Additional comments by
The human consequences
of regulatory failure
Independent Senator for South Australia
would like to acknowledge the many witnesses who provided information to the
committee of their own personal experiences with the PIP breast implant
devices. This evidence was vital to the committee’s understanding of the impact
this recall has had on people who were implanted with these devices, and I
thank these courageous individuals for their testimonies.
of the issues raised in this inquiry in relation to the Therapeutic Goods
Administration were also raised in the previous inquiry into medical devices,
undertaken by this committee. I am very concerned that there is a common thread
of serious problems in relation to approval and post-market monitoring of
devices, and communication of information to the public. While I acknowledge
that the TGA has been much more forthcoming in this case in comparison to the
withdrawal of the De Puy hip devices, I am concerned that evidence was provided
to the committee which still demonstrates significant systematic failures in
the TGA’s systems.
is very unfortunate that Medical Vision Australia refused to appear before the
committee, or to provide information in any way. Engagement with the committee
process would have shown a willingness on the part of MVA to be involved in
discussing the failures of regulatory systems in Australia and overseas, and
how they can be addressed. I also believe MVA’s participation would have been
meaningful for the individuals who have been affected by these implants.
am also concerned about MVA’s refusal to participate in the inquiry in light of
the company’s restructure last year. According to records from ASIC, in
December 2011 the company appeared to separate its cosmetic arm from its other
operations, forming two separate companies (Medical Vision Australia Cardiology
& Thoracic Pty Ltd, and Medical Vision Australia Plastic &
Cosmetic Pty Ltd).
It would have been very useful for MVA to state on the record the reasons for
this split, and the impact this split may have on individuals seeking legal
redress, including whether it would make it more difficult for victims of the
product MVA sponsored to seek compensation.
is also important to note that the lack of a properly operating breast implant
device registry added to the difficulties faced by the TGA and other bodies in
collecting information on the PIP device. The new ‘opt-out’ registry discussed
by Associate Professor Rodney Cooter, President of the Australian Society of
should be strongly and immediately supported by the Government, as the previous
inquiry into medical devices demonstrated the importance of a comprehensive,
properly operating registry.
arrangements in relation to the Special Access Scheme and informed consent are
very concerning, and indeed appear woeful. While it evident that such a scheme
should be in place to assist seriously ill patients who require specialist
products, it is hard to see how the SAS would be relevant for breast implant
devices, when there are already many approved devices to choose from. I support
the committee’s recommendation in this matter.
TGA’s lack of follow-up in relation to the provision of annual reports by
sponsors of Class III medical devices, as required by the standard condition
placed on sponsors when devices are listed on the Australian Register of
Therapeutic Goods, is unacceptable. While I acknowledge that a follow-up system
was established in 2011 and is now in place, it is vital that the TGA collect
and analyse all missing information to ensure that there is no risk to
Australian health consumers. This example also points to a lax attitude towards
post-market monitoring within the TGA, which was also apparent during the
previous inquiry into medical devices. While I note that the TGA has
acknowledged this and is taking steps to create a more positive, pro-active
stance, it does raise the question of how many problems we will be facing in
the future because action was not taken in the past. I strongly endorse the
committee’s recommendation regarding this issue.
note the committee’s comments in relation to the fact that either the TGA or
the sponsor of a device can take action in response to issues with a device. In
response to the committee’s report on the inquiry into medical devices, I
raised concerns about the use of ‘voluntary withdrawals’ as opposed to recalls.
It hints at a potentially conflicted relationship between the TGA and the
sponsor. The Hon. Dr Michael Armitage, of the Australian Health Insurance
Association, provided evidence to that committee in relation to the importance
of recalls as a type of sanction for companies.
A voluntary withdrawal obviously does not have the same impact.
Recommendation: That an independent review of the TGA’s processes relating to
device withdrawals and recalls be conducted within the next 12 months, with a
view to strengthening the TGA’s position as an independent regulator
previous committee inquiry also made several recommendations in relation to
adverse event reporting, as noted in the committee’s report. The Government has
yet to respond to these recommendations. It is my position that the PIP breast
implant device recall, and the issues surrounding it, emphasise the urgent need
for reform in this area.
is extremely concerning that evidence provided to the committee showed serious
flaws in the TGA’s original approval of the PIP devices. Presumably the
processes relating to the clinical evaluator and the Medical Devices Evaluation
Committee (as it was at the time) exist so that devices are only listed when
the appropriate conditions and safeguards are in place. It is incomprehensible
that the TGA would not follow the recommendations made by its own advisory
committee (MDEC) in relation to comprehensive annual reports from the sponsor.
