Patients who say surgical mesh has made their lives a 'living hell' question why it's still being used
It's been eight years since Lyn Blucher has had sex.
"My husband has been really good about it," says Blucher, fighting back tears. "It's painful for me, which makes it painful for him, so we stopped eight years ago."
There are other things she's stopped, too. Blucher, 68, has no control over her bowel or bladder; she can never make it to the toilet in time.
"We had to sell our business, because it involved me driving and I just couldn't do it, so we retired early. We had plans to travel, but I did one flight to Singapore and it was awful – it was so embarrassing and I had to change almost constantly," the Whangaparaoa grandmother says.
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Some days, she's too ashamed to leave the house. Instead, the formerly active business owner spends hours each day on chat rooms, speaking to other women worldwide who are suffering similar complications from operations involving surgical mesh.
Severe pain and bleeding. Constant bladder infections. Nausea. The frustration of having no doctors believe them, or being told they are hypochondriacs. Ongoing, expensive attempts to remove the mesh.
Blucher is one of an untold number of women in New Zealand who have suffered catastrophic injuries from the insertion of surgical mesh to treat pelvic organ prolapse and urinary incontinence – common effects of pregnancy, childbirth, and ageing.
There are 367 victims in the New Zealand support group she's part of, Mesh Down Under, which also includes some women and men who have suffered complications as a result of surgical mesh used in hernia repair.
ACC have received 780 claims for mesh injuries since 2005, at a cost of $12 million to the taxpayer.
But an investigation shows the true extent of injury is likely much higher. It found:
* Four New Zealanders have died from complications after mesh surgery;
* Government agencies do not know how many surgeries are being done, and what the outcomes are;
* Select committee recommendations last year have gone largely unheeded;
* Calls are mounting for a Commission of Inquiry, like the Australian senate inquiry that is underway;
* It's understood a mesh manufacturer has paid secret compensation to one group of victims.
Surgeons say mesh is very effective for thousands of people, and that patients are warned it comes with complications just like any other surgery.
But Blucher, who has been left in debilitating pain after her surgery to treat a minor bladder problem eight years ago, wants to know when the toll will be high enough for concerns to be taken seriously.
WHAT IS SURGICAL MESH?
Thousands of patients are having mesh implanted for hernia repair, pelvic prolapse and urinary incontinence every week.
For most, the procedures are successful but for others – statistics vary, but up to one in 10 who undergo these surgeries – the results are devastating.
Hernia repair for defects in the stomach wall is one of the most common surgical procedures in New Zealand.
The Association of General Surgeons doesn't know how many are completed each year but president Andrew Moot said it would be "many thousands".
Most hernia repair in New Zealand is done with mesh during keyhole surgery: mesh replaces tissue and reinforces muscle to stabilise the stomach wall.
But there are detractors within the surgical community.
A large Danish study of more than 3000 incisional hernia patients published in February found major complications for hernia mesh repairs were much higher than for non-mesh repairs. Up to five per cent of mesh patients had major complications compared to less than one per cent of non-mesh patients.
Given a choice, Gerald Young, an Auckland GP with a specialist interest in the surgery, would opt for non-mesh over mesh for himself.
"Why take the risk of ongoing groin pain if you don't have to?"
When it comes to transvaginal mesh (through the vagina mesh ), researchers now say the life-altering complications that arise when it goes wrong mean using it should not be the first choice.
After widespread use from the late 1990s, it has now been established the mesh products were not backed by clinical trials, were not regulated, and required no specific training.
Pelvic organ prolapse is a common condition affecting hundreds of thousands of women worldwide. About half of all women who have had a child have some level of prolapse, and one in five women will need to seek medical help.
Outcomes of mesh complications for affected women in Medsafe reports include rectal damage, infection, holes in the bladder and urethra, vaginal wounds, fecal incontinence, leg, bowel, and pelvic pain, and ongoing pain, nausea, bleeding and discharge. The mesh is difficult to remove, and this does not always work. "Severe pain and bleeding following intimacy," one unknown woman told Medsafe in 2014. "Erosion causing pain, discharge, infection," report after report states.
In Australia, an inquiry is underway after Victorian Senator Derryn Hinch told Federal Parliament that transvaginal mesh devices rivalled Thalidomide as one of Australia's worst health scandals. Court action includes one of the largest medical civil cases in Australia, starting in July and expected to run for six months, brought by 450 women against global pharmaceutical giant Johnson & Johnson.
