Chapter 3
Recall of PIP breast implants – TGA monitoring and withdrawal of medical
devices
Actions undertaken for the Australian recall of PIP breast implants
3.1
Breast implants manufactured by PIP of France were recalled on 6 April
2010. The committee received evidence that, in relation to PIP breast implants,
the recall was performed:
...as a voluntary recall by Medical Vision Australia in
accordance with the procedures set out in the URPTG [Uniform Recall Procedure
for Therapeutic Goods].[1]
3.2
Upon receiving advice from the French regulator, AFSSAPS[2] on 31 March
2010 through a National Competent Authority Report (NCAR), the TGA
worked with Medical Vision Australia to recall this device from the
market.[3]
The submission from the DoHA explained the interaction between the regulator
and the sponsor between 31 March and 6 April 2010 as follows:
Later on the same day (31 March 2010), the TGA was contacted
by a regulatory consultant acting for Medical Vision Australia. The consultant
confirmed the AFSSAPS report of 31 March 2010.
On 1 April 2010, in accordance with standard procedures as
set out in the URPTG, the TGA wrote to Medical Vision Australia requesting
confirmation that they had imported and distributed PIP implants in Australia
and details of that distribution.
On 3 April 2010 the TGA received confirmation via the
sponsor’s agent that Medical Vision Australia had already ceased importation
and supply of PIP implants, had contacted medical practitioners to whom they
had supplied stock requesting that the stock be returned, and had advised
implanting surgeons to not implant any unused PIP implants.
On 6 April 2010, a notice was posted on the TGA website advising that Medical Vision Australia (following
consultation with the TGA) was undertaking the recall of all non-implanted
silicone gel breast implants manufactured by PIP. The notice advised that the
product was being recalled following concerns expressed by AFSSAPS that there
may be an increased incidence of ruptures with this product that it was
urgently investigating the product and reports of its failure, and that further
information would be provided on the TGA website. The notice also advised any
consumer who was concerned about their implant to contact their treating breast
implant physician for advice and follow up.[4]
3.3
The TGA issued the recall alert to consumers on their website on 6 April
2010. This alert included the following advice:
Medical Visions Australia Pty Ltd following consultation with
the Therapeutic Goods Administration is undertaking the recall of all
non implanted silicone gel breast implants manufactured by Poly
Implant Prothèse (PIP). The recall applies to all models of this type of
implant.
The product is being recalled following concerns by the
French medical device regulatory authority (AFSSAPS) that there may be an
increased incidence of ruptures with this product. The TGA is urgently
investigating the product and reports of its failure. The TGA will provide
further information on this website.
Consumers with these silicone gel implants who have concerns
should contact their treating breast implant physician for advice and
follow-up.[5]
3.4
Following this formal recall by Medical Vision Australia, the TGA
advised the committee the following actions were undertaken:
...the TGA sent a copy of the recall notice to the
Australasian College of Cosmetic Surgery (ACCS) and the Australian Society of
Plastic Surgeons (ASPS). Reference
to the TGA alert was posted to their respective websites on 7 April 2010.
On 7 April 2010, the TGA requested Medical Vision Australia
to send a “Product Notification” to all surgeons who may have purchased the
product. The wording of the formal letter and the product notification were
agreed by the TGA and were despatched by Medical Vision Australia on 8 April
2010.[6]
3.5
The TGA explained to the committee that their powers are limited in
relation to requiring consumers to have implants removed. As explained in
DoHA's submission to the committee:
...when an implantable medical device is recalled, TGA’s
regulatory powers do not extend to requiring patients or recipients of such
devices to have them surgically removed. Rather, where relevant, the TGA
provides general advice to doctors and patients about the appropriate
monitoring of such devices so that clinical management can be individualised to
the circumstances of any patient who has such a device.[7]
3.6
The TGA cancelled PIP breast implants from the ARTG on 14 April 2010 at
the request of Medical Vision Australia.[8]
Government action after the recall of PIP breast implants
Response time from the Government
regarding the device recall
3.7
Over the course of the inquiry, concerns were raised with the committee
about the length of time taken between the recall in April 2010 and the public
response by the TGA in 2012 when media reports aired regarding this issue. As
one submitter reflected:
...I have questioned why I hadn’t been informed of the
problem long before Sixty Minutes went to air. I was told by my surgeon that
they had computer problems and had not been able to contact every one of their
patients and that others had complained of the same. I find this a very poor
explanation from all involved when my contact details have always been the same
and two years have passed since the medical industry were informed of the
product recall.[9]
3.8
As indicated in Chapter 2, the TGA did issue an alert for consumers
about the product recall on 6 April 2010. Given the evidence received it is
clear that the alert was not effective in reaching consumers.
