In previous Healthfiles articles we have discussed the alleged defects in the DePuy Orthopaedics metal on metal hip replacements and the silicone breast implants manufactured by Poly Implant Prosthese (PIP).
The devices in question remain topical. The hip replacements are the subject of a class action in the Federal Court in Sydney, with NSW based Maurice Blackburn managing principal Ben Slade estimating the value of the Australian damages claim at more than $200 million.
The state of play with respect to the PIP breast implants is less clear. The TGA continues investigation and testing, but testing to date has not identified toxic or irritant chemicals in either the shell of the implant nor the gel. Tests on the strength of the shell and the consistency of the gel have apparently met relevant standards. In the words of the Chief Medical Officer “So far, scientific tests have identified some differences between the PIP breast implants and other brands of silicone breast implants, but these differences are small and do not indicate that there is an increased safety risk associated with PIP implants.” 1
At least two plaintiff law firms are still contemplating class actions in relation to the PIP breast implants and lawyers from at least one firm have travelled to Europe to seek further information.
The actual and potential class actions have also given rise to legal issues even for parties unlikely to be directly involved. Where patients with PIP implants have chosen to have them removed, they have requested that they be either returned to them or delivered to a laboratory for forensic testing. Many hospitals as a general policy discourage the return of explanted prosthetic devices to patients given possible infectious disease risk (particularly in the case of a silicone implant, which cannot be heat-sterilised). Such material might also be routinely categorised as “medical waste”, and therefore subject to (in Queensland) the restrictions contained in the Environmental Protection (Waste Management) Regulation 2000.
This approach taken to such requests will potentially bring a hospital into conflict with a patient who wishes to obtain their implants in order to investigate legal proceedings. While the issue does not appear to have been specifically considered, where patients have paid for their implants, on general principles the implants would be considered to be their property. Given the potential value of the implants as evidence, it seems likely that a court would have little difficulty confirming this position, and the use of the implants as evidence may well take them outside the definition of ‘waste’ in the Queensland Regulations.
Hospitals should however still consider the possible risks arising from the release of the material and be sure that consent and waiver forms properly reflect the potential risks involved in handling the material and the patients acceptance of those risks.
1 A recent English review however indicated that the implants were between two and six times more likely to rupture than other brands (although it also concluded that the substances contained in the implants were not toxic) and a report published today states that new figures show a dramatic rise in recorded ruptures between January and September this year.
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