While some doctors say it is not used as frequently in New Zealand as it was in the past, there is no real record of the extent of mesh use – and the scale of the problem.
HOW HIGH IS THE TOLL?
In New Zealand, treatment injury claims to ACC for mesh complications have doubled in the past three years – with 301 claims accepted since 2014 and a further 138 declined. The majority of these were for vaginal repair and surgery.
Around 20 per cent are declined. ACC admit this data is likely incomplete, as mesh injuries are not specifically coded.
Regulation of mesh implants include adverse event reporting to Medsafe, but it is not mandatory.
The Government regulator has 131 reports on record since 2005. Only three of these have been made by manufacturers, three by healthcare professionals, and 26 by suppliers. The rest are from patients and ACC. The majority were for transvaginal implants.
Further investigations revealed Medsafe has allowed more than 56,000 devices to be supplied on the New Zealand market since 2005, without requiring any proof of clinical safety or efficacy.
The Ministry of Health admits it has no idea how many people are having mesh implanted nationwide, because they do not collect this data. Some District Health Boards record it, but this is not consistent.
Royal Australasian College of Gynaecology and Obstetrics New Zealand committee chair Ian Page says there is a 15 per cent risk of complications from pelvic organ prolapse mesh procedures compared with about 5 per cent for urinary incontinence surgery.
Non-mesh prolapse surgery involved using sutures, or stitching, but had a higher rate of recurrence, Page says.
"Unfortunately the reality is all treatments have the potential for causing problems and there's no escaping that."
Patients should be fully informed by surgeons about the risks of mesh, Page says, but he can't be totally confident this is happening because he does not personally monitor their consultations.
The College provides clear guidance and advice for surgeons on informed consent, he adds. In their guidelines, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists have warned against the use of transvaginal mesh for prolapse, because of insufficient testing and concerns of injury and long-term safety.
In an editorial last year, Auckland gynaecologist Professor Cindy Farquhar said the gynaecological and surgical communities needed to learn from the experience of mesh harm and make sure patients were protected in future.
WHAT IS BEING DONE TO PROTECT PATIENTS FROM HARM?
A Health Select Committee inquiry in 2014 produced seven recommendations, endorsed by Minister of Health Jonathan Coleman in August last year.
None of them required mandatory action but instead committed to "encourage", "discuss" , "investigate" and "suggest" improvements to monitoring, coding, training and reporting for mesh procedures and complications.
Setting up of a registry and prior approval of medical devices have been put on hold until the government progresses a wider review of therapeutic goods legislation late this year, a Ministry of Health spokeswoman says.
Government representatives have met with medical colleges on three occasions to discuss informed consent, setting up a registry and ongoing education, Medsafe general manager Chris James says.
James says improved adverse event reporting forms have now been developed and are available on the Medsafe website.
The gynaecologists' association is backing the call for a registry but Royal Australasian College of Surgeons New Zealand executive director Richard Lander says this will be expensive.
No government funding has been "sought or allocated" for any of the recommendations including the establishment of a registry, James adds.
'AN INSULT TO MESH SURVIVORS'
Two-and-half-years after they launched a petition for an independent inquiry, founders of supporters group Mesh Down Under, Carmel Berry and Charlotte Korte are deeply disappointed.
The select committee's recommendations, which emerged from their petition, were "weak" – and for them to be ignored is an insult to mesh survivors, they say.
"Very little has been achieved," Korte says. "We relied on the government to take the mesh issue seriously which, going by this response, they didn't."
They say it should be mandatory for ACC, surgeons, GPs and manufacturers to report adverse events, there should be an implant register for all mesh products, and more stringent safety regulations.
Their calls are echoed by Wellington's Wakefield Hospital gynaecologist Hanifa Koya, who sees dozens of women a year for transvaginal mesh removal surgery. Not only should a registry have been set up long ago, but surgeons needed to be supporting all claims, she says.
"I just feel so gutted that even after the Cartwright Enquiry we are still letting these women down."
Auckland Women's Health Council advocate Lynda Williams has been taking phone calls from those whose life has been irreversibly changed for more than ten years. "This is yet another women's health issue which is downplayed and dismissed."
"There's a tsunami of cases."
At 68, Lyn Blucher will never get back the years of her life she has lost to mesh.
But she says she won't stop fighting until surgeons stop using the mesh. "It's just ruined my life. It's made my life hell."
She just hopes the government may take action to save other women from the same misery.
- Sunday Star Times