3.9
The committee received evidence that the TGA does not have the authority
to record patient information and contact them directly.[10]
As such, it appears the most common form of communication from the TGA to
consumers is via their website. The TGA has provided updated advice and
information since April 2010, however there is an increase in frequency of
these updates from December 2011.[11]
3.10
The TGA issued four updates throughout the year in 2010, and two in 2011
on PIP breast implants. In 2011, the first update was on 27 January and the
second update was on 27 December.[12]
3.11
The TGA explained to the Committee that their level of engagement and
follow up with French authorities within this timeframe was frequent:
Between April 2010 and January 2011, the TGA had on a number
of occasions sought additional advice from the French authorities regarding the
results of their testing. It is the usual practice internationally that
regulators share results of testing that are done. So, generally, if we have
done testing we share that with all other interested regulators. We tried to
get information on the actual findings. The French said, 'We're concerned about
our rupture rate.' We said, 'What is your rupture rate? We are concerned about
the tensile strength. Can you show us the results?' We were unable to get those
results. In December 2011, the French government announced a policy change
based on no new information that was available to the TGA that it would
recommend the non-urgent precautionary removal of these implants based on some
of these additional findings. We again
sought information from the French authorities about those findings. It was not
forthcoming, and so we did some further testing. Because we could not get the
results of the rabbit irritation tests, we repeated those in a laboratory in
Australia and we repeated them also in the same laboratory in France that had
done them for the French authorities but could not tell us what the results
were because that was commercial-in-confidence between the lab and the French
authorities.[13]
3.12
The seriousness of PIP breast implant issues prompted the policy shift
by the French authorities in early December 2011, following a report in France
of the death a woman from anaplastic large cell lymphoma (ALCL), a rare form of
cancer of the immune system. Following issuing information about this possible
link early in December, this was later withdrawn. The French Health Ministry then
released a press statement on 23 December 2011indicating there is "no
increased risk of cancer in women who have PIP implants compared to other
implants".[14]
3.13
The committee sought clarification from the French regulator regarding
this correction; however at the time of publication of this report no response
has been received.
3.14
The committee heard from several witnesses that a link between cancer and
PIP implants and is not supported by clinical evidence. The Chief Medical
Officer, Professor Baggoley reflected in his report on PIP breast implants:
There is no evidence that the risk of ALCL in the breast for
PIP breast implants is greater than for all silicone gel filled breast
implants. No cases of ALCL in the breast in women with PIP breast implants have
been reported in Australia.[15]
3.15
Following the developments in France in December 2011, the TGA commenced
frequent updates for consumers and medical practitioners on their website in
January 2012. A hotline service for individuals concerned about PIP implants
was set up in January 2012 and this is discussed further in Chapter 4.
3.16
The Consumers Health Forum Australia (CHFA) stated in their submission
to the committee that the TGA acted with "reasonable timeliness to respond
and provide information to consumers and health professionals about safety
risks and treatment options"[16]
and they particularly valued the measured advice provided by the Government and
the:
Publication of regular updates as further evidence emerged on
risks associated with the implants
Publication of information specific to the Australian
context, including information on the number of PIP implants used in Australia
and the number of rupture reports for these implants received by the TGA, the
TGA’s activities in testing the implants, the availability of these implants in
Australia, and the absence of any reports of Anaplastic Large Cell Lymphoma in
Australian women who had received PIP implants
Provision of specific, separate information for consumers and
health professionals
Inclusion of information on reporting adverse events in some
communications about PIP implants.[17]
3.17
However, the CHFA also stated the communication with the public could
have been improved by the TGA publishing what information is
"unknown" in order to be more transparent.[18]
This was explained further at the hearing by Ms Karen Carey from the CHFA:
When consumers think that performance is substandard, quite
often it is because of an unrealistic expectation, and that unrealistic
expectation can only be dealt with through information. An opportunity missed
in this situation was to demonstrate that the TGA, out of all the governments
in the world, actually took the most active position; however, if you are a
consumer, have that implant in and need to know if you need to have the
operation now, your expectations were not met.
