In a recent article we discussed the findings of the Scottish Independent Review of the use of transvaginal mesh implants to resolve stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The Independent Review report was published on 28 March 2017, and developments around this subject have continued in the time since. In addition headlines such as the BBC - “hundreds sue NHS over “barbaric” treatment” – continue to put the use of the product and developing litigation around its use in the spotlight.
Developments in Guidance and Regulation
The Mesh Oversight Group (the “Group”) was set up to identify the key issues with mesh implants and make proposals for the way forward. Following their interim report in December 2015, the Group published its final report on 25 July 2017, setting out what actions had been taken to fulfil their recommendations.
The three key concerns with the use of mesh devices identified by the Group were:
- The quality and amount of data available on the procedures.
- The consent process.
- The clinical quality of care received.
The Group recognised that there was there was insufficient data to provide a full picture of the complications arising from mesh surgery, and therefore recommended that the use of established reporting methods be promoted and more detailed data should be captured.
The Group reported that:
- The MHRA continues to promote the use of its Yellow Card Scheme and analysis on whether use of this system has increased will be forthcoming
- NHS improvement have contacted the relevant Responsible Officer to ensure the trust appraisal systems are used effectively
- The British Society of Urogynaecology (BSUG), the British Association of Urological Surgeons (BAUS) and the Royal College of Obstetricians and Gynaecologists (RCOG) have reiterated the importance of reporting to their membership
In accordance with a recommendation to increase the quality of data captured, specific HES OPCS codes have been established to classify full or partial removal of vaginal mesh for POP. Further, a subgroup has been formed to carry out a cost/benefit analysis of setting up a central registry for SUI and POP procedures.
It was recognised by the Group that in order to give informed consent the patient must understand the procedure and its risks. Learning resources have been prepared and disseminated to improve GP and patient awareness of the treatment options for SUI and POP. These have been shared between the practices and commissioners and are available on the BSUG, BAUS, and RCOG websites.
In order to improve certainty in the consent given by patients, the patient information leaflets now contain a page for the patient and clinician to sign indicating that the patient has (1) read the leaflet and understood its contents, and (2) has discussed the risk of the procedures with their surgeon. This is not a consent form but does encourage the patient to consider their level of understanding before undergoing treatment.
Quality of Care
The Group’s recommendation for the establishment of a nurse helpline service for mesh-injured women was not implemented, as the number of calls the Scottish pilot scheme received was too low to make the initiative cost effective. Instead, 18 hospital trusts have identified themselves as having the requisite multidisciplinary teams to enable them to provide treatment for women with mesh complications. NHS England’s Complex Gynaecology Specialist Commissioning Team will consider whether to commission named centres for this treatment.
Following the Group’s consultation, updated NICE clinical guidelines for the management of SUI and POP will be published in early 2019. In the meantime, NICE have updated a large number of Interventional Procedure Guidance for mesh procedures, with a few more expected in the coming months. Further, new guidance on the use of Transvaginal mesh in the repair of anterior or posterior vaginal wall prolapse has just been published on the NICE website (you can view it here). This guidance recommends that mesh used to resolve POP should only be used in the context of research, but it does not affect the use of mesh for SUI.
Concerns have also recently been raised about the way in which mesh implants have been regulated.
A recent study suggests that around 61 types of surgical mesh used in POP procedures in the USA appear to have been approved for use on the grounds that they are “equivalent” to one of two mesh implants that obtained full approval before the FDA reclassified the devices to Class III (requiring pre-market approval). The two original mesh implants obtained their approval in 1985 and 1996 respectively which means that the majority of implants have been approved on the basis of evidence that is potentially out-of-date.
In the UK, this contentious topic reached debate in the House of Commons on 10 October 2017, in which it was noted there is currently not enough evidence to ask MHRA to reclassify the procedure as “high risk”.
The EU regulation currently controlling these medical devices is set to be replaced by a new regulation which will come into force in 2020, and it is anticipated that it will reclassify mesh implants intended for long-term or permanent use from a Class IIb device (medium to high risk) to a Class III device (high risk). At the time of writing it is unclear how or whether future regulations will be transposed into UK law following Brexit. The Health Committee is currently conducting an inquiry into the options for the UK government and are considering submissions from a number of respondents, including “Sling the Mesh”, a large national campaigner against the use of transvaginal mesh.
Developments in Litigation
Litigation arising out of the complications associated with mesh implants is ongoing around the world.
In 2016, four pelvic mesh cases against various parties local health trusts, a medical practitioner, and an Insurer were remitted to the Scottish Court of Session on the grounds they were going to be of “significant public interest”. The court found that the defendant’s reliance on the fact that these mesh implants were licenced for use in the UK meant that “resolution of some of the cases may require development in areas of law for which there is no authority”. More recently, on the 19 October 2017, the High Court allowed a claimant to bring her claim of professional negligence against her surgeon, despite the fact her claim was outside of the limitation period.
It is reported that over 800 women have brought cases in the UK, around 426 of which are in the Scottish Court of Session, and at the end of July 2015 over 100,000 claims had been made against the mesh manufacturers in America.
On the other side of the globe in Australia, mesh products were compared with Thalidomide, and a large class action against Johnson & Johnson on behalf of “thousands of women” opened on 4 July of this year. Their case may be strengthened by the recent removal of POP mesh products from the register of the Australian Therapeutic Goods Administration on the grounds the potential benefits to women do not outweigh the risks.
The majority of medical bodies appear slow to rule out the use of mesh to resolve SUI and POP, instead choosing to focus on improving the quality of the consent given by patients. Development in this area will continue as the consequences of Brexit on the regulation of medical devices unfold.
Within the last few months a number of significant medical and political bodies have put forward their conclusions on the use of mesh implants. Whilst transvaginal mesh remains a contentious issue, the anticipated guidance and developments in regulation may offer some clarity in the future, while the noise from the lobby supporting litigation and redress for past use increases in volume.