Thanks to the well publicised issues with the De Puy Orthopaedics hip replacement and the breast implants manufactured by Poly Implant Prosthese (PIP), prosthetic medical devices have had a much higher profile in recent months than their manufacturers would prefer.

The problems with both devices are well known. As of 9 March 2012, the Australian Therapeutic Goods Administration (TGA) had received 171 confirmed reports regarding ruptures of PIP implants which may have been manufactured with industrial rather than medical grade silicone. Medicare rebates for MRI scans have now been offered to women with the implants in place. The De Puy hip replacements have been subject to a recall, and are the subject of at least two Australian class actions.

Discussion is now turning to what might be done to avoid further similar incidents. As noted in the most recent issue of the Medical Journal of Australia, the TGA has the challenging task of overseeing an industry with annual Australian revenue of $7.6 billion and balancing the requirement to balance device safety against allowing the Australian public timely access to potentially beneficial devices.

An analysis of the publicly available data on the TGA website noted increasingly frequent reporting of incidents involving medical devices. However, most reports were either not investigated or no further action was taken1. The authors felt that it was difficult to make informed decisions about the safety of any particular device based upon the publicly available data from the TGA.

Commentators have noted the different approaches taken to the hip implants and the breast implants. The hip implants were subject to the operation of the Australian Orthopaedic Association National Joint Replacement Registry (NJRR), which operates on an 'opt-out' basis and provided relatively comprehensive data which assisted in successfully identifying a higher than anticipated failure rate in the implants. Australia was the first country in the world to take regulatory action to ensure the removal of the devices from the market.

This outcome has been unfavourably contrasted with the operation of the Breast Implant Registry (BIR). The potential issues with the PIP breast implants were first identified by the French regulatory authority. Concerns included the possibility of increased rupture rates. However, the TGA had insufficient information to determine true rupture rates in Australia. Calculations by Dr Amy Jeeves and Dr Rodney Cooter2 suggest that only 3.4% of the relevant implants had been captured in the BIR, which operates on an opt-in system and involves no incentives (and in effect some disincentives) for patients and doctors to participate.

Dr Jeeves and Dr Cooter note that a comprehensive registry systems offer advantages in addition to identification of developing problems, including the ability to contact patients potentially affected by a faulty device and identification of exactly what device is present in cases where revision surgery is required (even if the device is not faulty). They advocate for the establishment of a new and more comprehensive Australian Breast Device registry.

The current focus on the safety of medical devices is likely to ultimately see both more comprehensive data on the TGA website and improved registry systems for high risk devices. The legal implications remain to be seen, but assuming a more comprehensive reporting system is adopted, doctors' duty of care would likely extend to ensuring that relevant information is included in the register (although it would be only in fairly unusual circumstances that a failure to do this could result in harm to the patient and therefore legal liability). A more comprehensive data set may also prove a valuable resource for solicitors investigating possible actions for plaintiffs regarding the failure of medical devices.

Footnotes

1 Jonathan Craig et al, Medical device regulation in Australia: safe and effective MJA 196(4) 256 - 259
2 Amy Jeeves and Rodney Cooter, Transforming Australia's Breast Implant Registry MJA 196(4) 232 - 234

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