The Surgical Mesh Scandal: Part Two

23rd January 2020 Clinical Negligence

Surgical mesh hit the headlines again last week after spending just nine months out of the limelight.

Last week a Freedom of Information request by the BBC’s Victoria Derbyshire programme revealed that many of the 100+ types of mesh purchased by the NHS between 2012 and 2018 had subsequently been implanted into patients during hernia repair operations with either little or no clinical evidence in support of their use.

 Many will recall the ‘vaginal mesh scandal’ which came to a head in July 2017 after senior doctors called for a public enquiry into its use. Prior to this, surgical mesh was routinely used to treat stress incontinence and pelvic organ prolapse in women after childbirth. In 2018 the British Medical Journal carried out an independent investigation and found that thousands of women had endured irreversible harm following implantation. The mesh was found to have perforated organs and cut into tissue and nerves, causing chronic pain and leaving many women unable to walk.

A ban on its use was implemented, only for it to be lifted in April 2019 after the National Institute for Health and Care Excellence (NICE) declared that vaginal mesh should only be used as a “last resort”.

The scandal was quickly compared to the Thalidomide disaster of the 1960s. There was criticism of both the use of mesh in itself, and of the aggressive marketing tactics used by pharmaceutical companies to promote substandard products.

Less than a year on this criticism remains as relevant as ever.

Call for NHS to cease surgical mesh use where no evidence to support it

Professor Carl Heneghan, an expert in medical devices at the University of Oxford, has called on the NHS to stop using varieties of surgical mesh where there is no evidence in support of their clinical efficacy. He highlights that some categories of mesh have only previously been tested on animals for a short period of time - usually a matter of days. Tests of such a short duration are commonly undertaken to test for an immune system response. They do not provide an indication of pain or confirm the likely long-term effects.

The BBC reports that it has also seen a video produced by the company Ethicon Inc. Ethicon is one of the world’s largest manufacturers of surgical mesh. The video is believed to have been produced for viewing by members of the medical community only. In the video a surgeon performs a demonstration with one type of mesh and explains that it can become as “hard as stone” after only one year post-implantation. The most disturbing thing, however, is the fact that the video is now more than 10 years old and that the particular mesh used during the demonstration is still being implanted into patients by the NHS.

Current guidelines mean that new surgical mesh devices can be automatically approved for use if they are deemed similar enough to older products. There is, however, the very real risk that these “older products” were not adequately tested prior to their approval and so fall short of the standard expected of medical devices. By association, some newer devices will also fall short of the expected standard.

EU demands greater scrutiny

On a more positive note, EU regulations were approved last year which will re-classify surgical mesh as a “Class III” device. This means that it will be subject to greater scrutiny during the pre-approval process. The changes will come into force in the EU later this year and the government has provided assurances that they will be replicated in this country following the UK’s departure from the EU.

The fact remains that these latest revelations are an affront to the NHS’ guiding principles and “constitutional values”. They also add a new and worrying dimension to a scandal which has already ruined countless lives. It is unlikely that these latest findings will form the final instalment in the surgical mesh saga.

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Lucy Mellor is a Solicitor located in Manchesterin our Clinical Negligence department

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