The recent report by the BBC in their Victoria Derbyshire programme highlighted the plight of many women who had mesh implants in prolapse surgeries. Hundreds of women are taking legal action in clinical negligence and product liability claims against the NHS and manufacturers of the mesh.
What is a mesh?
A mesh or vaginal tape is a plastic medical device used by surgeons to treat stress incontinence and pelvic organ prolapse, conditions that can commonly occur after childbirth. The implants have been widely used in the UK, Europe and US but the Scottish government recommended suspension pending further evidence and a number of the health boards have stopped using mesh implants altogether.
There are a lot of different meshes available. Some are permanent and some are absorbed by the body after a while. Some appear to have lower risk of problems than others.
Pros and cons of using a mesh
Inserting any artificial material into the body has disadvantages. The material can become infected. Scar tissue can form around the mesh making the vagina stiffer and causing pain, especially during intercourse. Overtime, the mesh can wear through the tissues so that it pokes through the vaginal skin, or through the wall of the urethra, bladder or bowel. This is called erosion and can occur many years after the mesh has been put in. If erosion occurs, it often needs further surgery to remove parts or all of the mesh by surgery which can be complicated.
Surgeons have had concerns for many years about the potential for meshes to cause complications in some women. The FDA (US Food and Drug Administration) who regulate mesh in the US have classified vaginal mesh as a “high-risk device” but it is still used by surgeons NICE have also published advice for doctors about using mesh in the UK. The MHRA (Medicines and Healthcare Products Regulatory Agency) has received many complaints about mesh implants. But so far they still believe that the product is safe and effective for the majority of women, and the benefits outweigh the risks. Currently there are around 100 different types of vaginal mesh implants available in the NHS but surprisingly, none have been recalled.
Although for the vast majority of women, mesh implants can be a safe and effective form of treatment, on the whole, around 5 in 100 women who had mesh implants have chronic pain. Around 6 in 100 women develop mesh erosion after having mesh inserted during a vaginal repair. Around 15 in 100 women experienced dyspareunia after they had mesh implants inserted. These are not insignificant figures. The Cochrane Review in 2016 suggested that mesh anterior repairs had a higher risk of later complications than non-mesh repairs.
In contrast, prolapse, although distressing to many women, is not a dangerous or harmful condition. So before prolapse surgeries, surgeons would need to take the patient through the procedure and to explore other surgical or non surgical options and to weight the risk of having complications from the mesh against the symptoms from prolapse. It is important to consider the advantages and disadvantages of using mesh in a vaginal repair carefully before going ahead with the surgery.
Defects in the mesh may give rise to claims based in product liability. Lawsuits had started in the US against manufacturers (such as Boston Scientific and Ethicon/Johnson & Johnson’s) resulting in significant damages awarded to the claimants. Juries concluded that the devices were defectively designed and there had been no warning about the side effects of mesh failure. We hope that the verdicts would encourage British women to seek compensation for life-changing injuries and health problems they suffer after being fitted with mesh implants.
The products that are held as defective or subject to settlement in the US would include:
• Obtryx sling
• Pinnacle pelvic mesh repair kit
• Gynecare TVT-O sling
• Prolift, Prolift M+
• TVT Secur pelvic mesh device
In addition to product liability claims, even for products that are not deemed “defective”, it is still possible to claim against the NHS for:
1. Lack of treatment choice – NICE guidelines states that patients should be offered a trial of supervised pelvic floor muscle training of at least three months duration as first-line treatment, before any surgery is contemplated. In addition, invasive procedure should only be considered after a MDT review. Failure to offer conservative management could be a breach of duty of care if the patient can prove that she would have avoided undergoing any surgery at all.
2. Lack of adequate or any informed consent – NICE guidelines states that a patient considering prolapse surgeries should be advised of all available procedures (including those not involving the use of implants) and risks and benefits of different treatment options. A patient should also be advised of the lack of long-term outcome data for vaginal mesh. In short, a patient is now required to be involved in the decision making process. A breach of this duty could mean that patient could have elected to have alternative surgery.
3. Negligently performed surgery. This can occur if the surgeon inserts the tape incorrectly or in the wrong place.
Thomson Snell & Passmore is currently representing patients whose vaginal mesh and tape were either fitted incorrectly by surgeons or they had not been advised of the potential risks and the other surgical or non surgical options. Both product liability and clinical negligence claims are subject to limitation. Any woman who had vaginal tapes for stress incontinence or vaginal meshes in prolapse surgery and is experiencing any discomfort should contact their GP or surgeon. They should also consult a solicitor for any potential claim.
(Information is correct at time of publishing April 2017.)