The Guardian view on vaginal mesh implants: trust data and patients
The devices have benefited a large number of women – but thousands have suffered serious adverse effects.
The numbers tell their own tale. Thousands of women have undergone surgery to have vaginal mesh implants removed after suffering complications. Around one in 15 of those fitted with the most common type of mesh have required operations, according to NHS data obtained by the Guardian. In short, the problems are much more widespread than previously acknowledged. The removal rate was previously estimated at less than 1%.
But numbers are not enough. Each case is a woman with a disturbing story; and listening is as important as tallying them. Carolyn Churchill had to give up work after she was left in agony, with persistent bleeding. Yet she said she was made to feel like a baby for complaining. Others describe being left unable to walk or have sex – and of being assured that the implant was not responsible. So even this data under-represents the problem. Women may not be referred for removal, or may decide against it given the risks.
The implants have been adopted widely as a simple, less invasive alternative to traditional surgical procedures for women suffering from incontinence and prolapse, often after childbirth. That the procedure saved the NHS a good deal of money no doubt helped. But doctors believed it was in the interests of their patients. In most cases, they were right. In too many, they were not.
The approval process for medical devices is poorly regulated in comparison to drugs: no large-scale, randomised controlled trials are required, and products can be introduced to the market rapidly – while complications may emerge only months or years later. It is time to consider a tighter regime. In the meantime, requiring long-term follow up studies to identify problems down the line could save patients suffering, without in any way holding back innovation.
But those shortcomings do not fully explain why such severe effects, reported by so many, in several countries, have gone under the radar for so long. Some of those may be procedural – the specialists implanting the mesh saw the successes, but were often not the ones removing it when things went wrong. But it is also clear that many sufferers simply were not listened to.
Of course, patients of both sexes can be brushed aside by doctors who think they know best. And many medical staff – both male and female – have been fighting for those affected: one recently compared the issue to the thalidomide scandal. But it echoes a pattern we have seen more broadly where women’s reproductive systems are concerned, such as in the extraordinary neglect of endometriosis. Women find that severe suffering is not taken seriously, or is misdiagnosed not once, but serially.
Authorities are at last starting to listen. The Scottish government has asked health boards to suspend the use of mesh devices; the US Food and Drug Administration has issued safety warnings about the risks. Meanwhile, an NHS review last month acknowledged that some women have suffered severe and life-altering complications, and called for patients to be fully informed of the benefits and risks of the procedure. But it concludes that the use of the implants is safe. This would be more convincing if it did not also call for more data – apparently oblivious to the evidence in its own records. The unearthed figures tell a more complex story, and so do the patients.