Data from private healthcare providers should be included in a new registry for pelvic mesh implants, the long-awaited report of the Independent Medicines and Medical Devices Safety Review said today.
The First Do No Harm report, based on the two-year review led by Baroness Julia Cumberlege, said it had been unable to identify how many women had been treated for stress urinary incontinence (SUI) and the repair of pelvic organ prolapse (POP) using polypropylene mesh because full data does not exist.
An experimental NHS retrospective audit of annual HES data on mesh implant procedures published in April 2018 has been widely criticised for underestimating long-term complications from the procedures and its failure to include any data from private sector providers.
Pelvic meshes used in the treatment of SUI and POP have resulted in highly variable outcomes, causing a range of life changing conditions, including chronic pain, infection and permanent nerve and organ damage, in some women.
However, the report said the healthcare system did not know how many women had been successfully treated and what proportion of them had been left with permanent physical and/or psychiatric injury.
NHS Digital is due to start collecting mesh data towards the end of this year and the report is urging the database to be broadened to include every relevant surgical procedure for the treatment of SUI or POP. It also wants to see the datasets feed into national registries for pelvic mesh and new medical devices that can be interrogated over time to assure long-term efficiency and to detect harm.
The wide-ranging review examined the use of three treatments: pelvic mesh implants, hormone pregnancy tests which have been associated with birth defects and miscarriages, and sodium valproate – an antiepileptic drug which can cause malformations and developmental delay in children when taken by their mothers during pregnancy.
In echoes of the Paterson Inquiry Report, it tells of a disjointed system where patients struggle to be heard and are unsure where to direct their complaints and where clinicians and organisations are not held to account.
‘We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago,’ said the report.
In total, the report makes nine recommendations including the appointment of a patient safety commissioner and the establishment of a network of specialist centres to provide comprehensive treatment for patients affected by implanted mesh. It also urged the government to immediately set up a task force to implement its recommendations.
Review chair Baroness Cumberlege said: ‘The first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases concerning Primodos, sodium valproate and pelvic mesh, our system has failed in its responsibilities. We met with people, more often than not women, whose worlds have been turned upside down, their whole lives, and often their children’s lives, shaped by the pain, anguish and guilt they feel as the result of Primodos, sodium valproate or pelvic mesh. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better.’
Responding to the report, Dr Howard Freeman, clinical director of the Independent Healthcare Providers Network, said: ‘At a time of rapid growth of implantable medical devices both in the UK and internationally, it’s vital that we have a more joined up approach to recording and regulating the use of medical devices across the whole healthcare system to keep patients safe.
‘The independent sector is committed to putting patients at the heart of what we do and continuously improving the care they provide to patients. We therefore welcome Baroness Cumberlege’s review which makes a number of important recommendations to ensure any concerns around medicines and medical devices can be identified and acted upon as quickly and effectively as possible, with greater coordination across the health system to ensure all patients can access the safest possible care.’