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Suspension of Vaginal Mesh Device use to Continue – Minister

Posted: September 5th, 2019

Minister for Health Simon Harris has said that the suspension in Ireland of all surgical procedures involving these devices will continue until such time as the HSE implements 19 recommendations that were made by a report from the Chief Medical Officer in Ireland, Dr Tony Holohan, at the end of 2018.

Vaginal mesh devices were previously implemented in operations to address stress urinary incontinence (SUI) and pelvic organ prolapse (POP); two conditions women can experience after natural childbirth or in their later years.

Dr Holohan’s report found that that the device (transvaginal mesh implants – TVMIs) used for the treatment of pelvic organ prolapse should no longer thought of as safe or acceptable. He added that these devices should only now be used to address complex cases, where other treatment options have failed or are not sufficient.

In the United Kingdom one of the chief experts on the matter has said that he feels the devices are unsafe for the treatment of incontinence. Chartered chemist Dr Chris DeArmitt, who has helped over 9,000 women settle their compensation actions successfully, said that there is adequate 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.

During 2017 in Ireland a number of legal actions were submitted following the airing of new reports from the UK on legal actions in relation to suffering caused by the use of vaginal mesh to treat incontinence in that jurisdiction. The women involved, according to their legal representatives, had previously been unaware of any possible link between their health issues and the device.

The US Food and Drug Administration (FDA) outlawed the sale and distribution of all mesh that was to be implemented in relation to pelvic organ prolapse in 2019. Over 100,000 people are taking a legal action in the United States in relation to injuries and illnesses that, they believe, arose due to the use of vaginal mesh.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health 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.”

Categories: Medical Negligence Claims Ireland

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