Wed, 11 Apr 2018
The litigation of vaginal mesh is becoming more and more widespread. This may be as a result of increasing awareness of the complications that can arise post mesh which is borne out by the media storm in the past year, along with the high-profile presence of anti-mesh campaigners such as Sling the Mesh. Despite this, there are no reported authorities nor legal articles that I can find on the subject. This article seeks to provide a summary into the background and litigation of these cases.
What is vaginal mesh and what is it used for?
Vaginal mesh or tape is a woven sheet of polypropylene (a synthetic material) that can be permanently implanted to repair damaged or weak tissue. Historically, mesh was first used for hernia repair in the 1950s and it was licensed for vaginal use in and around the 1970s. Mesh can be used to treat both stress urinary incontinence (SUI) and pelvic organ prolapse (POP). SUI is a condition where there is involuntary leaking of urine from the urethra following exertion or effort, which occurs as a result of weakened pelvic floor muscles. POP occurs when the pelvic floor muscles of any of the pelvic organs (uterus, vagina, bladder or bowel) are weakened causing the organ to bulge (prolapse) into the vagina. Such prolapses can affect urinary, bowel or sexual function.
Treatment and complications of mesh
There are a number of conservative and surgical non-mesh treatment options for both SUI and POP and the national guidance (including National Institute of Health and Clinical Excellence (NICE) guidance and the Royal College guidance) has generally advocated that conservative options should be used as a first line of treatment. Treatment options include pelvic floor exercises, colposuspension (placing of sutures to elevate the vagina and support the urethra) and colporrhaphy (surgical repair of vaginal wall). Such treatments can lead to varying outcomes, many improving the patient’s quality of life, however on occasion a very small proportion can result in continuing or deteriorating symptoms, leading to a need to consider other treatment options.
In cases of SUI, a tension-free vaginal tape (TVT) or a trans-obturator tape (TOT) can be inserted to fit under the urethra like a hammock or sling to support it and prevent leakage. In cases of POP, the mesh is inserted on the site of the prolapse to support it and prevent the organ bulging into the vagina. Unfortunately, there are a number of risks associated with mesh. The complications that can arise include mesh erosion where the mesh becomes embedded into the tissues and cannot be removed, pain syndromes including neuropathic pain and abdominal/vaginal pain, infections, bleeding and damage to nearby organs. Such injuries can lead to functional problems with mobility and sexual intercourse as well as inevitable psychiatric injury. Patients can elect to have mesh release surgery however this is not successful on every occasion due to the mesh eroding and becoming embedded into the tissues. In short, mesh use can result in the full spectrum of injuries which can range from minor symptoms of discomfort to permanent debilitating conditions. Stories in the broadsheets recently have highlighted the death of a Canadian lady from sepsis due to mesh, women who are permanently wheelchair-bound and others with apeurenia and relationship breakdowns.
In December 2017, NICE released some interventional procedures of mesh for POP to level 3, which is for research purposes only, meaning that it should for the time being not be used to treat POP. Mesh can still however be used to treat SUI and indeed fewer complications arise.
Litigating mesh claims
Mesh claims can be pursued under common law as clinical negligence claims or under the Consumer Protection Act 1987 (CPA) as product liability claims. I do not know of any mesh product liability claims in the UK that have settled or been won at trial to date. Indeed, if there are any such claims that have succeeded against the manufacturer, they are very few indeed.
This is a different picture to that in other jurisdictions, such as the US where actions against the manufacturers have been litigated and either settled out of court or won at trial. Furthermore, in Australia, there is a large class action against the manufacturer with judgment due soon and in Scotland, there are actions against both the health boards and the manufacturer.
When deciding how to litigate mesh cases, practitioners have a duty to explore both product liability and clinical negligence and indeed defendants may wish to consider bringing in another Part 20 defendant.
Clinical negligence claims
The two main areas of clinical negligence are first, a failure to obtain informed consent and secondly, substandard surgical placement of the mesh or tape. Other possible areas of negligence include failure to identify organ damage intra-operatively or a delay in treating post-mesh symptoms. Of course, the facts should be evaluated like in any other clinical negligence case and experts will need to consider all aspects of negligence.
In respect of consent, the Supreme Court authority of Montgomery v Lanarkshire Health Board [2015] remains the ‘go-to’ case and applies retrospectively. It set down a new duty for doctors, departing from the usual Bolam standard of care applied in clinical negligence cases. For sake of completeness the test is as set out below (emphasis added):
The doctor is… under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor was or should reasonably be aware that the particular patient would be likely to attach significance to it.
When considering whether the doctor has obtained informed consent, it is important to consider what knowledge/standard/guidance was in place at the time of the index events, in order to understand what a responsible body of uro-gynaecologists would have known at the time to advise a patient. For example, the guidance and literature may say in 2010 that there was a 3% chance of mesh erosion when used to treat POP. A reasonable person would likely attach significance to the risk and therefore the doctor would have been under a duty to ensure the patient was aware of this before obtaining informed consent. If the patient was not made aware of all the risks which will be a matter of fact (evidenced in the medical records, consent form and the witness evidence), this would amount to a breach of duty.
