On Tuesday 28 March 2017 the Scottish Independent Review (IR) of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women was published. Commissioned to review concerns around complications following the use of such products, and relying on an appointed “Expert Group” the IR has not recommended that the use of such products should be suspended, which is what those petitioning for the setting up of the IR wanted (among other things). That means that the position on using such products remains as set out in guidance from the Medicines and Healthcare products Regulatory Authority (MHRA) in 2014 , which is that the benefits of the use of vaginal mesh implants outweigh the risks. In 2014 the MHRA considered there was “no justification for taking any regulatory action to remove these devices from use in UK hospitals”. Although there was a call for use of them to be suspended in Scotland, their use has continued in appropriate cases and where patients consent.
Governance and training
The conclusions of the IR focus instead on the need for improved governance around the introduction of new procedures/techniques (including the training and revalidation of clinicians involved in the giving of advice and the surgical procedures attending the use of these products) and how adverse events are reported and acted upon. Although focussed on the NHS the context of the IR recommendations have a broader application to the independent healthcare sector, where only limited data is available.
The Scottish Litigation
With litigation ongoing in Scotland this IR has a number of detractors, as the media have reported since the report was published. The legal claims are for damages for personal injury arising from a) the alleged mis-use or b) the alleged failure (in product safety terms), of specific mesh products and c) the alleged lack of appropriate information regarding possible complications following the use of such products. The focus of such litigation is twofold. First, in relation to the cases against the Health Boards, the claim is that there was a failure by clinicians to obtain patients informed consent (by fully discussing and disclosing material risks and alternatives). Outside the NHS similar “consent” type arguments are raised against private providers and surgeons.
In relation to the case against the manufacturers, the claimants (“pursuers” in Scotland) are seeking to establish that the manufacturers were negligent at common law by offering products which were inadequately tested and in allegedly misrepresenting failure and complication rates. There is also an argument against the manufacturers under the Consumer Protection Act 1987, which requires a claimant to establish that a defective product has been manufactured.
The IR reported that as at February 2017 there were 426 claims in relation to the use of vaginal implants in women with SUI and POP involving NHS treatment. There are additional claims involving private treatment, but figures are not published. Of these claims, 390 court actions have been issued with the court directing defences to be lodged by 22 September 2016 in a group of cases from which a group of lead cases will be identified with the other cases stayed pending the outcome of the lead cases.
It is worthwhile looking at what is happening across the pond. Data from the US Judicial Panel of Multidistrict Litigation from July 2015 (referred to in the IR) revealed that the number of US lawsuits in relation to the use of vaginal implants in women with SUI and POP is estimated at 100,000. These cases only involve the manufacturer rather than the health care provider or doctor. So far, 18 trials (relating to 24 patients) have reached a verdict or settlement during trial. 11 of the cases related to POP procedures, ten of which related to vaginal mesh implants and one where the POP procedure was combined with an SUI mesh tape. In this combined case and in four of the solely POP procedures, a jury reached a verdict in favour of claimants. No jury verdicts were in favour of the manufacturer. In the remaining six cases, the manufacturer reached a settlement during the trial.
For SUI procedures, one case related to retropubic mesh tape. The case did not reach trial with the judge directing the case should be found in favour of the manufacturer before the trial started. Six cases related to transobturator mesh tapes. Jury verdicts in favour of the claimants were found for five cases and, in a single case, in favour of the manufacturer. One manufacturer settled thousands of claims in an out of court settlement without accepting any liability. It should be noted that the legal test against which these cases were judged is not that set out in the Consumer Protection Act (1987) applicable in Scotland.
Adverse Incident Reporting
The IR also looked at the issue of adverse incident reporting, or rather under reporting and noted the guidance of the British Society of Urogynaecology (BSUG) which lists adverse events from the use of synthetic meshes for prolapse and incontinence and includes:
- Vaginal exposure
- Erosion into the urinary tract
- Erosion into the bowel or rectum
- Mesh shrinkage
- Organ perforation
- Nerve or vascular injury
- Sexual difficulty
Although manufacturers have a statutory duty to conduct post market surveillance, and although clinicians and patients using the devices provide individual feedback, reporting of adverse events is not universal and this diminishes the function of adverse event reporting which is the early detection of new, rare or serious problems with a device.
In their conclusions, the IR (not surprisingly) restated that no surgical intervention is without risk. While for some women the complications arising were life changing and irreversible, for the majority serious complications did not occur. The following (summary) conclusions/recommendations, drawn from the evidence the IR collected, are:
- Fundamental to the treatment of patients is patient-centred care including shared decision making supported by robust clinical governance. The Scottish Government should consider the alternative methods for the capture of adverse events to determine the most effective way to ensure complete notification.
- Evidence of local and national audit activity and the mandatory recording and reporting of adverse events, should be in line with GMC guidance and a necessary part of consultant appraisal and the revalidation of clinical staff.
- Consent to treatment processes should be tested and developed for effectiveness. This should be addressed by the Expert Group as a matter of urgency.
- Coding and data capture processes should be refined to allow more precise recording of mesh surgery and any subsequent mesh removal/revision within routine NHS activity data records.
- The Expert Group should review the training and information available to clinical teams.
- Transvaginal mesh procedures must not be offered routinely but in line with developed treatment pathways.
The Scottish Government has said it had accepted the recommendations in full.
Some might be forgiven for thinking that little has emerged from this review that has not been covered in other earlier reviews, beyond a call for better adverse incident reporting and the use made of such reports. In December 2015 for example the NHS England Mesh Working Group reported that MHRA’s investigations with mesh manufacturers, professional clinical organisations and Notified Bodies, and reviews of published research literature had not found evidence to show that the POP and SUI mesh did not comply with the Regulations. Such evidence would be necessary to justify taking enforcement action against manufacturers such as suspending or removing their devices from the market. Regular consultation with other European and worldwide regulatory authorities has provided similar views.
The MHRA identified in 2014 the need for the appropriate use of such products, by clinical staff familiar with their use so that informed consent was provided.
To the extent that anyone hoped this report would support the litigation already afoot in Scotland, it does not.