Surgical Mesh Patient Safety Concerns

Lead petitioner, Sally Walker and Charlotte Korte co petitioner, believe “the surgical mesh harm speaks for itself, the terrible suffering that is happening is avoidable, and it needs to be stopped.

Today we are speaking up because mesh injured will be mortified at the response from the Health Select Committee (HSC). We are extremely disappointed, we do not feel this report reflects that level of harm that is occurring, and we want the voices of mesh harmed to be heard. We want mesh injured to know we will not give up.”

A response to Sally Walker’s petition was delivered to parliament by the Health Select Committee on the 30th June 2023. Sally’s petition requested a suspension of surgical mesh procedures for stress urinary incontinence, because of serious patient safety concerns, and the ongoing harm. These same procedures were suspended in the UK and are permanently banned in Scotland.

The HSC has noted that the Ministry of Health were “already investigating whether a suspension should be implemented”. They recommended to the Government that instead, “the Ministry of Health, the New Zealand Medical Council and relevant medical colleges should investigate how it could effect a time limited pause”.

Sally Walker is shocked and disappointed, she says “the 68 women I am supporting will be absolutely gutted and it will be heartbreaking for me to have to tell them. I would like to think the Director-General of Health, Dr Diana Sarfati who will now decide on if the suspension will be implemented, will do what is right, fight for patient safety. Suspending mesh procedures will give women trust, hope and safety for now and in the future. “

Co petitioner, Charlotte Korte says, “So many lives have already been destroyed, the Health Select Committee has failed to take decisive action and it is understandable mesh injured will feel utterly let down, the committee members had the chance to stop the suffering and prevent others from the same fate.”

Both Sally and Charlotte feel this report is inexcusable, “the committee has ‘passed the buck’, fobbed off this responsibility to the same health entities who for years have been unable to stop this trauma and suffering. Where are the specific recommendations that one would expect from the Health Select Committee? Where is the evidence that the committee took this issue seriously, other than to listen to the people who presented and read their submissions. What conclusions did they make?”

The Green Party clearly support a stronger direction, they “believe that the harm being caused is not acceptable, and they are not confident patient safety can be assured.”

Spokesperson Jan Logie says “there is sufficient acknowledgement of serious harm to necessitate a suspension. The Green Party believes the Government needs to follow England and Scotland and step in and prioritise patient safety until there is a nationwide system of rigorous credentialling that has been completed, and high vigilance scrutiny placed on all non-mesh pelvic floor procedures.

The Green Party are “concerned the recommendation that the Ministry of Health work with the relevant colleges and the Medical Council of New Zealand to investigate how it could effect a pause essentially gets the same body who have procrastinated for so long to make the final decision.”

Relevant information:

Final Report https://selectcommittees.parliament.nz/v/6/e1b69424-9a28-4291-846c-08db78e3ac9a

• Nationwide credentialing for surgeons implanting mesh has not started. There was no information provided to the Health Select Committee on when it will begin, how long it will take, or when it will be completed.
• Just 12 of New Zealand’s most experienced mesh surgeons have been credentialed, with only 6 meeting the minimum standards for removal. There is no clarification on what specific procedures these 6 surgeons have been credentialed for.
• With the credentialing process not yet completed, there was still no clarity provided to the Health Select Committee on what specifically is being done in the interim to protect patients, to keep people safe from harm.
• The petitioners want assurance that Te Whatu Ora/Ministry of Health will be able to prevent surgeons from operating uncredentialled going forward, and for more information to be provided to show how they will do this.
• Chief Medical Officer (CMO) Joe Bourne confirmed that the Education and Harm Prevention Program for surgeons had not begun, but talks were happening, and a meeting was organised at the end of May, this meeting “was to agree a way forward”.
• The Ministry of Health and the medical colleges did not provide any evidence to show that there was requisite training/upskilling happening in both mesh and non-mesh procedures currently to the Health Select Committee.
• Surgical mesh is still being used for pelvic organ prolapse in New Zealand, it is placed abdominally, these procedures are not banned.
• The two mesh centres set up in Auckland and Christchurch will not accept women suffering with mesh complications if only had a rectopexy mesh device has been implanted, these mesh injured patients will not have access to the wrap around services available. The clinics will accept mesh injured patients who have a rectopexy device if they have also had a stress urinary incontinence or pelvic organ prolapse device implanted.
• A surgical mesh register was first considered in 2018 and is still being considered by Manatū Hauora/Te Whatu Ora. CMO Joe Bourne confirmed that currently they prefer the Australian Monash (APFPR) surgical mesh register. Te Whatu Ora/Manatū Hauora are looking at how the register will fit the New Zealand context. The APFPR register is not mandatory, surgeons can opt in or out of the register, and it could potentially take years before surgeons and hospitals are able to sign up to it. The number of procedures being added to the register i increasing.
• Alongside the request for a suspension, both Sally and Charlotte asked for the reporting of surgical mesh adverse events to be made compulsory, for a change in the legislation to ensure a surgical mesh register would be mandated, that it would not be a voluntary opt in opt out decision for surgeons to join the register, and for high vigilance to be placed on non-mesh procedures, to keep people safe.

