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New surgical mesh safeguards put in place

Hon James Shaw

Acting Associate Minister of Health


25 September 2018 MEDIA STATEMENT

The Government has introduced strict new safeguards on the use of surgical mesh that are expected to limit its use in urogynaecological surgery.

“We all expect the health care system to keep us safe, yet too many women have suffered harm from the use of surgical mesh. These new safeguards are to give women greater confidence in our health care system”, said Acting Associate Minister of Health James Shaw.

“District Health Boards are to stop using surgical mesh in urogynaecological surgery unless they can guarantee that credentialing standards and robust informed consent processes are being met.

The Ministry of Health has today written to DHB chief executives, chief medical officers, and the professional colleges advising of new requirements to be in place before any surgical mesh surgeries take place.

These requirements are:

i. Assessing surgeons undertaking urogynaecological surgical mesh work against credentialing guidance developed by the Australian Commission on Safety and Quality in Health Care.

ii. Ensuring rigorous informed consent processes that include understandings of the associated risk.

“Only senior medical practitioners with the appropriate training, qualifications, experience, and fitness to practice will be able to continue using surgical mesh in these surgeries,” said Mr Shaw.

“DHBs have been asked to report back to the Ministry of Health by 8 October on their review of services and whether they will continue to undertake urogynaecological surgeries involving surgical mesh.



“Today’s announcement adds to the actions already taken in New Zealand to ensure the safety of patients and limit the use of mesh. In December, Medsafe removed multiple mesh products from the market.

“We are working closely with a Surgical Mesh Roundtable, which includes key groups such as Mesh Down Under, to progress a full work programme on surgical mesh.

“The use of mesh in urogynaecological surgery has been decreasing in recent years. This announcement today is about further reducing the risk to patients where surgical mesh remains a valid treatment option.

The Government is also investigating the option of a national registry to monitor the use of surgical mesh.

“While this option is being considered, DHBs have been asked to hold and maintain local registers, as a more immediate step, to collect information on surgeries involving surgical mesh. This will support identifying those most at-risk, patient follow up and ensuring robust informed consent processes are being followed.”

“The actions announced today are another important step in this government’s response to surgical mesh and minimising the risks to keep people safe,” said Mr Shaw.

Background

Credentialing is a process for assigning specific clinical responsibilities to health practitioners on the basis of their education and training, qualifications and fitness to practice within a defined context. The prime focus of credentialing is patient safety and it is a cornerstone of clinical governance. (www.health.govt.nz/publication/credentialling-framework-new-zealand-health-professionals).

The Ministry of Health is working with the Surgical Mesh Roundtable to develop guidance for the credentialing of surgical mesh services and surgeons in New Zealand. In the interim, DHBs have been advised to refer to credentialing guidance developed by the Australian Commission on Safety and Quality in Health Care (refer: www.safetyandquality.gov.au/our-work/transvaginal-mesh/resources/).

ends

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