The second limb in Montgomery is that, if advised appropriately, would the patient have provided informed consent? Practitioners will need to consider carefully, given the discrete facts of the case and the claimant’s evidence/history and content of the medical records, whether on balance she would have agreed to have the mesh surgery or not. Given the intrusive and chronic nature of SUI and POP symptoms, many patients may well elect to have mesh surgery notwithstanding the risks or availability of potentially less efficacious options available to them. Indeed, if a patient has had the symptoms for a long period of time with little improvement from other treatment options, the defendant may well have a reasonable argument to challenge the assertion that the provision of appropriate information to the patient would have made any difference to the outcome at all.
In respect of substandard surgical placement, the technique for mesh implantation varies widely between abdominal incision or vaginal approach. Different approaches present different risks; for example, TOTs bring a greater risk of chronic pain than TVTs due to nerve proximity whereas TVTs attract a higher risk of bowel/bladder damage. It can be challenging for claimants to satisfy a court on balance that there is substandard placement as the mesh may have migrated or become eroded into the tissues which could explain a condition or injury.
In my experience, mesh cases have settled on consent and defendant trusts seem to be live to the problems that can arise when a surgeon does not advise of all the risks and benefits of mesh implantation and other reasonable treatment options. That said, surgeons/clinicians may not be aware of all the risks associated with mesh due to no fault of their own but rather as a result of an omission in the instructions for use/training received and other information received from the manufacturer. Consequently a failure to advise by the surgeon may actually be as a result of a product liability and not clinical negligence.
Product liability
Product liability claims can be challenging to run as they are aggressively fought and it can be difficult and slow to get responses and disclosure.
Under the CPA, the claimant has to establish three things in a product liability claim:
- that the defendant manufactured the product;
- that the product was defective within the meaning of s3(1) CPA. The Scottish government’s report on transvaginal mesh implants (www.legalease.co.uk/meshimplants) defines this section as stating that a defective product is:
… one in which the safety of the product does not meet the standard which consumers are entitled to expect. This can include the safety of materials and components within the product, any instructions and/or warnings needed in using the product, and what the expected use of the product might be…
And
- that the defect caused the injury.
In particular, practitioners should seek disclosure of and consider:
- the instructions for use to surgeons by way of training and information as to the risks, complications etc;
- the warning to hospitals and trusts of the side effects etc contained within/alongside purchase contracts; and
- the product information leaflet for patients
All documents will have been prepared by the manufacturer and if incomplete, incorrect or with a failure to warn of certain side effects, there could be a cause of action against the manufacturers under the CPA. There have in the past year been numerous stories of manufacturers internationally failing to disclose known risks.
Section 4(1)(e) CPA provides manufacturers with the development risks defence which basically states that there must have been knowledge of the risks which caused the product to be defective at the time the product was developed, and such knowledge must be scientific and technical rather than industry knowledge.
The limits of the defence and precise test however are a matter of some debate as is shown out in various authorities.
Limitation
I see limitation as a potentially big issue in vaginal mesh cases. Practitioners will be well aware of the importance of bringing a claim before the limitation period expires. In clinical negligence cases, a party has three years to bring a claim from the date on which the cause of action accrued which in the main is largely straightforward. The claimant also has three years from the date of knowledge as defined in s14 Limitation Act 1980. The date of knowledge can be in dispute between the parties if the mesh insertion is several or more years prior to the bringing of the claim with the claimant stating that she became aware of the negligence within the last three years.
Practitioners on both sides will need to consider the claimant’s evidence, the story as set out in the medical records, as well as any other indicators of knowledge of negligence causing injury including affiliation with any mesh groups.
In product liability claims, there is the same test for discoverability as for clinical claims – three years from the date of the cause of action accrued or three years from the date of knowledge, whichever date is later. There is also the ‘longstop’ provision which puts the limitation period at ten years from the date when the product in question was last supplied by a producer/manufacturer, however this runs whether or not the claimant’s right of action has accrued and therefore will be relevant in all cases.
Defendants will no doubt have to consider the merits of raising limitation as a defence and putting the claimant to strict proof as to the date of knowledge.
Conclusion
To summarise, claimant practitioners should consider pursuing a claim in both clinical negligence and product liability when investigating possible negligence in mesh cases. Limitation should be considered fully if the date of knowledge is informing the limitation period, further the longstop provision for product liability cases needs to be explored if necessary. Although mesh for treatment of POP has been downgraded by NICE, there are hundreds of women around the country who have already had mesh implanted into their bodies with avoidable ongoing complications. It would be only just for these women to be compensated no matter where the liability lies.
Montgomery v Lanarkshire Health Board [2015] UKSC 11
Written by Mamta Gupta
This article was first published in Personal Injury Law Journal (April 2018) and is available at lawjournals.co.uk
