New Zealand's healthcare watchdog is examining claims surgeons implanted mesh into eight women's bodies without their informed consent, leaving them with severe injuries.
The Health and Disability Commission (HDC) is scrutinising the claims three years after a Victoria University report for the Ministry of Health, which included women describing their trauma from surgical mesh as "medical rape".
The HDC is also looking into six separate complaints from women who say they have been harmed by mesh, relating to potential breaches of the agency's standard of care.
All 14 complaints were received between 2019 and this year. Seven were made this year.
One is under formal investigation, five have been referred to the investigations team to consider whether an investigation should be undertaken, and eight are at various stages of the initial assessment process, with the majority awaiting a response from the surgeon.
Health and Disability Commissioner Morag McDowell told the Herald there was serious public concern patients could have been harmed by surgeons who were not appropriately qualified to perform these complex procedures.
Surgical mesh is used on women to repair urinary incontinence and pelvic organ prolapse (POP) - a common childbirth injury. While it can be used for other parts of the body and on men, it has frequently been reported to cause harm when used in women's pelvic operations, particularly when inserted through the vagina.
ACC payments for surgical mesh injuries have soared from $500,000 in 2017 to $5.1 million last year.
After many years of complaints, Associate Health Minister Dr Ayesha Verrall last month released a framework to assess all surgeons using mesh in New Zealand to ensure they were appropriately qualified and experienced.
Before this, there was no national system in place to ensure correct procedures were followed.
A well-informed source, whose name the Herald agreed to protect, said women as young as 35 continued to be seriously injured by surgical mesh, despite the promised new standards and a warning to DHBs from director general of health Dr Ashley Bloomfield four years ago to minimise the risk of harm from the medical device.
McDowell said the surgical mesh stories she was aware of were "incredibly harrowing", and the complaints were only a small snapshot of those harmed.
More than 600 people, mainly women, told their stories as part of the ministry's report into surgical mesh problems three years ago.
In a speech at a medical conference last month, McDowell compared the harm from surgical mesh outlined in the report to the so-called "unfortunate experiment" at National Women's Hospital, which led to the 1988 Cartwright Inquiry.
"Its content resonates with the Cartwright inquiry, which included concerns about the informed consent process and the extent to which relevant information was or was not conveyed to patients to allow an informed choice," McDowell said.
The Cartwright inquiry investigated a 1966 study, led by Dr Herbert Green, which intentionally did not treat women with major cervical abnormalities, without their consent. Twenty years on, many developed cervical cancer and some died.
'The mesh was rotting inside of me'
The Government's new standards for surgeons using mesh have come too late for many women who feel their lives have been robbed after the device was inserted into their bodies. Some claim the procedure was done without their informed consent.
"The mesh was rotting inside of me," Sally Walker, 72, told the Herald.
Walker's insides were so badly damaged after surgical mesh was incorrectly implanted into her body by Auckland doctor Paul Macpherson that she was forced to get her bladder removed to save her life and to have her vagina sewn closed.
She's not alone. Merrissa Haa, 47, says she pleaded for mesh not to be inserted into her pelvis but she claims that her surgeon - also Macpherson, who has now retired - insisted it was tape, which was different and therefore safe. Her medical records show she and a doctor at her local DHB clearly stated in writing that she did not want mesh used in her operation.
Haa said she was left disabled after the surgery, and medical records show she received an ACC payout for being injured by mesh treatment.
"I remember waking up screaming, 'I've had four children and I would rather give birth to them all now than be in this pain'," Haa said.
Another woman, who didn't want to be named, complained to the HDC that she signed a patient consent form for a hysterectomy - the removal of the uterus - but when she woke up, mesh had also been grafted into her, leaving her with severe vaginal pain for nearly a decade. She was seen by a different surgeon, who no longer practises in New Zealand.
Macpherson retired in 2019 and has a medical condition.
The Herald put detailed questions about Walker's account of her treatment to the Macpherson family and received a reply from solicitors Wotton and Kearney.
Senior associate Kate Wills said Macpherson was now retired and was unable to defend himself against the claims because of his medical condition.
She asked the Herald not to name Macpherson or mention his health issues. To publish these details would be a breach of fairness and privacy, she said.
However, Walker told the Herald she wanted to talk about Macpherson's treatment openly because he introduced the procedure at Auckland DHB and trained other gynaecologists still practising. She and other patients were also worried that he may have been affected by his illness before his retirement only three years ago.
Former Health and Disability Commissioner Ron Paterson - now a professor of health law and policy at the University of Auckland - said he was aware there remained "significant concerns" regarding women being harmed by gynaecological surgeons who were not properly trained to select appropriate patients and implant mesh without causing harm.
"My understanding is the issues are ongoing, and that's deeply concerning," Paterson said.
Auckland DHB, which employed Macpherson until his retirement in 2019, also asked the Herald not to name him. A spokeswoman said medical decisions were often made by a multi-disciplinary team, which involved a range of health professionals working together to make decisions on patient care, rather than just one doctor.
The number of health professionals involved in the decision-making varied on a case-by-case basis, the spokeswoman said. She could not confirm if there was a multi-disciplinary team making decisions on Haa's care to implant mesh.
Making sure surgeons are appropriately qualified
Documents released under the Official Information Act show director general of health Dr Ashley Bloomfield emailed all district health board chief executives, in September 2018, seeking "support of actions to minimise risks [from surgical mesh] to patients".
The director general's email included a letter from the ministry's chief medical officer at the time Dr Andrew Simpson advising they were working on requiring surgeons to have an appropriate qualification to use surgical mesh for urogynaecological procedures.
