Russian roulette with mesh
Surgical mesh procedures have left hundreds of Kiwi women suffering lifealtering pain and disability. Some mesh products were banned last year but last week a new Government proposal put the spotlight on surgeons, with their competency in the firing line.
Auckland woman Sam Bennett didn’t question the credentials of her surgeon when she went into hospital for a hysterectomy and transvaginal mesh (TVM) implant procedure in 2013.
Doctors told the mother of two they could fix her urinary incontinence problems with a vaginal sling. She had never heard of mesh and believed it to be a routine procedure.
She met her surgeon on the day. Minutes before she went under, the surgeon asked if she had been told about potential complications from the bladder sling.
‘‘I said no. And that was the end of the conversation.’’
So she didn’t hear about the risks of mesh erosion, infection, and chronic, life-changing pain. In the months following the procedure, Bennett said she felt a ‘‘heavy, period-like pain’’ but ignored it. But by early 2017 the pain had become excruciating and at a routine cervical cancer screen, her GP discovered the polypropylene mesh had eroded and was poking through into her vaginal canal. ‘‘It was excruciating. I’d just have to curl up in bed and take pain killers.’’ She was forced to abandon her realestate job and career.
‘‘I’d been doing that for 10 years and absolutely adored it but because of the pain I gave it up.’’
Bennett was referred to a surgeon who prescribed cream to fix the problem. When it didn’t work she was sent for another test and a hospital staffer told her about a surgeon who could remove the mesh. The surgery in March rid her of the pain but also left her incontinent. ‘‘Unfortunately my bladder gave up the ghost completely and so
it’s worse than it ever was, I have no control.’’
She has ongoing nerve pain and has suffered from deep depression throughout the ordeal.
‘‘I loved my career but I’m even looking at selling my house because I can’t financially . . . live.’’
Bennett has laid a complaint about the implanting surgeon with the Health and Disability Commissioner (HDC).
Last week the Ministry of Health asked district health boards (DHBs) to assess the credentials of surgeons against Australian standards for urogynaecological mesh procedures.
Bennett was not impressed. ‘‘It needs to be removed, it needs to not be around. It shouldn’t be put in anyone’s body at all.’’
SURGICAL SKILL QUESTIONED
From January 4 this year the Ministry of Health and Australia’s Therapeutic Goods Administration banned all mesh devices for another urogynaecological procedure, pelvic prolapse repair, and some used for SUI. But the supply of other mesh devices for SUI continued.
Last week the ministry applied a recommendation made by the Australian Senate inquiry on transvaginal mesh implants, published in March.
One of 17 recommendations was for health ministers to require credentialling standards developed by the Australian Commission on Safety and Quality in Health Care to be applied in all public hospitals and work with private hospitals to encourage the adoption of a similar requirement.
In July the UK government ordered an immediate but non-binding pause on mesh urogynaecological procedures in public hospitals until better protections were in place to prevent injuries. Conditions include ensuring only surgeons with appropriate training and experience perform the procedure.
The Ministry of Health last week sought an assurance that surgeons performing the procedures here are adequately trained and informing patients of risks. If DHBs can’t ensure this, the procedures should not go ahead, chief executive Ashley Bloomfield said in his letter.
A 2016 audit of transvaginal mesh procedures from one large urban hospital obtained by Stuff showed surgeons had varying levels of success in the procedure.
A ‘‘significant minority’’ of patients had persistent groin or vaginal pain two years after surgery and there was too much variation between surgeons in outcomes and re-operation rates, the report noted.
The procedures at the hospital were suspended for three out of five surgeons in the team while an improvement in credentialling and training took place.
The report author, whom Stuff agreed not to name, said the procedure should be done only by ‘‘a select group of highly trained practitioners’’.
‘‘The process . . . initiated at our DHB can and should be replicated throughout New Zealand so that we can give assurance to the public that we have a robust clinical governance structure for this type of treatment.’’
The report was presented this year to a surgical mesh working group, including representatives from the ministry.
A working group will begin work on a New Zealand credentialling system on October 8.
In the meantime Bloomfield has asked DHB surgeons to meet the Australian standards. These require urologists or gynaecologists without any experience of the procedure to have additional specialist training.
