THE UK’S HEALTH watchdog has recommended restricting the use of vaginal mesh implants for treating pelvic organ prolapse.
There has been global scrutiny surrounding transvaginal mesh devices, which are used in surgeries to treat two conditions women can develop following natural childbirth: stress urinary incontinence and pelvic organ prolapse. These procedures have been carried out on women in Ireland since the late 90s and are still performed today.
Health Minister Simon Harris recently asked the Chief Medical Officer to compile a report on the use of transvaginal mesh implants in Ireland, after complications suffered by a number of Irish women were highlighted by TheJournal.ie.
These complications include migration of the mesh, which can then protrude through the vagina, chronic pain, and recurrent urinary tract infections.
In guidelines issued today, the UK’s National Institute for Health and Care Excellence (Nice) said these procedures should only now be used for research purposes. It said current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows “there are serious but well-recognised safety concerns”.
Evidence of long-term efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.
Nice said all adverse events involving the medical devices (including the mesh) used in this procedure should be reported to the UK’s Medicines and Healthcare products Regulatory Agency.
“Further research should include details of patient selection, long-term outcomes including complications, type of mesh used and method of fixation, and quality of life.”
Vaginal mesh in Ireland
Last year in Ireland, 728 patients had a procedure for pelvic prolapse. The HSE has said it does not separate data for each operation to treat prolapse, so it is unclear how many of these involved the use of mesh.
The UK watchdog’s guidelines do not make any recommendations in relation to mesh devices used to treat the other condition treated with mesh – stress urinary incontinence. The most common procedure involves the use of what is called a mid-urethral sling, which supports the bladder.
Previous studies have shown that there is a higher success rate and lower complication rate for these procedures than there is for mesh operations to treat prolapse. Experts have said this is because operations to treat prolapse require the use of a larger amount of the polypropylene mesh.
However, campaigners are calling for an all-out ban on the use of these devices until further study has been completed.
In November, a Canadian mesh campaigner died, having suffered serious complications after a procedure to treat stress urinary incontinence. 42-year-old Chrissy Brajcic, from Ontario had her implant removed, but her pain had continued and she suffered regular infections.
She became resistant to antibiotics and was hospitalised in October this year suffering from sepsis. Brajcic died on 29 November.
‘The pain frightens me’
The Irish women who have experienced issues with mesh devices also had procedures to address stress urinary incontinence, rather than prolapse.
Janet Roche, 48, had her implant removed this year after seven years of chronic pain following her surgery.
However, she said she is still experiencing pain and has been told she will probably have chronic pain for the rest of her life.
“It’s constant pain medication, morning and night. Sometimes a sleeping tablet is the only thing that will work when it gets really bad. The pain frightens the life out of me, she told TheJournal.ie.
“I’ve gone from being a participant in the family to someone who is just being looked after.”
The Health Products Regulatory Authority (HPRA) has received six incident reports in relation to these devices and is asking women who have suffered complications to report it to them, which they can do through this form.
If you’ve been affected by this issue, we want to hear your story. Get in touch at michelle@thejournal.ie.
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