The PIP scandal and medical device regulation

The European Commission (EC) is taking pro-active steps towards reforming the controls on medical devices to prevent a repeat of the PIP implant scandal, but what about Australia’s regulator?

The EC is proposing new policies to ‘address both the assessment of a device’s safety ahead of approval, as well as continued surveillance post-launch’. The article also states that the EC is looking to:

1. Give independent assessors stronger supervisory roles;

2. Provide independent assessors with greater powers and obligations to fulfil their supervisory role; and

3. Put in place new procedures to trace used medical devices to ensure a faster response to any problems.  

Additionally, since the PIP breast implant scandal was made public, the United Kingdom’s equivalent of the Australian Therapeutic Goods Administration (TGA), the National Health Service (NHS), has formulated an expert group that has released two reports regarding the PIP breast implants and contributed to a review into the actions of the UK regulatory bodies. 

Surgeons in the UK are also taking a proactive approach by undertaking studies into their experiences with PIP implants in order to gauge the degree to which these implants are failing. For example, Dr Awaf Quaba, a renowned plastic surgeon based in Edinburgh, has recently presented to the British Association of Aesthetic Plastic Surgeons the findings of his study relating to 300 women (600 implants) who received the PIP breast implants.  Dr Quaba reported an abnormally high rupture rate of over 35% over an average follow up period of more than seven years.  

To date, there has been few formal publications released by Australian surgeons regarding their experiences with PIP implants. 

The advancements being made in Europe stand in contrast to those in Australia. The latest report from the TGA dates back to mid-September, indicating they are still only reviewing the final report from the NHS expert group released over four months ago.  

We can only hope that the Australian regulatory authorities are encouraged by their European counterparts to take initiative and propose a new regulatory system which does not permit substandard products to be supplied to Australian patients. 

The need for reform appears to be urgent given the current scrutiny the TGA is facing over the approval of Johnson & Johnson vaginal mesh on the Australian Register of Therapeutic Goods. This is the latest example of a TGA approved medical device becoming the subject of a class action claim.

Discussion of Dr Quaba’s findings

The latest release from the TGA

For more information about PIP implants legal action contact Olla or partner Tim White on (08) 8212 1077.