...
Had the TGA been more active, mainstream and honest about
what information it had and did not have, I think those expectations would have
been moderated.[19]
Committee View
3.18
The committee acknowledges the recent frequency of information provided
by the Therapeutic Goods Administration on their website through safety alerts,
background and updated advice. However, the committee is concerned about the
time lag between the initial device recall in April 2010 and when the TGA
commenced issuing this regular advice late in 2011.
3.19
The committee is also concerned about the TGA’s focus on their website
as the primary form of communication. While this is certainly appropriate for
providing updates to individuals who are already engaged in an issue, relying
on this to reach individuals who are not yet aware that they should be
monitoring the website is clearly ineffective. The TGA needs to implement a
comprehensive alert strategy for all future recalls so that affected individuals
are aware of the situation and know to visit the website for further
information. This strategy should utilise all options available through federal
and state government communication portals to maximise the chances of the
alerts reaching those affected. The committee is also of the view that when a
health issue of considerable public concern occurs, Ministers and the top
levels of federal and state governments have a role in providing leadership and
coordination to ensure that information is disseminated quickly and
effectively.
3.20
The committee is of the view that frequent advice on PIP breast implants
could have been issued from April 2010 onwards. This advice could have been
strengthened by including information regarding the interaction between the TGA
and French authorities as well as updates on other information the TGA was
seeking and tests that were being performed. The committee strongly encourages
the TGA to consider this approach on device recalls in the future.
Recommendation 5
3.21
The committee recommends that the Therapeutic Goods Administration
include in their updates on PIP breast implants, and as part of any future
recalls on other devices or medications, details of the type of evidence they
are pursuing in order to further inform the Australian public.
Engagement with international
regulators
3.22
The committee received evidence about the TGA taking a lead role in
convening international regulators to encourage information sharing regarding
PIP breast implants. The TGA stated it had increased its "efforts to
obtain as much information as possible from its international regulatory
counterparts in the UK, the European Commission, the USA, Canada, Brazil,
Japan, Switzerland and Singapore regarding PIP implants"[20]
and convened an international laboratory testing group to share information on
testing results on PIP breast implants.[21]
3.23
This engagement with international regulators included the TGA convening
a teleconference with all major regulators on 11 January 2012 to promote
information sharing. Although invited, the French regulator did not participate
in this meeting.[22]
3.24
The committee heard from the Department that despite several efforts to
obtain information from the French regulator, the Department only received the
results from the AFSSAPS chemical, mechanical and biological testing on 7 March
2012. This information was obtained following request through the diplomatic
post on 11 January 2012.[23]
3.25
At the hearing, the TGA acting National Manager, Dr Richards explained
that:
...the European Commission has asked that scientific expert
committee to reconvene and update that report and has invited the head of TGA's
laboratories to participate in that committee in recognition of the leadership
the TGA has shown internationally in the provision of scientific evidence.[24]
Committee view
3.26
The committee commends the TGA for its engagement with international
regulators to date.
Recommendation 6
3.27
The committee recommends that the TGA publish updates and details of the
discussions that have taken place with international regulators.
Establishment of advisory panels
3.28
The Australian Government convened two specialist advisory committees to
support improved information and advice on PIP breast implants:
-
The TGA convened an expert advisory panel to review the evidence
in relation to the safety of PIP breast implants. This panel comprised
clinical, scientific and epidemiological experts from TGA statutory medicine
and medical device safety committees, along with additional surgical experts
from the Royal Australasian College of Surgeons, the Australian Society of
Plastic Surgeons and the Australasian College of Cosmetic Surgeons.[25]
-
The CMO established a Clinical Advisory Committee on 9 January
2012 to provide regular and frequent advice on clinical measures, risks and
benefits, and communication strategies in response to health concerns related
to PIP breast implants. The committee includes senior representatives of
relevant clinical and consumer groups.[26]
3.29
Representatives from the Australian Society of Plastic Surgeons (ASPS)
and the Australasian College of Cosmetic Surgeons (ACCS) were on both advisory
panels. During the inquiry, the committee received evidence from several
submitters regarding the potential conflict of interest in having medical
professionals that used PIP breast implants in their surgeries advising the
Australian Government issues regarding this medical device. An example of these
concerns is expressed below:
I also find the fact that they are using
Dr Fleming as one of their main advisors on the issue very concerning as he is
apparently one of the largest PIP implanters, if not the largest, in the
whole country.[27]
3.30
Dr Daniel Fleming, representative from the ACCS, acknowledged the
perceived conflict of interest and advised the committee:
Any surgeon who has implanted PIP breast implants could have,
or could be perceived to have a conflict of interest in giving advice about
them.
