Ireland suspends transvaginal mesh procedures

Earlier this week, Ireland temporarily suspended all procedures using transvaginal mesh devices to treat stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals, according to a government release from the country. Minister for Health Simon Harris announced the pause, saying that the Department Chief Medical Officer requested the pause in use of the devices following a review by the Dept. of Health, HSE and the country’s Health Products Regulatory Agency. The suspension is set to stay in place “until a set of conditions to mitigate the risks of injury are met,” according to the announcement. “There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS. It is important that this be addressed as comprehensively as possible. A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice,” Harris said in a press release. The Dept. of Health said that the HSE will look to confirm implementation of certain recommendations related to surgical training, informed consent ant development of an agreed dataset of mesh pr...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Women's Health Source Type: news