This week, it has been announced that NHS England and the Department of Health and Social Care have accepted the recommendation of The Independent Medicines and Medical Devices Safety Review to suspend the use of mesh slings for the treatment of stress urinary incontinence (SUI). This suspension takes immediate effect and comes after years of campaigning by women affected by gynaecological and urological mesh implant procedures. It also follows guidance by NICE in December 2017 which recommended that transvaginal mesh implants for prolapse should only be used in the context of clinical research.
A common feature in the reporting of this significant development has been to highlight the differences in approach which have been adopted by the Governments across the UK in response to the controversy surrounding the use of mesh implants in the treatment of SUI and pelvic organ prolapse (POP). As a devolved matter, issues of healthcare are dealt with by the separate administrations rather than centrally, and the speed and form of the responses has varied greatly. Scotland has been commended as the front runner in recognising the problems associated with the mesh procedures and reacting to these but, in reality, is now falling behind.
Four years ago, it seemed that the Scottish Government was leading the way in giving recognition to those injured by mesh devices and in preventing more women from undergoing the same procedures. In June 2014, a Scottish Independent Review was announced and the Acting Chief Medical Officer, Dr Aileen Keel, wrote to all health boards to suggest that they consider suspending the use of synthetic mesh implants in the treatment of SUI and POP. This voluntary moratorium on the use of mesh devices was of course a victory for the Scottish campaigners and did lead to a reduction in the number of procedures carried out. However, it did not prevent the use of mesh implants as first line treatments for incontinence or prolapse. A number of health boards continued to carry out these operations and are still able to do so today.
The recent suspension in England has the potential to have more force as it seems that the level of discretion afforded to Health Boards in Scotland is not being given to the individual NHS Trusts. The suspension is not a complete ban on the use of mesh products, and is in fact restricted to the incontinence procedures only, whereas the 2014 recommendation in Scotland applied to procedures for prolapse repairs as well. However, it still has the potential to offer greater safeguards while the review of the devices continues than the apparently comparative measures previously taken in Scotland.
The Independent Review into the use of transvaginal mesh implants in Scotland was completed in March 2017. It had been hoped that its conclusions would result in more protection being offered to women than the 2014 call for health boards to stop these procedures. The recommendations did highlight a number of concerns in the practices surrounding mesh procedures but it fell short of recommending a ban on the use of synthetic mesh in SUI or POP operations. Further, the review has been widely criticised by campaigners, and a clinician who resigned from the review, for a failure to address key concerns and evidence.
At present, the impression from the review underway in England is that the experiences of women who have suffered often debilitating and life changing injuries are being taken seriously by Baroness Cumberlege and her team. There remains a possibility that the tape procedures which are used to treat stress incontinence will be reintroduced if certain criteria are satisfied but for the time being the accounts of those who have been affected by the devices first hand are being heard. Against the culture of disbelief which many women have faced this can only be a positive step.
Following the announcement of the position in England, the Chief Medical Officer in Northern Ireland has indicated that he will be writing to the trusts to advise that a similar halt on procedures be introduced.
Where does this leave Scotland in comparison to our neighbours?
As yet, there has been no indication of whether the Scottish Government is considering introducing a more forceful suspension or ban on the use of these devices. In light of the criticisms levelled against the Scottish review which was published last year, its processes are being considered by Professor Alison Britton. However, the outcomes and recommendations will not be changed as a result of this.
Evidence regarding the complications associated with mesh devices continues to emerge and looking further afield to Australia, where the litigation and reviews of the devices are more advanced, transvaginal mesh products for the repair of POP have been removed from the market and the regulation of devices for the treatment of incontinence has tightened. In New Zealand the ban extends even further to cover both POP and SUI devices. From its once leading example, the Scottish response now appears lacking when compared with elsewhere and more needs to be done to ensure those seeking treatment are not exposed unnecessarily to the well-known risks associated with these synthetic mesh products.
Blog by Amy Haughton, Solicitor