Concerns about the use of synthetic mesh to repair pelvic organ prolapse (POP) and stress incontinence, conditions commonly associated with childbirth, have been circulating for years.
Indeed, in 2009 NICE called into question some elements of the procedure although it stopped short of an outright ban. In Scotland, use of the mesh was suspended in 2014 pending a safety investigation but it was only in 2018 that the Health Secretary, Jeremy Hunt, ordered a review into the use of the mesh following reports of the harm that some women had suffered as a result of the surgery. The review panel reported its findings on 8 July 2020.
Much of the suffering was avoidable
The Independent Medicines and Medical Devices Safety Review (IMMDS) led by Baroness Cumberlege was also asked to examine the effects of two pharmaceuticals: Primodos, a hormonal pregnancy test (in use until 1978), and epilepsy drug, sodium valproate, both of which have been linked to birth defects. The review was designed to cover fresh ground: how quickly and thoroughly the authorities had responded to complaints; whether regulators engaged sufficiently with those affected to ensure their complaints were acted on; and whether any of the cases merit an independent inquiry. The report makes for shocking reading – most of the people who had suffered as a result of either taking the two drugs or after having a mesh implant were women and it has taken years for their voices to be heard. Baroness Cumberlege, having acknowledged the tremendous work carried out by healthcare professionals coping with the Covid-19 crisis, noted that “much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself”.
Regulators failed to respond to concerns
The manufacturers of both drugs have repeatedly and strenuously denied any link between taking the drugs and birth defects, a position supported by a group of experts who concluded in 2017 that Primodos was not the cause of birth deformities. This conclusion condemned as a whitewash by Yasmin Qureshi, Labour MP for Bolton South East who has been campaigning on behalf of those affected. The purpose of the IMMDS review was to examine the way in which the health authorities and regulators responded to the complaints of those affected, some of whom had been campaigning for decades to have their voices heard. As Jeremy Hunt pointed out when announcing the review in February 2018 “It is an essential principle of patient safety that the regulatory environment gives sufficient voice to legitimate concerns reported by patients, families and campaigners…”.
Review reveals systemic failure
The review was asked ‘to consider how to strengthen the patient voice’ by looking at ‘how the healthcare system reacted as a whole’. Although the panel was asked to consider other medical devices, medicines and interventions also believed to have caused harm, its remit remained restricted to the mesh and two drugs. Nonetheless all those concerned about the safety of drugs or devices should derive some comfort from the report’s findings, concentrating as it has on the systemic failure of health and regulatory bodies to take complaints seriously. The review took two years and, although it focused on England, interviews with those affected were held from all over the UK, many of which were described as ‘harrowing’.
The predominant theme that emerged from the review was the lack of long-term monitoring of the effects of new treatments, drugs and devices and a dismissive, arrogant attitude from clinicians when concerns were raised. Patients also reported a lack of information, preventing them from making an informed decision about the proposed treatment; many told the review group that they were not told of side effects or that their complaints were labelled as ‘normal’ or simply as a result of being menopausal. As pernicious, the review identified a culture of denial, an absence of effective accountability, resistance to no-blame learning, and a failure to implement patient safety policies.
Patient Safety Commissioner
As I have mentioned in the past, patient safety should be paramount which was the principle behind the ‘Sign up to Safety’ initiative launched in 2014 encouraging hospitals and clinicians to ‘reduce avoidable harm’. As this damning report has revealed, patient safety, for many, appears to be a relative concept leading the review panel to recommend the appointment of a Patient Safety Commissioner with statutory responsibility. Other recommendations designed to address the systemic failure responsible for so much hurt and pain is the creation of a Redress Agency to resolve patient complaints more quickly by becoming a central repository for adverse event reports, and an overhaul of the Medicines and Healthcare Regulatory Authority. The panel also recommended specific action to support those who have been directly affected by the pelvic mesh and the two drugs.
Hospital policies and procedures exist for a reason.
If manufacturers of precision components were allowed to supply their customers with products that had not undergone rigorous testing and follow-up there would be an outcry. Somehow the manufacturers of medical devices and pharmaceutical companies have been able to supply products, that have not been adequately tested, to clinicians who have used them without proper regulatory oversight to the detriment of the patients they are treating. This report has shed light on a number of very dark corners in the health system but only time will tell if it helps to cure the fundamental problems at the root of this systemic failure.