...
In fact I am neither biased for or against PIP and Medical
Vision Australia in the advice I have given to the TGA and CMO Committees. The
minutes of the meetings show that all of the advice I have given has been
evidenced based or given in order to get more evidence.
...
Nevertheless, the possibility of conflict of interest, or
perceived conflict of interest does exist and has been addressed. My experience
using PIP implants and my dealings with Medical Vision Australia were disclosed
in writing by me to the chairmen of the committees.[28]
3.31
The committee also received evidence from CHFA that having expertise on
advisory panels are key to accurate information and this is appropriate if
conflicts of interests are managed appropriately. As Ms Carey from the CHFA
explained:
...it is really important to have the surgeons who have
actually been implanting so they know about the device and to have the
radiologists who can give advice about what tests are appropriate. So I would
like to be able to say that sometimes conflicts of interest are necessary. On
that committee all of the measures to manage those conflicts were in place and
were exercised extremely well by the chair. I think everybody knew who had
conflicts. When you have all of the stakeholders there, even though some of
those stakeholders have conflicts, the debate on the committee allows the
effects of those conflicts to be minimised.[29]
Type of TGA testing of PIP breast implants after
the recall
3.32
The TGA requested PIP breast implants from the sponsor when the device
was recalled on 6 April 2010 and requested further samples on 6 May 2010.[30]
The TGA advised the committee that they were the first regulator to publish the
outcomes of testing conducted on PIP breast implants on 2 July 2010 and that
the French regulator announced their testing outcomes on 28 September 2010.[31]
Outcomes from the initial tests conducted by the TGA was that:
...the PIP breast implants supplied in Australia conform to
the relevant international standards for this type of product including those
for gel cytotoxicity and shell strength.[32]
3.33
The TGA test results were supplied to the UK regulator, MHRA and the
French regulator, AFSSAPS.[33]
3.34
Concerns with this initial testing were raised with the committee by
several submitters stating this outcome was based on limited testing. One
submitter explained that testing on non-implanted devices is limited as the TGA
had tested samples that were not:
...subjected to the same heat, conditions or environment as
which they would have been in the human body...To my research these three
products, if kept at a cooler temperature are of a high viscosity thus meaning
in the human body at temperature of 36.6 degrees Celsius, the viscosity of
these products is severely compromised...[34]
3.35
The frustration about the TGA testing was evident in the information
provided to the committee. Ms Telford, an Australian woman who had received PIP
breast implants, stated:
I am sick of hearing the TGA telling us that there is no
evidence and they need to be tested, and then them saying that they tested the
outer shell. I would like to know if they have actually tested a wide range of
these implants that have been explanted from woman. [T]ested the silicone, the
shell, test what happens when the industrial grade silicone contained in them
are put inside a warm, wet environment and see what happens.[35]
3.36
Dr Richards provided evidence to the committee that the TGA tests of the
viscosity of the gel have been "done in accordance with the international
standard, and, of the samples tested by the TGA, all of the gels tested met the
international standard for viscosity that applies to this type of device".[36]
3.37
The TGA continued to test PIP breast implants and in its submission to
the committee, the Department of Health and Ageing indicated the following
advice provided and action taken regarding this testing:
On 1 October 2010, the TGA reaffirmed (by way of a statement
on its website) its earlier (2 July 2010) advice that testing indicated PIP
implants met relevant safety and quality requirements and that patients with
concerns should consult their implanting physician.
