The chief medical officer for the Department of Health has requested that all procedures involving transvaginal mesh devices be paused unless it is “clinically appropriate” or “safe” to use the device, the Minister for Health has said.
In a statement released on Tuesday, Simon Harris said his department’s chief medical officer had requested that the HSE refrain from using the device, which is used to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP), following a review by the Department of Health, the HSE and the Health Products Regulatory Agency.
The announcement comes a fortnight after the UK government accepted a recommendation to temporarily ban the use of vaginal mesh implants for women with urinary incontinence until March 2019. The Independent Medicines and Medical Devices Safety Review found that the use of the mesh must be stopped until steps had been taken to mitigate the risks to patients.
"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, " said Mr Harris. "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."
The minister noted that it was widely accepted that the use of the synthetic mesh for women suffering from symptoms of SUI has provided a “more effective and less invasive form of treatment than traditional surgical procedures”. He said the UK National Health Service recommendations arose because of a “lack of certainty or confidence that critical clinical governance measures to assure the safety of mesh procedures are demonstrably in place”.
“The Department considers that similar concerns in relation to the visibility and consistency of such measures apply equally in the public health system here.”
The pause in using the mesh will remain in place until the HSE confirms it has implemented recommendations relating to surgical training, informed consent and the development of an agreed dataset on mesh procedures, said Mr Harris. The statement from the department underlined that the pause was “not a blanket ban on relevant procedures” and that for some patients the use of mesh may be the only viable treatment option.
Members of the Mesh Survivors Ireland group met with the minister last month to call for a suspension of the mesh device and to discuss how the treatment of women suffering from SUI or POP could be improved. "Irish women deserve the same care as those in the UK," said Melanie Power, founder of Mesh Survivors Ireland after the meeting. "Until the government take action to suspend mesh for stress urinary incontinence, Irish women will continue to be subjected to the risk of lifelong disabling complications from a procedure often described to patients as gold standard and a quick-fix."
Surgical mesh is a medical device made from a synthetic material has been in use since the 1950s to repair abdominal hernias and since the 1990s in treating male and female SUIs, female POPs and bowel disorders.
POP, which affects women who have given birth, is when one of more of the organs in the pelvis slips down from their normal position and bulge into the vagina. SUI is the unintentional loss of urine and occurs when the muscles that support the bladder weaken.
Patients in Ireland affected by the cancellation of the procedure are due to be contacted by the HSE and any patients with concerns are advised to contact their consultant’s clinic.
