Chartered chemist Dr Chris DeArmitt, an expert witness who has helped over 9,000 women settle their vaginal mesh compensation actions successfully in the United Kingom, has expressed the opinion that devices such as these are not safe for the treatment of incontinence.
Dr DeArmitt commented, during an interview with Sky News, that “there are two main reasons why any plastics material expert will tell you just obviously that this is a bad material and I have never heard anyone who disagrees with me. I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”
Vaginal mesh devices are usually used in operations to address stress urinary incontinence (SUI) and pelvic organ prolapse (POP); two conditions women can develop a condition for after natural childbirth or later in life.
Speaking previously, Minister for Health Simon Harris said the suspension in Ireland of all surgical procedures involving these devices would remain until such time as the Health Service Executive implements 19 recommendations from Chief Medical Officer in Ireland, Dr Tony Holohan, at the end of 2018. The report said that the transvaginal mesh implant (TVMI) devices, 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 not been successful or are not deemed appropriate.
Holohan said that it is still appropriate to use mesh for a mid-urethral sling for stress urinary incontinence and also as an abdominally placed mesh for dealing with prolapse.
There were a number of compensation claims submitted in in Ireland during 2017. This came about after the women in question, according to their legal teams, who were dealing with pain issues witnessed news programmes in the UK describing legal actions thee. They had been unaware of the link between their pain and and the vaginal mesh devices device prior to seeing the reports.
The US Food and Drug Administration(FA) in the USA made the sale and distribution of all mesh that was to be implemented in relation to pelvic organ prolapse illegal in 2019. These steps were implemented after a public campaign that involved over 100,000 people are suing in the United States in relation to injuries and illnesses. They allege that their illnesses and pain arose from the use of vaginal mesh devices.
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.”