One particular time in hospital, I was so upset I just wanted to get out of it. I walked out with a drip in one hand and catheter in the other, out to the front of the hospital and realised I couldn’t go anywhere and just sat down on a bench and started crying because what could I do? I was in this situation and I felt like it was a never-ending cycle.
MARGARET BYRNE, A 65-year-old mother-of-three has become used to doctor appointments, endless prescriptions and daily injections. Back in 1999, she was suffering from stress urinary incontinence as a result of natural childbirth.
Her consultant asked her if she would try a new procedure, which would involve inserting mesh tape, called a mid-urethral sling that support the urethra. Byrne said she was told “it would be quick, easy, 20 minutes, home the same day and a very short recovery time as opposed to six weeks recovery with the other one”.
I didn’t hear of any negatives from him about the tape.
After the surgery, Byrne said she developed an infection which was cleared up with an antibiotic. However, after the healing process, when she and her husband resumed sexual relations, they realised something was wrong.
He could feel something very sharp and so could I. So, on inspection, which is not really something you want to do, I found that part of the tape had cut through my vagina and was now sticking there, sharp-edged.
‘Each one was unsuccessful’
She returned to her surgeon who recommended another procedure to “pull skin over it and sew that in place and that would cover the tape”.
Again, on trying to resume sexual relations after the healing time it was the same story. The tape had eroded into my vagina again. This continued, I went back and back and had a series of operations over three years and each one was unsuccessful.
Eventually Byrne asked her consultant to remove the problematic transvaginal mesh device. In her final surgery, he performed a different procedure to address urinary incontinence.
Although there was an improvement with her incontinence issue, the mother-of-three has suffered from regular urinary tract infections since her last surgery.
“Also, I have a problem with my bones which the GP and my bone consultant can’t explain. My pelvis broke in two places, right and left side last year [and there had been] no trauma,” she said.
She is on daily injections for this issue and she said her GP is trying to determine whether there is any connection with her surgeries.
Chronic pain
The US Food and Drug Administration reclassified the transvaginal mesh implant as a high-risk device in 2012 and some 100,000 women there have filed lawsuits.
Three group companies of manufacturer Johnson & Johnson are fighting a class action from 800 women in Australia who claim they suffered serious complications following these procedures.
The Australian government is also holding a Senate inquiry into the use of these devices.
Johnson & Johnson maintains it has acted ethically and responsibly in the research, development and supply of these products.
In 2012, one of its subsidiaries Ethicon stopped sales of four of its vaginal mesh products, but the company insisted at the time that safety was not the reason.
It is only in the last year that the issue was highlighted in the UK with coverage in particular from The Guardian newspaper, which revealed NHS figures suggest one in 15 women who underwent a mesh procedure later had to have the implant either partially or fully removed.
A number of support groups, like Sling the Mesh, have been set up online and many of the women who have experienced complications as a result of the procedures have described experiencing chronic pain and having difficulty walking.
Other reported issues include headaches, lack of energy, discharge and bleeding.
In some cases, problems started a short time after the surgery, in others, it was years afterwards.
Many said they were not warned of the potential complications and that their concerns were dismissed by their doctors when issues with the mesh began after their surgeries.
‘I was never told about complications’
Now women in Ireland who experienced complications from these procedures have started to come forward.
Janet Roche is another one of these patients.
The 48-year-old had the mesh implant in 2010 to try to tackle her stress incontinence.
She had suffered incontinence after her first two children and after she had two more, the problem worsened.
“I just happened to mention it to my doctor in passing when I was down for something else and he said ‘we’ll have a look at it anyway’. It was in the hospital that he mentioned the surgery. They said there was significant leakage, but that they had a solution,” she told TheJournal.ie.
Roche said she was told she could go on medication for a couple of years, but that she would ultimately need the surgery anyway to properly address the problem.
“I didn’t like the idea of taking medication for two years. At that time I wouldn’t have even had Disprin in my house. They never actually told me what the procedure was. I was so naive when I think about it now – I didn’t even ask. They said they were going to lift the bladder up, but they never mentioned how they were going to do it and mesh was never mentioned at that stage. Certainly I was never told about complications.
