With the news that over 800 women with vaginal mesh implants were planning to take legal action against the NHS and medical device manufacturers such as Johnson & Johnson – the largest maker of vaginal mesh – Lu Rahman looks at some of the issues surrounding this product.
Waiting Room
Vaginal mesh implants, made from polypropylene, are used to treat pelvic organ prolapse and incontinence following childbirth. However, some have been found to cut into the vagina, causing discomfort. Some of the women say they have been left unable to walk or have sex.
Bloomberg reported that Johnson & Johnson had been ordered to pay $20 million to a woman from New Jersey who said her TVT-Secur mesh had left her in constant pain.
Issues surrounding these implants aren’t new. According to the Aberdeen Evening Express, last year an allegation was made against Boston Scientific that it had used polypropylene from an area of China known for its use of counterfeit materials and that it had been used in mesh implants used in Scotland.
According to the newspaper, Boston Scientific said: “These allegations are simply not true. We stand by our products, our testing and verification of the Marlex used in our products, and we continue to reject any allegations that this resin is counterfeit or adulterated.”
In 2016 Johnson & Johnson agreed to pay over $120 million in relation to 2,000-3,000 US legal cases brought by women who claimed to have suffered organ damage due to vaginal mesh.
In the same year, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class ll) to a high-risk one (class lll) and gave manufacturers 30 months to prove that their products safe and effective.
In the UK, the debate continues. In The Guardian, Kath Sansom said: ‘The NHS and MHRA say the risk of complications with these operations is 1-3% but a report in the journal Nature by nine leading medics puts that risk at 15%. In the US the Food and Drug Administration recently released figures that said the trocar hooks used to implant the mesh cause injuries for up to 39% of women having a prolapse mesh and 29% of women having a mesh inserted for incontinence.’
Mediplus has been working with clinicians to develop a range of silicone pessaries which are an effective way to manage pelvic organ prolapse. The company is championing this non-surgical alternative – devices placed in the vagina which lift the walls and uterus back into place. The company says its products help more than 32,000 UK women each year.
Pelvic floor product manager, Francesca McCabe said: “Often, when women seek medical advice, they are offered surgery as the only solution without discussing the non-surgical options such as lifestyle, physiotherapy aided pelvic floor exercises and pessaries.”
Pessaries are non-invasive, improve the quality of life for the patient and it enable women to continue normal, everyday activities.
McCabe said: “We have had excellent results with many women reporting results similar to those expected with surgical correction. It has also shown a significant improvement in enjoyment of life and physical activities.”
Research carried out by the Mayday University Hospital, in Croydon, supports this view. The study evaluated prolapse, bladder, bowel and sexual symptoms 12 months after pessaries were inserted, demonstrating that vaginal pessaries were a simple and effective method of alleviating prolapse symptoms even in the longer term. It also concluded that it offered improvements in quality of life compared to the debilitating effects of pelvic organ prolapse. Overall, the research highlighted the effectiveness of pessary use.
Currently there are no UK protocols for pessary management. To address this, a James Lind Alliance Pessary Priority Setting Partnership has been set up by the Nursing, Midwifery and Allied Health Professions research unit at Glasgow Caledonian University to identify the top ten priorities for future research in relation to pessaries.
McCabe, who is a member of the Steering Group, added: “The research group is made up of people with relevant expertise, experience, and involvement with pessaries and by working together we can add to the current knowledge and evidence-base regarding pessary use.”
Andrew Loughney, medical director, Liverpool Women’s Hospital added: “Prolapse of the uterus or of the vaginal wall is very common, especially in women who have previously had children or who are older. Sometimes it needs no treatment but if it is causing symptoms, simple lifestyle changes and pelvic floor exercises can be effective.
“Pessaries can also be useful. They were first used more than two thousand years ago in the time of Hippocrates. They have an excellent safety profile and with the modern materials and designs now available, they can give significant long term benefit.”