In the United Kingdom one of the main experts on the use of vaginal mesh for medical treatment has expressed the opinion that devices such as these are unsafe for the treatment of incontinence.
Previously, chartered chemist Dr Chris DeArmitt has been an expert witness during court actions against vaginal mesh manufacturers and has helped over 9,000 women settle their compensation actions successfully.
Vaginal mesh devices are used in operations to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP); two conditions women can suffer from after natural childbirth or in their later years.
Minister for Health Simon Harris confirmed the suspension in Ireland of all surgical procedures involving these devices until the HSE implements 19 recommendations that were made by the Chief Medical Officer in Ireland, Dr Tony Holohan, at the end of 2018.
Dr Holohan’s report concluded that the devices referred to as transvaginal mesh implants (TVMIs), used for the treatment of pelvic organ prolapse, can no longer be regarded as safe or acceptable for first line treatment. He said that these devices should only now be used in the management of complex cases, where other treatment options have failed or are not appropriate.
He said that there is enough research to support the use of mesh as a mid-urethral sling for stress urinary incontinence or as an abdominally placed mesh for management of prolapse.
Previously in Ireland, during 2017, several legal actions were submitted. These arose, according to legal representatives for the women in question, after the women who were suffering from pain viewed new reports from the UK detailing legal actions in that jurisdiction. Before this they had, according to the legal counsel, been unaware of any possible link between their health issues and the device.
Earlier in in 2019 the US Food and Drug Administration outlawed the sale and distribution of all mesh that was to be implemented in relation to pelvic organ prolapse. This decision was taken following the highlighting on many safety concerns by the general public. More than 100,000 people are suing in the United States in relation to injuries and illnesses that, they claim, came about due to the use of vaginal mesh.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said the FDA needed evidence that the devices worked better than the other procedure for POP that does not use mesh. The alternative procedure uses native tissue to repair the prolapse. He said: “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions.”