“I don’t take chances, I’m not a lucky person and I never have been, so if they had mentioned for one second any of these risks, I would never have gone ahead with it. I have four kids, I wouldn’t have taken that risk.” At the time, her children were aged 12, ten, five and three. About six weeks after the procedure, Roche started to experience intense pain.
I was crying on the couch, I was in bits. I can’t describe the pain. They did an ultrasound and said my bladder wasn’t emptying, it hadn’t been emptying properly since the surgery. They said there had obviously been an overcorrection so I’d have to retrain my bladder, catherising myself four or five times a day.
“I was put on long-term antibiotics, but nothing worked, nothing worked for the pain.
“They tried to put it down to other things along the way and they said it’d settle down or I was still healing. They said I could have interstitial cystitis. I was afraid it could be cancer because I had some of the same symptoms.
“In seven years I haven’t had a urine sample that didn’t have blood in it. Sometimes they said it was thrush, or maybe I was being too intimate with my husband. Once they asked me was I sure I actually was in pain, like it was in my head.
“Within months I was begging them to reverse it. For seven years they bounced me between two departments.”
It was only in June last year that Roche said a consultant confirmed her pain was caused by the mesh implant. The mesh had migrated into her urethra. These devices are designed to fortify the natural tissue, which grows into and around the tape. This makes them incredibly difficult to remove in their entirety.
She had a partial removal in April this year and has been told the surgeon took out as much as was possible.
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.”
Though the 48-year-old said she has suffered terribly over the last seven years, it is the impact on her family she is most angry and upset about.
My relationship with my husband is probably the hardest thing to bear. He’s been fantastic, he’s never complained, but it all falls on him.
Since I had this done, my poor husband, at this point it must be nearly two years since [we had sex]. Whenever I wasn’t in pain, I didn’t want to risk triggering it and he was reluctant to touch me because he didn’t know if he was doing something to hurt me. Even with it partially removed, we’ve tried and he can feel something there hurting him when we try to be intimate.
I don’t feel like a wife anymore. I’ve said to him I would understand if he left me because I can’t give him that. He said there is no way he’d look at another woman.
‘It broke my heart’
Roche also said she feels as though she has let her four children down. She agreed to have the surgery because she thought she would be able to be more active with her kids if her incontinence was cured.
Even now she is frequently bedridden.
“Sometimes the only relief I got was lying on the bathroom floor. My children used to find me there and they’d put a blanket over me. There were times when I tried so hard not to cry in front of them,” she said.
“My youngest is only ten and she worries about me so much. If I look anyway off at all she’s asking should she get my tablets or ring her daddy. She shouldn’t know all of that, she shouldn’t see that. She doesn’t get excited about going anywhere because we have to see on the day how I feel.
“I’ve gone from being a participant in the family to someone who is just being looked after.
“I even missed my sister’s wedding – that broke my heart. They took this gorgeous picture at it for me, all my sisters and brothers and my mam and dad. I can’t even look at it.”
Roche also had to give up a job she loved, working in customer care for McDonald’s.
“They were so good all through this and kept the job open for me to go back, I couldn’t have asked for better. I’ve been put on invalidity pension now, I just wouldn’t be able to work.
It sounds dramatic to say it ruined my life, but from my perspective, the life I have, I don’t have anything like the life I had before.
Success rates
For stress urinary incontinence, there are a number of options and physiotherapy is the recommended first line of treatment.
The mid-urethral sling procedure took over from colposuspension, which involves stitching the neck of the bladder to ligaments attached to a pelvic bone. The sutures used in this procedure are made of the same material as the mesh implants. Success rates vary from 85% at one year to 70% at five years.
Other treatments include bladder neck injections (30-50% cure at one and four years), fascial slings (66% success at two years) and a laser treatment which is currently being trialled.
A decade-long independent study of 60,000 Canadian women published in 2015 found the majority of women who had the mid-urethral sling surgery (which involves the mesh implant) for stress incontinence had a good outcome from the procedure.
However, one in 30 required a second surgery to either fix or remove the mesh. Patients of lower-volume surgeons were 37% more likely to require a follow-up surgery.
A study of 81 trials published in Cochrane this year found over 80% of women with stress incontinence are cured or have significant improvements with either of the two operations. It found that there was erosion of the tape into the vagina in 2% of the 12,113 cases.
