Many women are now suffering from complications caused by transvaginal mesh implants. Matthew Tebbutt, solicitor in the Clinical Negligence team, looks at the issues.
Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse (POP) and stress urinary incontinence in women. There are several different types of mesh but transvaginal tape (or TVT) is one of the most common and has been used to treat stress incontinence across Europe, the USA and Australia since the early 2000s.
Prior to its use, surgeons used open surgical procedures to treat POP and stress incontinence. However, the use of mesh was seen as preferable as it allowed for quicker operating times, reduced recovery periods and avoided the risks associated with open surgery.
Initial clinical trials of the mesh found that the procedure had a high success rate and offered lower risks. However, as time goes by, there is a significant body of evidence showing that the long-term complication rates are significantly higher than those initially reported. In the UK, NHS data suggests that one in 15 women has to have their implant surgically removed.
The potential for serious complications is even more concerning when one considers that a 2014 government report estimated the procedure was performed on about 17,000 women per year suffering stress incontinence. The number of vaginal mesh implants used for prolapse peaked around 2009, with 3,200 implants sold to hospitals.
Stress incontinence treatment
NICE, the body responsible for reviewing treatment within the NHS, issued updated guidance for treating stress incontinence in September 2013. In its guidance, it stated its view that the use of mesh for treating stress incontinence was merited. The guidance also noted the potential risks associated with the procedure, including erosion. However, it confirmed that the merits of the procedure outweighed the risks.
Mesh Oversight Group Report
On 25 July 2017, NHS England published the Mesh Oversight Group Report. The report identified several areas to be looked at and improved, including informed consent, surgical experience and the tracking of complications; they did not suggest any steps to prevent the ongoing use of mesh.
In response to the NHS England report, John Wilkinson, Director of Devices at the Medicines and Healthcare products Regulatory Agency, said:
“What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances. This is supported by the greater proportion of the clinical community and patients […] In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.”
Therefore, while reports of complications continue to occur the current medical guidance is that, when used correctly, the use of mesh is acceptable and will continue.
Recent news reports have suggested that NICE will be imminently updating their guidance in relation to the use of mesh products but only for the treatment of prolapse. Reports have advised that the new draft guidance states there are “serious but well-recognised safety concerns” and that “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity”.
The final guidance with full guidelines for the use of transvaginal mesh in prolapse and incontinence patients will be published in 2019.
Potential for problems with transvaginal mesh
As with any surgery or medical procedure, there is a risk of complications. The following are some of the complications that could occur with a TVT procedure:
- Bladder perforation during the operation;
- Severe bleeding;
- Bladder infection;
- Passing urine frequently;
- Vaginal wall erosion;
- Bowel and nerve trauma.
If you have any questions about any of the issues raised in this article or would like to discuss a potential clinical negligence claim, then please do not hesitate to get in touch with us by emailing Clinical Negligence partner Joanna Laidlaw at [email protected].