Groups formed by patients grievously and sometimes permanently harmed by medicines and medical devices — such as valproate-damaged babies, and women with complications of vaginal mesh and breast implants — have found a shocking lack of transparency over adverse effect data, and such low standards for device approval that serious risks to patients are inevitable. When the Independent Medicines & Medical Devices Safety Review (the “Cumberlege Report”) is finally published, HealthWatch is hoping to see action on 5 demands that will show patients are being put before profit.
The Review, chaired by Baroness Julia Cumberlege, aims to examine how the healthcare system has responded to concerns raised by patients and families about three medical interventions: the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate, and vaginal mesh. It was due to be published today, 24th March 2020, but is now delayed indefinitely as a result of COVID-19.
Surgical mesh products are among over 500,000 different medical devices and in-vitro diagnostic devices on the market in the UK, produced by over 3,500 companies turning over around £22bn, employing 120,000 people and accounting for £5bn in exports annually. “Yet there is currently no comprehensive list of devices on the market, no way of identifying and tracking them, and no clear idea of how many patients are harmed,” says Dr Susan Bewley, HealthWatch’s chair. “The government is keen to protect business, but this should not come at the expense of patient safety.” HealthWatch has also supported efforts to get more transparency into the system because commercial secrecy can harm (or even kill) people. “Patients are entitled to know who’s paying their doctors and scientists when innovations are rushed to market without safe post-marketing monitoring systems”.
In November 2019 HealthWatch wrote a letter to Baroness Cumberlege to ask the Independent Medicines & Medical Devices Safety Review to demand that those who implant a device must know (and be able to explain to the patient):
- what it is and what its constituents are
- how it is identified and tracked
- how the evidence shows that it works
- what risks are involved
- what to do if things go wrong.
In response, the Review team is to publish our letter and evidence on their website when the Review is published.
In June 2019 HealthWatch convened a medical symposium in central London: Evidence, Healthcare and Medical Devices & Implants which brought together scientists, patients, manufacturers and regulators to clarify the current issues facing evidence based healthcare in the field of medical devices and implants. Our 5 demands appear in a HealthWatch Strategy document resulting from those discussions.
There is more about our work on Medical Devices on the HealthWatch website here.
The Independent Medicines & Medical Devices Safety Review was announced in the House of Commons in February 2018 by Jeremy Hunt MP, the then Secretary of State for Health and Social Care, and was due to be published at 11:30am on 24 March 2020, see the IMMDS Review website.