It seems very unlikely that this expert committee, specifically set up to
provide “independent medical and scientific advice to the Minister and the Therapeutic
Goods Administration (TGA) on the safety, quality and performance of medical
devices supplied in Australia including issues relating to premarket conformity
assessment and post market monitoring”
would make these recommendations without reason. I believe the committee ought
to have gone further and emphasised that this recommendation was not followed
seems to indicate a 'low risk' attitude towards breast implant devices which is
unacceptable given their Class III rating.
fact that the approval for the device rested on the “arguments for essential
when there was limited clinical data is also very concerning. Recommendation 4
from the committee’s previous inquiry into medical devices was a specific
response to very real concerns that an increased number of very similar devices
on the market do not necessarily equal better health outcomes. In fact,
thanks to the comprehensive data collected by the National Joint Replacement
Registry, we know that many of the hip and knee prosthetic devices approved for
use in Australia perform “worse, or no better than, those that are currently
This fact refutes the very idea that a device should be approved on the grounds
that it is ‘essentially similar’ to another device.
circumstances raise particular concerns, especially when compared to the
example of the Food and Drug Administration (FDA) in the US for a similar time
period. As addressed in the committee’s report, Dr Daniel Fleming of the
Australasian College of Cosmetic Surgery provided evidence that, between 1992
and 2006, the FDA did not approve any silicone implants, and currently has only
approved three brands. According to Dr Fleming, this is due to the FDA’s
requirement in relation to long-term pre-market approval studies.
is also important to note that it is on the public record that surgeons were
notifying the TGA of problems with these implants. In particular, Dr Tim
Cooper, a plastic surgeon from Western Australia, stated on the ABC’s Background
Briefing program that he had written to the TGA with his concerns about the
high failure rate of the device.
He was informed by the TGA that no further action would be taken at that time,
and that they would continue to monitor the situation. This was
clearly an unsatisfactory response. Dr Cooper, and others like him, should be
applauded for their efforts to encourage action on the part of the TGA in
relation to these devices.
committee also received evidence that some individuals with PIP implants were
not contacted by their surgeons and, as a result, these individuals only became
aware of problems with their devices through the media. This is totally
unacceptable but, unfortunately, is consistent with evidence provided to the
previous inquiry on medical devices.
I support the committee’s recommendation in relation to this, as well as the
committee’s advice that the TGA provide medical practitioners with written
guidelines to outline their responsibilities in these situations.
also support the committee’s comments in relation to the TGA’s reliance on
their website as the primary form of communication with the public. An average
health consumer cannot be expected to constantly check the website just in case
the device they have been implanted with has been recalled. While I encourage
the TGA’s efforts to provide information and updates through their website, it
is clear that a more comprehensive alert system is needed, particularly given
the fact that surgeons do not (or cannot) always make contact with their patients
to pass on information.
issue of the type of information provided by the TGA also needs to be
addressed. I commend the TGA for their increased efforts at transparency and
public awareness, especially compared to their activities in relation to the De
Puy hip devices. However, it is important that the TGA also provides the public
with details of what further information they are seeking, what further testing
they are undertaking, and so on. This will help to reassure health consumers
that the TGA takes these types of issues seriously, and is acting accordingly.
I support the committee’s recommendation in relation to this.
example of the TGA’s poor communication is the response to a question on notice
I received from the TGA in relation to the gel contained in PIP implants
available in Australia. I asked whether the gel in the implants was in fact the
same gel that was originally approved, and the TGA’s response was that the gel
“conform[ed] to the relevant international standards for this type of product”
and that the samples tested had “superior physical properties to the approved
In response to another question on notice as part of this inquiry, the TGA
finally provided a more satisfactory answer, which explained the issues with
testing and detailed the TGA’s methods and knowledge. While I
acknowledge the TGA may not have had as much information when it answered my
original question in October 2010, an open and straightforward answer about
what the TGA knew so far and what they were intending to find out would have
been welcomed. This type of open communication is also much more helpful to
health consumers, as opposed to answers that appear to be constructed
specifically to hide something, even if this is not the intention. I strongly
agree with evidence provided by Ms Karen Carey of the Consumers Health Forum,
“Had the TGA been more
active, mainstream and honest about what information it had and did not have, I
think those expectations [of health consumers] would have been moderated.”
TGA’s delay in finding examples of explanted PIP devices to examine is also
concerning. The current testing regime, where devices can be tested by the TGA,
the manufacturer or other parties, appears to disadvantage the TGA as it may
not have had the opportunity to examine an explanted device before a recall or
withdrawal. If this system had operated more effectively, the TGA would have
been able to carry out tests on explanted devices already in their possession,
rather than facing a delay while devices were procured.
strongly support the committee’s comments in relation to DOHA’s assertion that
“there will always be under-reporting” in relation to medical devices. As the
committee asserts, the National Joint Replacement Registry, operated by the
Australian Orthopaedic Association, has an excellent history of data
collection. Evidence from the NJRR was instrumental in the committee’s previous
inquiry into medical devices, and this registry should be considered as the
benchmark in Australia. I also support the committee’s recommendation in
relation to this, although I believe it would be appropriate to aim for
comprehensive registries for all implantable medical devices in Australia.