Last month, Ministry of Health chief medical officer Robyn Carey told the Herald that while the ministry was working on a New Zealand framework to ensure all surgeons using mesh were appropriately qualified, the expectation was that any specialist using the device had been assessed against the Australian Framework.
However, when the Herald asked Carey how many surgeons had the Australian accreditation, she was unable to answer. She said it was the employer's and surgeon's responsibility to ensure they were appropriately credentialed and competent.
The OIA documents show while some DHBs - such as Bay of Plenty and Lakes - say they
would not be performing any urogynaecological mesh procedures for the time being, other DHBs - such as Auckland - responded to Bloomfield's 2018 email saying they already had qualified specialists undertaking surgical mesh procedures.
However, some of the specialists named as having "appropriate qualifications" have also been blamed by affected women for causing them severe harm.
McDowell said the HDC followed up Bloomfield's letter towards the end of last year with an email to all DHB chief executives and private hospitals, because she and her staff were worried about surgeries allegedly being performed without informed patient consent.
"We wanted to understand if any urogynaecological surgeries involving surgical mesh were being performed and we also wanted to ensure that if they were being performed that the informed consent booklet, created by [support group] Mesh Down Under, was being used to inform women of the complications, risks, benefits and questions they can ask," McDowell said.
"That was followed up and as I understand it there has been some work looked at addressing the issues that came out of that from a ministry level."
Carey said the rollout of the new framework would involve an assessment of practitioners' background, capability, and surgical outcomes - including complication rates, patient-reported experience and outcome measures - by a panel of experts.
A national credentialing committee would lead the framework and it would be supported by international experts, Carey said.
"Once there are credentialed experts within New Zealand, most pelvic floor reconstructive and urogynaecological procedures will be undertaken locally or regionally."
Carey said that where the committee has concerns regarding a practitioner's competence or conduct within that practitioner's scope of practice, they may notify the Medical Council.
"If the practitioner has not undertaken a credentialing process or if they are working contrary to their credentialing process recommendations, the Health and Disability Commissioner may decide that individual is in breach of the Code of Health and Disability Services Consumers' Rights.
"It is an employer's responsibility to ensure that any surgeons carrying out relevant procedures have been credentialed to do so," Carey said.
Other countries stop using surgical mesh, NZ does not
In 2018, a Ministry of Health restorative justice inquiry heard from 600 people, mainly women, injured by surgical mesh.
Many suffered chronic debilitating pain, erosion, infection and were left unable to walk without aid, have sex or exercise. Some tried to take their own life as a result, the report said.
While other countries, such as Scotland and England, put a pause on the use of pelvic surgical mesh in 2018 - which continues today as surgeons couldn't guarantee its safety - New Zealand did not follow suit.
"We've been debating surgical mesh for over a decade and still women continue to be harmed by it," said Charlotte Korte, who was injured by surgical mesh and has been advocating for other women whose lives she claimed have been destroyed by the device.
Associate Health Minister Dr Ayesha Verrall said the harm from surgical mesh was an issue the Government had taken seriously.
However, when the Herald asked if she had full confidence that further harm from surgical mesh had been stopped, or at least minimised since the director general's email to all DHBs in 2018, she couldn't directly answer.
Instead, she said the Government had already undertaken steps to ensure past wrongs were rectified, including an apology by ACC and changes to ACC's processes.
"Recommendations from the Hearing and Responding to the Stories of Survivors of Surgical Mesh report are progressing with all but three of the 19 recommendations underway or in the process of being implemented," Verrall said last month.
"Everyone in New Zealand has the right to health services of an appropriate standard. Where care isn't to an acceptable standard, they've been treated unfairly or harm has occurred, they have the right to complain," she said.
Likewise, the minister said all medical and healthcare professionals could report any harm or concerns about the standards of care by colleagues and were encouraged to raise a complaint through the HDC and the relevant registration authority.
"If patients or their whānau feel harm has been done to them they can raise a complaint with the Health and Disability Commissioner.
"It is the responsibility of the Health and Disability Commissioner and relevant medical registration authorities to review complaints and ensure a full and robust investigation takes place if complaints warrant this action."
Mesh errors 'common'
In the OIA documents released September 2018, Auckland District Health Board's chief executive Ailsa Claire said surgical mesh had been used as a treatment option at the DHB's Women's Health department since 1997 after they were introduced by Macpherson who had trained in Europe and Australia.
"He became a preceptor for Gynaecare retropubic midurethral sling or TVT and has trained many gynaecologists since in the safe placement of these products," Claire said.
"Dr Paul Macpherson is one of the most experienced gynaecologists in New Zealand at removal of vaginal mesh having performed this operation as either partial of complete removal since prior to mesh kits being available (ie prior to 2005) when gynaecologists and urologists were placing meshes fashioned from those used for hernia repair as nothing else had worked," Claire said.
In 2012, the Herald quoted Macpherson in a story about surgical mesh being the subject of international lawsuits and health warnings as the device was still being implanted in hundreds of New Zealanders.
At the time, the gynaecologist said he repaired at least one mesh-related surgery error each week.
Macpherson, who was a member of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, supported the ongoing use of mesh to repair severe or recurring tissue weakness.
Macpherson said, seven years before retiring, the way the mesh was implanted into the body could cause complications.
"If it is too close to the bladder it will irritate it. If mesh is put in too tight it will stay there. It is a difficult operation to do and best done by people who have undergone training and have done a reasonable number of them."
He said at the time that only about 10 doctors in New Zealand were trained to operate with surgical mesh and there were strict guidelines on who could use it.
In Her Head is a Herald campaign for better women's health services. Health reporter Emma Russell investigates what's wrong with our current system, and talks to wāhine who have been made to feel their serious illness is a figment of their imagination or "just part of being a woman".