This advice was provided to the relevant specialist colleges
in Australia (ASPS and ACCS) who had posted similar advice for patients on
their websites in April and July 2010. On 12 October 2010, Medical Vision
advised the TGA that, in accordance with the TGA’s normal requirements, all
recalled stock, which had not been provided to the TGA for testing, had been
destroyed. On 7 February 2011 the TGA held a teleconference with members of the
ASPS to update them on PIP implants.[37]
3.38
The CMO also provided the following explanation in his report on PIP
breast implants:
The TGA testing plan is using the broadest cross-section of
samples of PIP breast implants available to the TGA, and includes both PIP1 and
PIP 2 formulations of the filler gel. To date, samples of the product with an
expiry date before 2011 have not been available to the TGA.
The TGA has tested 19 different batches (29 samples) of PIP
breast implants available in Australia plus batches of other brands of breast
implant for comparison. The TGA has obtained a further five batches (23
samples) of PIP breast implants from overseas for the on-going testing program.
The TGA is investigating explanted PIP breast implants to
complement testing being carried out on unused sterile PIP breast implants and
to provide further evidence that will assist with determining the overall
quality and safety of the product.[38]
3.39
The legal firm Tindall Gask Bently (TGB) however indicated that the
testing was misdirected and focussed on ruptures rather than the silicone that
was contained in the implants. Mr Tim White from TGB stated:
...it is clear that one of the primary concerns from the
French authorities related to the use of unauthorised gel that had been
utilised in the PIP implants. By contrast, the majority of the statements from
the TGA have concentrated not on the use of unauthorised silicone but rather on
the rupture rates of the PIP implants.[39]
3.40
The TGA issued advice regarding the concerns raised by the French
regulator, AFSSAPS, and the results from TGA testing, on their website and issued
the following advice in their update on 23 March 2012:
The French regulatory authority, AFSSAPS, has reported that
the authorised and unauthorised silicone gels have different ingredients which
can result in differences in the physical and chemical properties of the gel.
In particular, AFSSAPS noted that some batches of unauthorised gels contained
higher amounts of small silicone molecules (called low molecular weight
siloxanes) than the authorised gel. The results of the TGA testing for
these small silicone molecules confirms the results obtained by the French
authorities, but the presence of these chemicals (which are widely used in
cosmetics) is not considered a health risk.[40]
3.41
The committee also received evidence from the CHFA that the need to
conduct tests on explanted PIP breast implants is vital to provide accurate
advice:
I think in this instance there was a delay for the TGA to get
the ex-planted devices in order to examine them. Examining items off the shelf
can tell you about whether or not they conform with the specifications for the
device, but getting an ex-planted device can tell you something really
different. It can tell you whether the problem device conforms to those
specifications, but it can also tell you whether the act of implanting that
device into somebody changes the performance of the device. It is absolutely
crucial, and I think the TGA need to be more active and faster in obtaining
ex-planted devices.[41]
3.42
The committee also received evidence from Associate Professor Cooter of
the Australian Society of Plastic Surgeons that surgeons usually sent
explanted, faulty devices back to the manufacturer through the supplier, who
would then be responsible for alerting the TGA.[42]
This situation raised a significant issue in relation to a potential conflict
of interest, where the party with the greatest financial stake (the
manufacturer) is responsible for reporting faults with their own product. It
also meant that the TGA may not have ready access to explanted devices for
testing. Associate Professor also advised the committee that this issue of how
surgeons should communicate their clinical explants information to the TGA has
since been clarified[43]
but did not expand on the nature of this clarification.
Committee view
3.43
The committee notes that in relation to PIP breast implants, the
Therapeutic Goods Administration is continuing its testing on removed implants
and is gathering data through following up adverse events reports. The
committee believes the TGA needs to undertake appropriate testing, particularly
on explanted devices, and publicly release these results as a priority. Advice
issued by the TGA on test results should be supported by the Chief Medical
Officer.
Recommendation 7
3.44
The committee recommends that the TGA review its processes to ensure that
faulty explanted devices are available to the TGA for independent testing.