Those surgeons already performing the surgery would not need the specialist training but would have to show they had performed the procedure for two years and ‘‘can undertake the procedure safely and efficiently, and in cases where appropriately indicated’’. Surgeons were required to be performing at least 10 procedures a year.
HOW DO NZ SURGEONS RATE?
Most DHBs contacted by Stuff said they were confident in the credentials of their surgeons performing the surgery but were working with the ministry to ensure they met the Australian standards.
Christchurch Hospital clinical director of urology Sharon English said she was confident urologists performing the surgery would meet the Australian standards. But she could not vouch for other surgeons in New Zealand.
She supported the ministry’s action to check surgeons were practising safely and said it would reduce the number of surgeons implanting mesh.
Accreditation standards covered diagnosis of incontinence, which was also an important factor in avoiding adverse outcomes, English said.
‘‘We are trying to ensure that the right person gets the right procedure, so it’s more than just the surgery itself.’’
She said surgeons in her department shared their success rate with patients as part of the informed consent process. Across the department the success rate was 80 per cent, which meant the decision to have the procedure was challenging for patients.
‘‘I think patients have to get quite bad before they come forward for surgery. When they have a good outcome they say why didn’t I do that before?’’
English wanted to see specialist mesh clinics and a national registry established.
LISTENING TO MESH INJURED
Charlotte Korte from mesh support group Mesh Down Under said health authorities in New Zealand needed to listen to patients and take their complaints seriously.
Any woman considering a mesh procedure should ask about complications, she said. ‘‘It’s about knowing the actual risks, the potential risks and if these complications happen what can you do...asincanyou get the implant out fully and if you can’t what’s going to happen to me?’’
Patients should expect full and transparent informed consent.
Audits of mesh procedures were not standardised which meant assessments of outcomes varied from surgeon to surgeon.
In 2016 a survey of group members revealed a number of surgeons who had not informed patients of complication risks and had high complication rates.
Korte and fellow Mesh Down Under advocate Patricia Sullivan took their concerns to the Medical Council but were told patients would need to lodge complaints with the HDC themselves.
The HDC has received 33 complaints regarding surgical mesh since 2012 but has not investigated any of them. It has 11 currently ‘‘under assessment’’.
Sullivan said that was unacceptable and a breach of the patients’ code of rights.
‘‘How can you expect people who are so traumatised both physically and mentally to cope with fighting against and complaining to their GP, their surgeon, to ACC, to Medsafe, to HDC and to try and keep their family and relationships and income working?’’
A spokeswoman said the HDC ‘‘has a wide discretion as to what action he takes following an assessment’’.
‘‘HDC is aware of the concerns with surgical mesh products and the information provided to consumers. HDC continues to liaise with relevant agencies regarding this matter and attends the surgical mesh round table convened by the Ministry of Health to respond to this significant health issue.’’
MESH BACKGROUND
‘‘It needs to be removed, it needs to not be around. It shouldn’t be put in anyone’s body at all.’’ Sam Bennett
TVM surgery involves implanting a mesh ‘‘tape’’ or ‘‘sling’’ through the vagina to support the bladder neck for women suffering Stress Urinary Incontinence (SUI).
One in three women who have given birth will experience SUI – sporadic urine leakage that comes with certain movements such as coughing, sneezing or laughing.
For most women transvaginal mesh (TVM) procedures were successful but a minority experienced severe and lifealtering complications including erosion, infection, nerve damage and chronic pain.
As complications from the devices increased it became clear that they had not been subjected to rigorous testing before being launched onto the market for use.
An international backlash led by injured and disabled patients has resulted in class action lawsuits against some manufacturers and some products have been withdrawn by the manufacturers.
Surgeons have stopped using mesh devices to treat pelvic organ prolapse after investigations found a lack of evidence to support their use for those procedures, but three types of procedures with a Mid-Urethral Sling mesh device continue to be used to treat SUI when non-surgical options have failed.
A statement by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists says the ‘‘procedures have good success and safety profiles; however, surgical failures and complications are possible’’.
‘‘Patient factors and surgical experience’’ dictate the success or failure of the procedures, the statement says.