Vaginal Mesh in the English Media
The English media comes round to the dangers of medical devices
The BBC's Woman's Hour and Face the Facts programmes have produced a set of broadcasts on vaginal mesh and its effect in the UK.
One woman who had been fitted mesh spoke of the debilitating pain she suffered, leaving her wheelchair-bound and temporarily unable to care for her children. Another said she was never warned about the potential 'cheese-wire effect' of the devices.
According to statistics, around 1% of vaginal tape cases result in difficult complication. However, mesh patches, although less commonly fitted than tape, have a complication rate of up to 20%, but receive less stringent regulation.
Under the EU regulatory system, there is often no need for clinical data to be made available for a device to be approved. 'Equivalence' is the regulatory standard: if a device is sufficiently similar to another, it can be approved for use within a couple of days. Regulators may not test or even see the product, simply relying on the literature provided by the manufacturer.
A review of mesh safety and regulation is currently underway, with results due to be published in the autumn of 2015. When the BBC asked one of the authors of the study whether she could advise on whether mesh devices were safe, she was forced to admit that she could not. Given the numbers of women being fitted with mesh products and their potential for serious damage, this is a shocking position.
Face the Facts
Drugs are extensively tested before release on the market, but surgical procedures and medical devices receive far less scrutiny. Calls for a national register of medical devices, to monitor their use and complication rates, have so far not met with great success. One expert, speaking to the BBC, said that
'People are actually the test, the clinical trial - but they aren't being informed.'
Vaginal mesh, according to some sources, will be looked back on as something the medical profession should never have used.
Michelmores' article on Vaginal Mesh in the UK, for the US site Mesh Medical Device Newsdesk, can be read here.
The BBC Face the Facts programme on mesh can be found here.
You can listen to an extract from the Woman's Hour programme here.
If you would like to discuss a claim relating to vaginal mesh products or any other medical devices, you can call us for free, for discreet, impartial advice.