Green Party Response

“Green Party of Aotearoa New Zealand differing view The Green Party supports a stronger direction to suspend the implantation of vaginally inserted mesh sling for stress urinary incontinence (SUI). We are concerned the recommendation that the Ministry of Health work with the relevant colleges and the Medical Council of New Zealand to investigate how it could effect a pause essentially gets the same body which has procrastinated for so long to make the final decision.

We note that we were told concerns that a pause could reduce access to a treatment that works for many women were also raised in Scotland ahead of the decision to implement a suspension, and the adverse impacts were not realised. The Greens believe the potential for adverse impacts could be mitigated with high-vigilance scrutiny and proactive engagement and promotion of physiotherapy. We also believe there is sufficient acknowledgement of serious harm to necessitate a suspension. Progress towards credentialling has been very slow and credentialling of those implanting mesh is still “some way away”.

We have been unable to obtain any information at all regarding how long it will take to credential surgeons nationally, or when this process is expected to be completed. Recent reporting on the first round of assessments reported only 12 surgeons applied to be credentialled, for the removal of mesh implants, and only six of them were found to meet the minimum standards. This suggests that surgeons have been practising for the last few years without the requisite competencies despite surgeons being assessed against Australian credentialling guidelines in 2018. We are also concerned that there appears to be nothing to stop non-credentialled surgeons in the private sector from continuing to work.

This means we are not confident patient safety can be assured. The Green Party believes the Government needs to follow England and Scotland and step in and prioritise patient safety until there is a nationwide system of rigorous credentialling that has been completed, and high vigilance scrutiny placed on all non-mesh pelvic floor procedures. The harm that is being caused is not acceptable.”

International expert opinion provided to the HSC - Dr Wael Argur

“The risk of chronic pain and most other long-term complications are because of the device itself rather than surgical skill. He emphasised the importance of surgical experience but noted that it is not associated with reductions in device-related chronic pain and other long-term conditions. Dr Agur explained that an inadequate surgical technique by people who are not credentialed is mostly associated with intraoperative complications, such as bladder injury. However, he said that this type of injury does not appear to have long-term complications because it can be diagnosed and repaired during surgery. Dr Agur noted that the United Kingdom pause on mesh remains despite it having a robust surgical training programme in urogynaecology and female urology. The United Kingdom

has also established that mesh MUS surgery should only be performed by credentialled and experienced surgeons. According to Dr Agur: the pause is partly based on the understanding that improving surgical skills could not adequately mitigate the device-related risks.”

Therapeutic Products Bill — Second Reading, relevant statements

RICARDO MENÉNDEZ MARCH (Green): We have examples of where there are necessary and actually urgent regulations that we need to put in for devices that have proven time and time again to be incredibly harmful. Surgical mesh is a massive example of this, of why this bill actually will help enable finally having a regulatory framework—and the Green Party feels we can move towards banning the use of surgical mesh—and that is one that has proved to be incredibly difficult to regulate. We haven't made significant progress, despite years of campaigning by many people who have shown the harms that such a device can create. So with this bill, I do hope that we can move towards finally banning things like surgical mesh. Menéndez March, Ricardo - New Zealand Parliament (www.parliament.nz)

Ayesha Verrall stating the surgical mesh devices are inadequately regulated - We need legislation to regulate the use of medical devices that are currently inadequately regulated, and the example of the harm caused by surgical mesh is one area where these changes are needed. Therapeutic Products Bill — Second Reading - New Zealand Parliament (www.parliament.nz)

Written Question- 22887 (2022). Dr Shane Reti to the Minister of Health (04 Jul 2022): How many people, if any, have been diagnosed with pelvic mesh related complications per year in the past 5 years?

Hon Andrew Little (Minister of Health) replied: The level of detail requested has not historically been reported to, or recorded by, the Ministry of Health. Providing the Member with this information would require the Ministry of Health and Health New Zealand to undertake a substantial manual collation exercise and divert staff from their core duties. In accordance with Speaker’s Ruling 185-6, I consider that the time, and hence the expense, of answering the Member’s question is not in the public interest.

NZ Herald article- In Her Head - surgical mesh: How Govt failed to protect women - NZ Herald

Petition Sally Walker- Petition of Sally Walker: Suspend the implantation of mesh sling for stress urinary incontinence - New Zealand Parliament (www.parliament.nz)

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