Implanted mesh – The independent medicines and medical devices safety review

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7 min read

This Review was announced by the Secretary of State for Health & Social care in February 2018. The Review would examine how the healthcare system has responded (and make recommendations about how it might respond) to concerns raised about three medical interventions.

The three interventions identified for the Review were:

  • the hormone pregnancy test Primodos
  • the anti-epileptic drug sodium valproate
  • implanted surgical mesh

The Review was to have been published last week but has been delayed for an indefinite period given the focus of the country in dealing with the coronavirus.

The Review heard and collected evidence from a range of stakeholders. The Review website carries updates on the progress it has made, and hints at conclusions it may have reached. The use of mesh for stress urinary incontinence was paused shortly after the Review started and remains paused. The Review has already apparently concluded that harm caused by the use of mesh could have been avoided, and looks at the risks and balances to be understood surrounding the removal or partial removal of mesh, which many women have opted for to overcome ongoing symptoms they report.

The issue or context around the use of mesh, quite apart from whether it is inherently defective, (as to which see below) is one of competence in its use, including competency to understand how it might be used and the complications that might arise from its use, in order to ensure a woman choosing to have mesh implanted (or removed) can give consent. Earlier advice about using mesh, from the MHRA , was that whilst it was appropriate to be used (before its use was paused) it should only be used in the hands of surgeons competent to use it and secure effective consent for its use. In the Review website updates, specifically around the removal of mesh already implanted the commentary is that:

  • All mesh removal procedures must be conducted under a high vigilance regime
  • All decisions about a woman's suitability for a mesh removal procedure and the nature of that procedure must be taken by an appropriately trained and expert multi-disciplinary team
  • The operating surgeon must possess the necessary skills and competencies to carry out the procedure
  • The patient must be fully informed with the support of a patient decision aid
  • Consent must be recorded and be based on clear, unambiguous language
  • All explanted mesh should be measured and images taken of it
  • All removal procedures should be appropriately coded and entered onto a database
  • Outcomes must be monitored and recorded over an appropriate timeframe, including patient-reported outcomes. 

No doubt more will be said about this. No doubt NICE will refresh guidance and no doubt a national database about the use of mesh will be recommended.

Ongoing litigation – not quite group litigation?

Despite the postponement of the Review, the wheels of justice are still turning. On the 20 March 2020 judgment was handed down by Master Cook in the case of Paula Mackintosh (the Claimant) v Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield). The judgment comes from an adjourned costs and case management hearing (CCMC) which took place on 18 February 2020 and was a judgment given in the context of the Claimant’s lawyers suggesting that a large number of claims will emerge that raise similar issues and which may require co-ordinated case management, perhaps by way of a Group Litigation Order.

The Claimant’s claim against Sheffield is for compensation arising from alleged medical malpractice (or clinical negligence as the NHS refers to it) in failing to advise on material risks associated with the use of implantation of a transobturator or TOT tape. Master Cook is dealing with it as he is already dealing with product liability litigation arising from mesh implantation and it was anticipated there would be a large number of similar malpractice claims that would benefit from co-ordinated case management by a dedicated malpractice Masters.

The Claimant’s solicitors report they act for over 200 claimants - all of whom have received treatment for stress urinary incontinence or vaginal prolapse and who each has been treated by the insertion of a TVT (transvaginal tape), TOT (trans-obturator tape), or TVM (trans-vaginal mesh). In each of the claims the claimant alleges a breach of duty that, (a) the operative treatment was recommended without giving the claimant adequate advice on the risks associated with implantation of the mesh and (b) no or inadequate advice was given as to the alternative treatment options available. They report they are working closely with two other claimant firms (though there are more than three firms advertising on their websites for claimants to contact them about such claims) who are also acting for various size groups of claimants with similar claims. They say that at an early stage it had been recognised that unlike the product liability claims, where a defect in the implanted device was alleged, there was no true “common issue” in these claims which might make a Group Litigation Order appropriate, as the facts of each claim were unique though the breaches of duty alleged were similar. Some 42 cases had currently been identified as suitable for coordinated case management but of those proceedings had been issued in only five.  The Claimant’s lawyers urged the court to make an order requiring the Claimants to serve schedules of information in the five currently issued claims and then to list them for a joint case management conference.

For Sheffield, the NHS Resolution team pointed out that one of the features of litigation involving TVT, TOT and TVM was that large numbers of claims were threatened, and certainly lawyers acting for potential claimants were advertising their interest in assisting in the pursuit of such claims, but very few claims materialised. NHS Resolution were not opposed to case management proposals if there actually were large numbers of issued claims.

Master Cook thought the observations of the defendant were accurate and pointed to the “huge amount of publicity” surrounding the adverse complications alleged about the use of synthetic mesh to treat vaginal incontinence and vaginal prolapse. Certainly looking at the interim reports on the Review website it is clear that a vast amount of evidence has been provided from women reporting their experiences of pain and other injuries they relate to the use of tape and mesh.

The Master referred to two product liability cases progressing to trial in the High Court. Both are test cases brought against Johnson & Johnson, the JJML Stress Urinary Incontinence Products litigation QB-2017- 001720 and the JJML Pelvic Organ Products litigation QB-2015-008362. Whilst originally envisaged these claims might proceed under Group Litigation Orders, only a hand full of claims were issued and the large number of claims threatened, failed to materialise. Those two cases are progressing to trial. Master Cook noted a similar pattern emerging in the case against Sheffield in that the listing of the CCMC was delayed at the parties’ request on the basis there would be a large number of similar claims issued and served yet only five emerged.

Master Cook referred to directions made in the case of Talbot v Torbay and South Devon NHS Foundation Trust QB-2019-000604, which involved alleged negligent advice given to the claimant about an anterior repair procedure in September 2011 and a further procedure in March 2012, involving the insertion of an Uphold LITE Vaginal Support System manufactured by Boston Scientific. As the alleged breaches of duty occurred over eight years ago Master Cook saw no reason to delay the claim’s progress or to co-ordinate its management with the current Sheffield claim. He referred to the claimants’ solicitors having much work to do in terms of preparation and notification of the individual claims and that whilst some form of bespoke pre-action protocol might be agreed with the solicitors acting for NHS Resolution to further the overriding objective of CPR r.1.3 the feature of the case as presented did not justify delaying claims which are ready to proceed.

Clearly the publicity around mesh has resulted in considerable efforts made by claimant lawyers to invest in advertising their expertise in pursuing claims, based potentially on a defective product, or more likely (against the health providers) for inadequate advice. The Review is not primarily looking at apportioning blame for the use of mesh, but some will see that as a possibility. It may well be that come the publication of the Review there will then be a renewed interest in these claims, and certainly the directions given by the court in Sheffield will allow the court to reconsider case management again in the early part of next year. Of similar interest to insurers will be both the uniqueness of the circumstances when mesh or tale was used, and the impact of any large numbers of claims on aggregation or batching.

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