A mesh ‘audit’ is meaningless unless we have reliable data and hear from those who have been harmed - a blog by Kath Sansom

Summary

In this opinion piece, Kath Sansom, founder of Sling the Mesh, looks at why an audit of pelvic mesh outcomes due to be published in April 2023 has again failed to capture the true extent of the harm caused by the procedure. She outlines why the approach taken by the Government and NHS Digital was flawed and why it is so important to understand both the proportion of women who have experienced harm as a result of the procedure, and the nature of their injuries and side effects.

Content

The definition of ‘success’ for incontinence mesh surgery was based on The British Society of Urogynaecology (BSUG) ‘pad test question’, which looked at whether a woman was using fewer incontinence pads after surgery. Like most women who had a mesh sling for incontinence implanted, I passed this test with flying colours. But the complications I experienced as a result of the surgery were painful, debilitating and life-changing, an experience shared by thousands of women who have had a pelvic mesh implant.

For both incontinence and prolapse mesh, outcome logging merely looked at whether the prolapse had been fixed and did not query the onset of new pain or complications. Lack of follow-up, data collection and recognition of mesh as the cause of women's symptoms when they present with complications has led to a gross underestimation of the scale of pelvic mesh-related harm. So the prospect of an audit that would look to remedy this was a positive one.

In 2020, the final report of the Independent Medicines and Medical Devices Safety (IMMDS) Review, ‘First Do No Harm’, called for “a retrospective audit and follow-up of women who had pelvic mesh surgery in 2010,” to be conducted by NHS Digital. The report highlighted that this should provide “far greater detail on mesh complications in the decade after surgery,” and that NHS Digital should make “every effort” to obtain sufficient data.[1] 

On 5 December 2022, the Minister for Women, Maria Caulfield MP, confirmed in the Commons that an audit had been completed following the acceptance of the IMMDS Review’s recommendation and would be published in 2023.[2] However, the record later had to be corrected, as it became clear in a further parliamentary question that, contrary to the stated intention of NHS Digital who conducted the audit, “...only Hospital Episode Statistic data was used in the audit and no other data was employed. Patients were not contacted as part of this audit.”[3]

History repeats itself - the NHS audits the same data

I was horrified to find out that instead of making “every effort” to get accurate information, NHS Digital have simply repeated the same exercise they carried out in 2018 in their retrospective audit of annual Hospital Episode Statistics (HES) data on mesh implant procedures. For the 2023 audit, they used the same approach taken in the 2018 audit and exclusively used HES data. This approach was highlighted in ‘First Do No Harm’ as being “widely criticised for its omissions, [for example] lack of any private sector data and for its implied underestimate of long-term complications.”[1]

I wrote to the Health and Social Care Select Committee on behalf of Sling the Mesh in December 2022 to highlight the shortcomings of using HES data in isolation.[4] The Committee shared our concerns, highlighting that:

“Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”... Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to proactively contact those who have had the procedure about their postoperative experiences and possible side effects.”[2]

NHS Digital’s approach does not paint a true picture of the extent of the harm caused by pelvic mesh. There are many issues with using purely HES data for a mesh audit, namely that:

• HES data does not capture complications, as women have not been followed up and therefore the spectrum of suffering has not been logged.
• it does not take into account any data from GPs or primary care, where potentially thousands of women have sought help for their mesh complications. Most of these women will not yet have set foot in a hospital for consultation or treatment.
• it does not take into account data from private hospitals, which may be recorded differently or not have been logged at all.
• there are discrepancies in how pelvic mesh insertion and removal is logged by different trusts and healthcare professionals.
• HES data sometimes lacks necessary detail on the nature of treatment. For example, until recently, there was no specific HES code for rectopexy mesh insertion or removal, which means the specific issues associated with this surgery are difficult to identify through data.

How should the Government conduct an audit of mesh patients?

If the Government is serious about understanding the true extent of harm caused by pelvic mesh, it needs to contact all women who have had mesh surgery within a specific time period to establish whether they have had complications or injuries over the following years. Mesh has a ticking time bomb nature, in that it can be fine for many months or even years before causing problems like erosion, so this long term follow-up is crucial to gauge the extent of harm. Instead of using unreliable and incomplete data, an audit needs to take the approach of the Paterson Inquiry and recall all affected patients.[5] If the cost of such an exercise would be prohibitively high, they could take a sample of women from across the country and use their findings to estimate the extent and nature of harm caused by pelvic mesh.

Why is a reliable pelvic mesh audit important?

Being able to quantify the extent of the harm is important so that we can establish an accurate figure of risk; what percentage of women suffer harm due to pelvic mesh, and what is the likelihood of more of them developing complications in years to come? Until we have this knowledge, the Government and regulatory system can’t learn the necessary lessons from the mesh scandal to ensure other devices don’t cause this degree of harm. 

Health services will also continue failing women when they seek help for injuries and complications that are likely to have been caused by mesh. So many women have also been subject to the secondary harm of gaslighting and not having their symptoms taken seriously by healthcare professionals. Having accurate data on harm caused by mesh would help put an end to the healthcare system seeing women’s concerns as ‘hysterical hearsay’. It would also help women understand that their complications must be taken seriously and that their symptoms are not ‘all in their heads’.

Why is the Government not pushing for an accurate audit?

When compared to the Government response to Paterson, the retrospective mesh audit seems like a token effort. Why is the Government less willing to understand and tackle the issues associated with mesh complications? Perhaps because, rather than being the responsibility of “one bad apple”, the harm caused by pelvic mesh is the responsibility of a system that failed to research, regulate and monitor the effects of medical devices designed to be implanted inside people’s bodies.

There is also the fact that knowing the true extent of the harm caused by pelvic mesh has the potential to create a huge financial burden, if the Government ever agrees to fulfil its responsibility to set up a Redress Agency for women harmed by pelvic mesh surgery.

Related reading

The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims (17 January 2023)
Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog (19 July 2022)
“There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery (1 May 2022)

References

1 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020
2 Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response Sixth report of session, 20 January 2023
3 Question on surgical mesh implants. Parallel Parliament, 14 December 2022
4 Letter to Health Select Committee December 2022. Sling the Mesh, December 2022
5 Government response to the independent inquiry report into the issues raised by former surgeon Ian Paterson. Department of Health and Social Care, 16 December 2021