Recommendation: That an independent inquiry be undertaken into the feasibility
of establishing comprehensive registries for all implantable medical devices in
endorse the committee’s comments in relation to the TGA’s national hotline.
While such a service could have been invaluable, the committee received
evidence from heath consumers that the hotline did not provide them with the
information and support they needed. The TGA should conduct an internal review
into the operation of the hotline so that such a service can be offered more
effectively in the future.
Recommendation: That the TGA conduct or commission a review into the operation
of its National Hotline, with a view to improving the service in the future
share the committee’s concerns about the lack of Government action in
implementing recommendations 13, 14 and 15 from the Review of the Health
Technology Assessment, and I strongly support the committee’s recommendation in
relation to this. The PIP implant recall,
coupled with the issues raised in this committee’s previous inquiry into
medical devices, point at serious flaws in the system. Recommendations 13, 14
and 15 of the HTA would go some way towards ensuring that Australian health
consumers do not face another serious failure on the part of the regulator.
is also concerning that some evidence provided to the committee seemed to
indicate a ‘commoditisation’ of healthcare in relation to cosmetic surgery.
Professor Rod Cooter, President of the Australian Society of Plastic Surgeons,
stated that many of the PIP implants were inserted by cosmetic surgeons, who
are unlikely to be credentialled at major public hospitals. According to
Professor Cooter, this then creates problems if “things go wrong”, as patients
end up in the public system and are taken on as patients by specialist surgeons
who are credentialled to work in public hospitals. On the
other hand, Dr Daniel Fleming of the Australasian College of Cosmetic Surgery
pointed out that as there is no specialty of cosmetic surgery, qualifications
in this area are not given the same weight as qualifications in plastic surgery
or other specialties.
Many health consumers would not be aware of these factors and, given the
increase in popularity of cosmetic surgery procedures, it would be appropriate
for guidelines or regulations to be developed in relation to disclosure to
patients. This would ensure that patients knew exactly what type of care their
practitioner could provide and where this care would take place, and prevent
the establishment of ‘one stop shops’ for cosmetic surgery procedures.
Recommendation: That the Department, in conjunction with relevant industry
groups, establish regulations for patient disclosure relating to the specific
qualifications of and services provided by their surgeon
issue of compulsory insurance for sponsors of medical devices was also raised
during the hearing, with the TGA stating that there is currently no requirement
for sponsors to have medical indemnity insurance. However,
the representatives of the Consumers Health Forum pointed out that in the past,
the Government has become the default insurer for adverse events, and that
requiring medical indemnity insurance would have a double benefit as insurers
would also seek to limit risks.
Given the fact that in this case, the manufacturer of the device is bankrupt
and the sponsor has restructured its company (although I note that MVA declined
to provide evidence in relation to the reasons behind their restructure),
compulsory insurance would have given individuals implanted with PIP devices
some peace of mind.
Recommendation: That all sponsors or manufacturers of medical devices listed on
the ARTG be required to hold medical indemnity insurance
is clear that there are many similarities between this case and the matters
raised during the previous inquiry into medical devices. In both cases, serious
systemic flaws have been highlighted and recommendations have been made to
address these. It is very disappointing that the Government has not yet
responded to the previous inquiry or taken steps towards implementing
recommendations 13, 14 and 15 of the HTA, which has been recommended in both
health consumers have been let down once again by systemic failures on the part
of the regulator. Evidence provided to the committee illustrated, once again,
serious flaws in the approval and post-market monitoring processes for medical
devices. Individual submitters also expressed their anger and disappointment at
the TGA’s level of communication with them and the public as a whole, and this
matter needs to be addressed as a matter of urgency.
two examples (PIP breast implants and De Puy hip prostheses) have illustrated
the serious problems, and with it the untold pain and suffering for thousands
of Australians, which could well have been avoided. While
the TGA and DOHA can make changes for the future processing and monitoring of
medical devices, we do not know what harm will still be caused by these past
and current bad practices. Ultimately, Australians should not have to pay for the
regulator’s failures with their own health.
Recommendation: That the Government implement the recommendations of this
inquiry and the previous inquiry into medical devices as a matter of urgency
Senator for South Australia
Senator Xenophon additional
Securities and Investments Commission, ASIC Historical Company Extracts, 24
2: Therapeutic Goods
Administration, answer to question on notice, Budget Estimates June 2010,
received 11 October 2010
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