Surgical mesh

Surgical mesh is a medical device that is used when repairing weakened structures with the aim of providing additional support. It can be absorbable or non-absorbable. Non-absorbable mesh will remain in the body indefinitely so should be considered a permanent implant.

Hearing the stories of those harmed by surgical mesh

As part of its response to ongoing concerns with the use of surgical mesh, the Ministry of Health is wanting to provide an opportunity for people who have been harmed by surgical mesh and their families/whānau to tell their stories.

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Use of surgical mesh

Surgical mesh is widely used for hernia repair. It is also used in urogynaecological surgery, including in the treatment of stress urinary incontinence (SUI). Surgical mesh was previously used for repair of pelvic organ prolapse (POP) but since regulatory action was taken in December 2017 no surgical mesh products have been supplied for POP in New Zealand – see the Medsafe website for more information.

The use of mesh in surgery was introduced in response to the high failure rate of both initial surgery and revision surgery estimated at about 30%, with the aim of augmenting the surgery and reducing the failure rate.

Concerns about the use of surgical mesh

For many people, surgical procedures using mesh provide an effective form of treatment.

While many people who have mesh inserted experience no complications, a number do. Some experience complications immediately after their operation, while for others they develop years later. Complications may range from mild to debilitating and can have physical impacts and affect an individual’s quality of life.

Making an informed decision on the use of surgical mesh

Each type of mesh procedure carries its own risks and benefits. As part of the informed consent process, patients should be fully informed on what is involved in the procedure, the possible benefits and risks of complications, as well as any alternative treatment options (both surgical and non-surgical).

You have the right to seek a second opinion if you are not satisfied with the information you receive or would like further advice on your treatment options.

If you are concerned you may be suffering adverse effects following implantation of surgical mesh

If you have implanted surgical mesh and it causes pain, or you have concerns, contact the surgeon who implanted the mesh. Alternatively, you can contact your GP if you would like to be referred to another specialist in the use of surgical mesh

Consumers and health professionals are urged to report any adverse events experienced in relation to the use of surgical mesh to Medsafe. Further information, including reporting forms, is available on the Medsafe website.

Actions to monitor and improve the safety of surgical mesh

To minimise the risk to patients, while maintaining access to a treatment option which is appropriate for some women, on 24 September 2018 the Ministry wrote to district health boards (DHBs) asking them to undertake the following actions:

  1. assess surgeons undertaking urogynaecological surgical mesh procedures against credentialing guidance developed by the Australian Commission on Safety and Quality in Health Care, and
  2. ensure rigorous informed consent processes that include understanding of the associated risks.

If DHBs are not satisfied that their services or surgeons meet these standards, the Ministry has advised that urogynaecological surgeries involving surgical mesh should not take place.

Read or download the letter: Surgical mesh devices and ensuring patient safety (pdf, 3.3 MB)

Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) has been monitoring adverse event reports associated with surgical mesh and has provided a range of information and guidance to the health sector over the past nine years. More information on this can be found on the Medsafe website.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) which trains and accredits obstetricians and gynaecologists in Australia and New Zealand, has also published information regarding the use of urogynaecological surgical mesh implants on the RANZCOG website.

In December 2017, Medsafe used the provisions in the Medicines Act 1981 to request safety information from four suppliers of surgical mesh products in New Zealand. The consequence of this action was the removal from supply in New Zealand of all surgical mesh products for treatment of POP via transvaginal implantation and a single incision mini-sling for the treatment of SUI. Other products required changes to their Instructions for Use to amend the indications and/or add warnings before they could continue to be supplied in New Zealand. To date, New Zealand and Australia are the only two countries to take regulatory action on this issue – see the Medsafe website for more information.

The Ministry and Medsafe have also been working to implement the Government’s response to the report of the Health Committee on Petition 2011/102. A table outlining each of the seven recommendations, the actions to ensure the recommendations are implemented and a timeline is available on the Medsafe website.

The Ministry is also working with a Surgical Mesh Roundtable to gain input and advice on surgical mesh issues and actions. Representatives on the Roundtable include the professional colleges (RANZCOG, the Royal Australasian College of Surgeons and the Royal New Zealand College of General Practitioners), the Accident Compensation Corporation (ACC), the Office of the Health and Disability Commissioner, Mesh Down Under and the Ministry of Health (including Medsafe).

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