THE MINISTER FOR Health has praised the bravery of women affected by vaginal mesh complications as he confirmed today that a suspension of these surgeries will remain in place until the HSE implements a number of recommendations.
Thousands of women across the world have reported complications after procedures involving the use of vaginal mesh. In Ireland, a support group for affected women has more than 400 members and around 100 patients are taking legal action either against the State or their consultants.
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.
Irish women who have had surgeries using these implants have reported complications like chronic pain, reduced mobility and recurrent infections. Many have spoken of an inability to be intimate with their partners and some have had to have multiple surgeries to remove parts of the mesh after it eroded or moved inside them.
In November last year, Minister Harris asked the Chief Medical Officer (CMO) Tony Holohan to compile a report on the use of these medical devices. Harris today published the report, which found there is an evidence base to support the use of mesh in some circumstances:
However the report states that devices known as transvaginal mesh implants (TVMIs), used for the treatment of pelvic organ prolapse, are no longer regarded as appropriate as the first line treatment.
Holohan said these devices should only now be used in the management of complex cases, where other treatment options have failed or are not appropriate and where patients are fully informed.
Complications
In his report, he notes that it has been reported in a number of international safety reviews that complications relating to mesh devices may be “severe and life-altering” in a minority of women.
Mesh complications can be extremely difficult to treat in some patients because of the unique characteristics of mesh devices, which are designed to be permanently implanted.
Complications reported with mesh implants used in the treatment of both stress urinary incontinence and pelvic organ prolapse include pain, erosion through the vagina or surrounding tissue, infection, urinary problems, pain during intercourse, bleeding, organ perforation and neuro-muscular problems.
These complications risks apply to all mesh procedures, not just the TVMIs that Holohan has recommended restrictions on. He noted in his report that all of these complications also occur following non-mesh procedures to treat these conditions, except for mesh erosion.
Mesh erosion (for example through the vaginal wall) is one of the complications most highlighted in recent media reports. All synthetic meshes are associated with some risk of mesh erosion, reported by different studies in the reports in the footnotes below to occur in 2-4% of SUI procedures and 4- 19% of POP procedures.
Holohan in his report stated that many women who have undergone these procedures have had satisfactory outcomes and he highlighted the fact that a number of women suffering from these conditions have had their procedures postponed.
Informed consent is one issue many of the affected women have raised as part of their campaign. Members of the Mesh Survivors Ireland group have said their surgeons did not tell them beforehand that there was a risk – even a small one – that they could experience longterm pain or other complications after their procedures.
The report found some affected women were not even told that these devices had been used in their surgeries.
And Holohan said a significant source of distress was the difficulty in accessing timely and compassionate aftercare.
For some women, the response of clinicians to their concerns greatly added to their distress. Many women were of the opinion that they were not believed, that clinicians minimised or did not understand the severity of their complications, and there was a lack of confidence on the part of women that their treating clinicians had the expertise to assess and treat complications.
Women who suffered complications have previously described how their doctors rejected suggestions afterwards that their pain, discomfort or infections were related to the mesh device.
Among the 19 recommendations in the report is the necessity to develop patient information and informed consent materials and ensuring “timely, appropriate and accessible care pathways” for women with complications.
A number of women have travelled to the UK at their own expense for specialised scans and removal surgeries. Holohan has recommended the HSE ensure surgical professional training and multi-disciplinary expertise in units carrying out mesh procedures.
The Department of Health said a significant number of these recommendations are already underway by the HSE and the pause on all mesh procedures that was put in place on 24 July will not be lifted until key recommendations are in place.
‘Harrowing, deeply personal experiences’
Solicitor Melanie Power, who set up Mesh Survivors Ireland and who is representing many of the women affected, said the report recognises that concerns they raised in their campaign were valid.
“It recognises that the consent procedures and pathways were lacking and the HSE did not take heed of warnings of the device. It recognises under reporting by clinicians, a lack of readily available data on the number affected due to failings in the HSE system which all beg the question; how can complications rates as provided by Irish consultants be calculated?”
The suspension must continue until the science behind the device proves it is safe. Irish women deserve quality independent research before a lift on the suspension is considered.
Today Minister Harris paid tribute to the women affected by complications who had shared their personal stories and pushed the government on this review.
“The bravery, commitment and dignity shown by these women in sharing what were harrowing, deeply personal experiences are acknowledged and appreciated. The telling of their stories makes public what heretofore was often a private suffering,” he said.
“Their stories and their courage caused me to act and I want to thank the Chief Medical Officer for his work in addressing the understandable public and patient anxiety about this issue.
“A pause remains on the use of mesh procedures, pending confirmation by the Health Service Executive that the key recommendations have been implemented. I have already committed to meeting again with Mesh Survivors Ireland to discuss the report and I look forward to doing that in the coming weeks.”
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