as intended.”
If you are a woman who has experienced problems with a mesh implant, these can be reported to the MHRA. The British Society of Urogynaecology has compiled a list of units with experience in treating mesh complications.
This article was amended on 16 August 2017. An earlier version said in Scotland, the use of mesh devices was suspended in 2014 pending a review. In fact the Scottish health secretary wrote to health boards requesting the suspension of mesh devices in 2014, although some hospitals in Scotland still use mesh implants.
ncG1vNJzZmivp6x7tbTEoKyaqpSerq96wqikaKufmLamwNhoaWlpZ2SutrOOamxoq5OWu6Wty2amn2WmlrSqusClZKado516s7HMqK2apF2nrrWx0mapnq6VlrmmsIybsGammKh6s7HCqKmdqw%3D%3D