60 Minutes - TV3 on 20 May 2012
UPDATE ON USE OF MEDICAL DEVICES IN NZ
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.
BREAST IMPLANTS REVISITED
Breast implants are once again at the centre of a major medical disaster story after it was revealed that implants manufactured by a French company contained a substandard, industrial grade silicone.
The history of breast implants is littered with flawed devices since silicone implants gained popularity in the early 1960s as a way of augmenting breast size.
The latest breast implant scandal is centred round Poly Implant Prothese (PIP), a leading international maker of breast implants founded by French entrepreneur Jean-Claude Mas. The implants were among the cheapest in the world, and were recently found to be filled with silicone made for mattresses rather than medical use.
Investigations began last year into the PIP which manufactured 100,000 breast implants a year and was exporting 80% of them. The implants came under suspicion after doctors reported an abnormal number of rips and leaks in the implants.
While regulators in Britain said tests had shown no evidence of a potential for cancer or chemical toxicity of the industrial grade silicone, and there was therefore no reason for their routine removal – now where have we heard that before? – both the French and German governments advised women to have them removed. Closer to home Australia’s medical watch dog agency, the Therapeutic Goods Administration (TGA) stated it would continue to investigate the situation over the coming months but did not believe there was enough evidence to warrant the removal of the implants. This despite the fact that round 8900 of the PIP implants had been used in Australian women, some of whom had complained about the devices splitting and leaking.
In New Zealand, the Ministry of Health said it had no record of any of the PIP breast implants being used, but whether they actually keep records of all breast implants used in New Zealand is far from clear.
Meanwhile, women with implants which include those recovering from breast cancer, report fearing that future ruptures could cause pain and inflammation as well as other problems resulting from the leakage of industrial silicone into their bodies.