The AWHC has now received a response from Stewart Jessamine, the Group Manager of Medsafe, to its Official Information Act request for information on the use of three types of medical devices – the gynaecological mesh, PIP breast implants, and DePuy ASR hip joints.
The letter the AWHC received advised that the Ministry of Health/ Medsafe does not collect specific information on gynaecological meshes and is therefore unable to say how many women have had these implanted. There are a variety of surgical mesh products on the Web Assisted Notification of Devices (WAND) database.
PIP Breast Implants
There have been no notifications of PIP breast implants to the WAND database since it was established in 2004. “As notification to the WAND database is a legislative requirement for any medical devices intended for marketing in New Zealand it is believed that there have been no commercial importation of these devices into New Zealand since 2004 and the Australian supplier of the product confirmed this.”
Following publicity about the implants one woman did contact Medsafe and advise them that she had a PIP breast implant from a New Zealand-based surgeon in 2000. A second woman has now also come forward.
However since the letter was written, the NZ Association of Plastic Surgeons has revealed that some of these breast implants were imported privately and implanted.
DePuy ASR Hip Implants
The letter states that DePuy supplied a total of 525 ASR hip systems in New Zealand between 2004 and 2010, and that these were implanted into approximately 400 patients.
According to the letter, Medsafe has been active in ensuring that DePuy provided appropriate patient manage-ment information to surgeons who had used its product. The information was reviewed and approved by Medsafe and included a requirement to contact the patients affected.
There is however no mention of any monitoring by Medsafe to ensure that surgeons did contact their patients.
The WAND database is not publicly available as it was developed solely for use by the regulator for identifying those responsible for supplying medical devices in New Zealand. Medsafe claims it cannot make this information generally available.
As reported in previous articles in the AWHC newsletter, New Zealand has no pre-market assessment for medical devices. The letter claims that “all three devices had been approved for use by reputable overseas regulators using best-practice assessment processes. Procurement processes operated by New Zealand healthcare organisations also provide a level of scrutiny that provides some measure of protection against unacceptable products.”
It is now painfully obvious that these measures failed to protect New Zealand patients from faulty products.
Recent events continue to highlight the fact that neither the government or the Ministry of Health or any other government agency has done any-thing about ensuring that medical devices used in New Zealand are fit for purpose, have undergone clinical trials and are safe. This despite the fact that several major scandals have made the headlines in the media both here and internationally over the past six months.