Medsafe releases its updated Adverse Event Reports Relating to Surgical Mesh Implants

News article

07 August 2018

Medsafe has today released an updated Adverse Event Reports Relating to Surgical Mesh Implants.

Due to a change in how information is provided to Medsafe, an additional 962 events which were not previously recorded in this report are now included.

This brings the total reported number of adverse events relating to surgical mesh since 2005 to 1070.

The adverse event rate associated with surgery in any particular year for urogynaecological procedures remains reasonably steady at between 1% and 3% since 2005.

The adverse event rate associated with surgical mesh used for hernia repairs varies between 0.5% and 2%.

“This updated criteria will give the Ministry a much more accurate and robust view of complications arising from surgical mesh use,” says Ministry of Health Chief Medical Officer Dr Andrew Simpson.

In October 2017 ACC provided Medsafe with summary information on all treatment injury claims where surgical mesh had been implanted during surgery. Prior to this date, detailed information was only provided on treatment injuries determined by ACC to be serious and sentinel. The updated information includes all surgical mesh treatment injury claims submitted to ACC.

The Accident Compensation Act 2001 requires information on treatment injuries determined by ACC to be serious or sentinel to be notified to the appropriate government department or regulator. Information on such treatment injury claims has been supplied by ACC in the past. ACC has agreed to supply Medsafe with ongoing information on all treatment injury claims relating to surgery where mesh was implanted during the surgery.

The report shows a continued decline in the sale of surgical mesh sold for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The adverse event rate associated with surgical mesh used for hernia repairs varies between 0.5% and 2%.

“The use of mesh in these surgeries has declined since 2013, and I would expect to see that continue with Medsafe’s actions this year and in late 2017 to limit the availability of mesh to be used in these surgeries,” says Dr Simpson.

The Ministry is continuing to work with Mesh Down Under and the Surgical Mesh Roundtable to further assist future work relating to surgical mesh.

You can find the report on the Medsafe website (PDF, 293 KB).

Background:

Although all treatment injury claims relating to surgical mesh have been included in the report’s statistics, not all treatment injury claims may be a consequence of the mesh.

Claims made to ACC are in relation to a treatment injury. Some treatment injuries such as post-surgery pain, or infection consequent to surgery may not be ‘adverse events’ associated with mesh implantation, rather expected possible consequences of surgical procedures in general. As it is not possible to identify whether the treatment injury claims can be directly attributed to the use of surgical mesh, these claims have been included.

While it is acknowledged that there will be some unreported cases, it is also acknowledged that some patient’s adverse event may be included more than once in the statistics if it was reported from more than one source. Some patients may also have more than one ACC claim relating to the same mesh surgery.