Revised: 25 September 2018
Medical Devices
Surgical Mesh Implants - Actions taken by Medsafe
Medsafe has been monitoring adverse event reports received associated with surgical mesh implantation and has provided information and guidance.
11 May 2018 the Director-General of Health wrote to all Chief Executives of District Health Boards, and private surgical hospitals to remind them that surgical mesh remains an important clinical issue, to update them on recent developments and to describe actions to be taken in response to the information provided in the letter. A copy of this letter is published on the Medsafe website. http://www.medsafe.govt.nz/hot/alerts/surgical-mesh-letter-to-NZ-College-of-Surgeons%May%2018.pdf (2 pages, 755KB, pdf)
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 of some products from use in New Zealand, and the other products involved required changes to the Instructions for Use to amend the indications and/or add warnings before they could continue to be marketed in New Zealand. Link to press release. (2 pages, 924KB, pdf)
September 2016 Medsafe commenced work on the implementation of the recommendations in the Health Committee report on surgical mesh. Further information is published at http://www.medsafe.govt.nz/devices/surgical-mesh-recommendations-implementation.asp
2015 Medsafe wrote to all Chief Executive Officers of District Health Boards and private surgical hospitals to advise them of the latest information available at that time about the use of surgical mesh, particularly for urogynaecological applications. A copy of this letter is published on the Medsafe website. http://www.medsafe.govt.nz/hot/alerts/Surgical_Mesh_Implants_September_2015.pdf (2 pages, 1374, pdf)
2014 Medsafe responded to a request from the chair of the Health Committee requesting information on surgical mesh.
2013 First publication of the “ Adverse Event Reports Relating to Surgical Mesh Implants, Summary of reports received by Medsafe ”, published.
2009 Medsafe wrote to the Chief Executive Officers of
hospitals (both private and public) known to be using surgical mesh outlining
the key points from the 2008 Medsafe review, and supporting the guidance
provided by RANZCOG. A copy of this letter was also sent to RANZCOG and
is published on the Medsafe website.
http://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe2009.pdf
(2 pages, 83KB, pdf)
2008 , Medsafe was sufficiently concerned that it conducted its first review of the use and adverse events associated with the use of surgical mesh. This investigation included a literature review of papers published on this subject.
The report was submitted to the Medical Device Incident Review Committee, an Australian advisory committee with representatives from several Professional Colleges, for review along with a report on the same subject from the Therapeutic Goods Administration Medical Device Incident Review and Investigation System. The committee concluded that the return of symptoms and erosion (into the vagina or rectum) were the most common problems associated with these devices and that there was a need to explain this to the patient in terms of the success rate they could expect. It also noted that training of surgeons was important to the success of this new type of surgery.
A copy of the Medsafe report is available for download from the link below. Note that some information has been removed from the report as permitted by the Official Information Act 1982 in order to protect the privacy of individuals.
Medsafe Surgical Mesh Report - 2008
(4 pages, 773 KB, pdf,)