Data collection – adverse event monitoring
3.45
Under the Australian Regulatory Guidelines for Medical Devices,
manufacturers and sponsors must inform the TGA of all reportable adverse
events, within the appropriate timeframes. They must also ensure timely and
appropriate action is taken. However, the TGA also encourages the reporting of
adverse events by users of devices to monitor the performance of medical
devices in Australia.[44]
3.46
As at 18 May 2012, the TGA had received 284 reports of confirmed
ruptures and 56 reports of unconfirmed ruptures of PIP breast implants.[45]
These reports were provided by surgeons, the supplier and patients. A report is
confirmed when there is sufficient information to uniquely identify the
patient, the implant used and that an X-Ray or other diagnostic image showed
that the implant was ruptured or the implant was found to be ruptured when it
was removed. An 'unconfirmed' report is where the TGA has sought additional
information but has not received "sufficient information to uniquely
identify the rupture".[46]
3.47
The TGA issued advice on 4 January 2012 that, based on the TGA's report
data, the rupture rates of PIP breast implants were 0.4% and "well within
the expected rupture rate for silicone breast implants".[47]
The committee received evidence that this figure may have been misleading. The
Australasian College of Cosmetic Surgery submission stated:
In its 4 January 2012 web update, the TGA reported that it
had received reports of ruptures of PIP implants equivalent to 0.4%. Although
true, this was likely to mislead patients and give them false reassurance as
the true rupture rate could not be deduced from the rates spontaneously
reported to the TGA. This was bound to be a very significant under-estimate.[48]
3.48
One submitter was critical of this evidence base:
The first indication I had of this was when the TGA initially
reported very low rupture rates of the PIP breast implants based on incomplete
and insufficient data from a voluntary reporting system. Yet the TGA used these
inaccurate rates as ‘evidence’ that PIP breast implant rupture rates were
similar to rupture rates of other breast implants.[49]
3.49
The Department of Health and Ageing explained in their submission to the
committee that when the device was recalled, the TGA:
...reviewed data it held in relation to ruptures of other
brands of silicone gel implants. These data indicated that the number of
ruptures of PIP implants, as reported to the TGA, did not exceed those that
would be expected based on published studies concerning implants generally.
Based on the information available to the TGA in the period
immediately after the recall of PIP implants, the TGA considered that the
initial reports from AFSSAPS of increased rupture rates of PIP gel implants
were not reflective of the Australian situation.
...
While the number of reported ruptures of PIP implants was
subject to the same spontaneous, voluntary reporting by users that applied to
other brands of silicone breast implants, TGA considered it reasonable to
compare the prevalence of reported ruptures with that reported for other
brands. However, once TGA stimulated the reporting of ruptures of PIP ruptures
by writing to surgeons in January 2012 asking for all such ruptures to be
reported, such comparisons ceased to be valid.
3.50
It is noted by DoHA in their submission that there are limitations to
this data. Notably, the voluntary basis of reporting to the TGA, and other
regulators, does not provide an accurate measure of actual adverse events as
"there will always be under-reporting".[50]
However, the committee notes the excellent performance of the National Joint
Replacement Registry, which collects information on approximately 99 percent of
relevant procedures in Australia[51]
and that information is provided to the Registry on a voluntary basis by
hospitals and medical practitioners. The committee is of the view that, with
the appropriate systems in place, under-reporting does not have to be accepted
as unavoidable.
3.51
Several submitters advised the committee they had reported an adverse
event to the TGA regarding their PIP breast implants, however indicated that
they had limited follow up from the TGA. As one woman explained :
I submitted an ‘adverse event to a medical device’ form to
the TGA in January 2012 yet, except for a standard email acknowledgement of
receipt, I was not asked for further details until April 2012, when I was sent
a letter requesting that the TGA contact my treating doctors for further
information of my symptoms. This delay is unacceptable, particularly when the
TGA were advised in the ‘adverse event to a medical device’ form that I was so
ill from the PIP breast implants, I had been hospitalised.[52]
3.52
The Australian Medical Association (AMA) stated in their submission that
those implantable devices "are likely to always have a failure rate"
and the TGA's role in post-market assessments such as adverse event monitoring
and timely responses to device recalls would be strengthened by the
introduction of implantable device registries.[53]
Committee view
3.53
The committee accepts that the TGA is now endeavouring to share
information as it becomes available, and has taken steps to ensure their advice
about the PIP breast implants is based on the current evidence it has available
to it.