The authors of this research pointed out that their results were based on “moderate quality evidence” as most trials did not describe their methods clearly. They also said there are only a limited number of randomised controlled trials that have published data beyond five years after surgery and this means evidence of the long-term efficacy lags behind the short and medium-term.
While these short and medium-term trials have found low complication rates for implants that are used to treat stress incontinence, there is growing evidence that the efficacy is lower for devices used in women with pelvic prolapse – and complication rates are higher.
A report by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) said there was a need for further improvement in the composition and design of synthetic meshes, in particular for female pelvic organ prolapse surgery.
It also recommended that non-invasive solutions should be considered before resorting to surgery and the amount of mesh should be limited where possible.
‘Quicker return to normal activities’
Suzanne O’Sullivan, consultant gynaecologist and urologist and President of the Incontinence Foundation of Ireland (CFI) has stressed that patients should be fully informed of both the benefits and risks involved in any surgery.
Her organisation recently published a note on its website to address the concerns of patients who have seen the media coverage of issues with these devices.
“They [the mesh slings] have been shown to be as effective as more invasive traditional surgery with major advantages of shorter operating and admission times, and a quicker return to normal activities together with lower rates of complications. This has resulted in MUS [mid-urethral sling] becoming the operation of choice in Europe, Asia, North and South America and Australasia for treatment of stress urinary incontinence with several million procedures performed worldwide,” CFI said.
Speaking to TheJournal.ie, O’Sullivan said no operation “is safe or complication free” and they all carry short and longterm complications rates.
“The complications and success rates differ with each procedure. Other factors include patient and surgeon variables. Some patients are low risk, slim, and have simple pure stress incontinence and will inevitably have lower complication rates and higher success rates. Obesity, smoking, age, diabetes, previous surgery and mixed incontinence will make surgery more risky and less likely to give complete cure and this is the case with all surgical options,” she explained.
“Whilst each patient differs in terms of symptoms, background medical history, optimal treatment approaches may differ. Relative to other procedures mid urethral slings have been shown, in large studies from all over the world, to be no less safe (and usually more safe) than other procedures and with improved short, medium and longterm outcomes.”
Though O’Sullivan said mesh erosion is the only complication that does not occur with all other operations for stress incontinence, she pointed out that the sutures used in these other surgeries can also migrate into other organs.
“In our unit, we strive to ensure our patients fully understand their treatment. We fully explain each procedure, the alternatives, and the risks and benefits, and we answer any questions they may have. Information leaflets are given and consent forms are signed before surgery in every instance,” she said.
“We list the potential complications of surgery on consent forms signed by the patient, in keeping with best medical practice.”
The consultant said all clinicians have a responsibility to advocate for women who suffer complications of surgery, and all patients who present with life-altering symptons.
We must ensure that accurate and clear information is provided, which will allow women to be confident in choosing the best procedure for them. Open, balanced and transparent discussion is the best approach for all concerned.
Regulation
The Health Products Regulatory Authority said it has identified two unconfirmed reported incidents in respect of transvaginal mesh devices and vaginal mesh implants.
“The HPRA is in regular communication with the Department of Health in relation to the health products regulated under its remit; this includes transvaginal mesh devices and vaginal mesh implants,” the authority told TheJournal.ie.
“The HPRA has provided the Department of Health with an overview of this issue, including the numbers of incidents reported to the HPRA and details of relevant publications in relation to the safety assessment of these devices.”
Responding to a query from this website, the Department of Health said: “The HSE has not made the Department aware of any particular issue regarding the clinical use of this device.
“We understand from the Health Products Regulatory Authority that it has identified two unconfirmed reported incidents in respect of transvaginal mesh devices and vaginal mesh implants.”
In response to a number of questions from this website, the HSE explained it does not collate data on the number of patients who have had mesh procedures. It does collect information on surgeries for stress incontinence and prolapse, but it does not differentiate between procedures that use mesh and those which do not.
It did not address questions about whether it believed these devices are safe or whether it was aware of the international scrutiny and court action involving mesh procedures.
“It is the responsibility of the consultant to explain to patients the risk involved with this procedure, as with any procedure,” it said in a brief statement.
“The HSE does not collate data for the private sector so cannot comment on the treatment of women in private hospitals.”
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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