Recommendation 8
3.54
The committee recommends that the TGA's advice about PIP breast implants
include the limitations of the evidence and data to ensure that consumers and
medical professionals alike are in receipt of as much information as possible
that will enable them to make informed decisions about any future treatment.
Recording keeping – the need for an opt-out breast
implant registry
3.55
The committee received evidence from witnesses which raised concerns about
the current record keeping practices regarding breast implants. Australia has a
breast implant registry; however the current arrangements only generate limited
data. The organisation currently responsible for maintaining the current breast
implant registry, the Australian Society of Plastic Surgeons (ASPS) explained
that the current Breast Implant Registry (BIR) in Australia has provided
limited information because of its voluntary nature and low capture rates.[54]
The current BIR is an opt-in arrangement and records are kept only when a
patient volunteers to be part of this registry. The submission from ASPS
explained:
Not only was the registry’s ‘opt-in’ design at fault but each
patient was levied a fee to be included in the BIR thereby compounding the
disincentives to participate.[55]
3.56
The ASPS further explained that the BIR has a low capture and of the
approximate 13 000 PIP breast implants sold in Australia, the current BIR
captured less than 4% of these.[56]
It could be argued that if this database was a comprehensive registry of
patients that had received PIP breast implants, it could have been drawn on to
advise consumers about the product recall.
3.57
Several submitters raised their concerns with the committee about the
lack of record keeping and limited notification of the recall. Many women were not
contacted and advised about the recall due to poor record keeping practices by
surgeons, or due to absence of a centralised database. As one submitter stated
in her submission:
...they have failed us by not having adequate record keeping
requirements in place, neither in the local surgeries or at a mandatory
centralised reporting agency so that if this does happen, individuals affected
can be informed as matter of course and make their own judgements with
appropriate medical advice as to the course of action from there.[57]
3.58
The value of clinical registries, particularly in light of the PIP
breast implant recall notification of recall and adverse event monitoring, is
widely accepted by stakeholders. The CMO provided evidence to the committee
regarding the value of registers in relation to identifying patients that have
medical devices.
The value of registers as safety and quality items that can
assist, at the very minimum, to identify patients who have implantable medical
devices is understood.
...
The best way of communicating with patients who have devices
is not of a general or indirect nature; it would be able to go to them directly
and say, 'We understand you have this device. There is now an issue. Please now
go and contact your doctor.' It is very straightforward.[58]
3.59
The AMA shared this view and stated in their submission to the committee
that clinical registries:
...allow medical practitioners and the TGA to respond
appropriately when there is a clear failure of a device that is beyond that of
like products. For example, a breast implant registry could have provided early
evidence of the failure rate of PIP breast implants compared to other breast
implants.
Clinical registries allow medical practitioners to identify
problems early, respond appropriately in a coordinated manner and support
clinical decisions about which devices are delivering the best patient outcomes
in particular clinical circumstances.[59]
3.60
The CHFA also provided evidence to the committee in support of a device
registry, stating that it should be based on an opt-out arrangement.
The international experience and Australian experience shows
that an opt-on register simply does not get user reliability of data and
therefore the data that you have is so biased as to be pretty useless. So if
you are going to have a register it has to be an opt-off.[60]
3.61
DoHA indicated that the opt-out approach is the preferred model and
explained:
The Australian Commission on Safety and Quality in Health
Care (ACSQHC) report Operating Principles and Technical Standards for Australian
Clinical Quality Registries (2008), identified two methods by which consent
can be obtained to participate in a clinical quality register:
1. Asking
individuals to register their willingness to be included (opt in); or
2. Presuming
that an individual will be willing to be included on a register unless they
lodge an objection (opt off or opt out).
The ACQSHC found that ‘it has been repeatedly demonstrated ...
that requiring specific permission in advance from potential research
participants (opt in) will lead to the collection of a relatively small
fraction of eligible cases and the resulting data will have no credibility for
quality improvement’.
The ACQSHC report recommended that the opt out consent should
be a standard approach taken upon the establishment of new registers.[61]
3.62
Internationally, the value of registries for collecting data was
recently reflected in the European Commission Scientific Committee on Emerging
and Newly Identified Health Risks report, 'The Safety of PIP Silicone Breast
Implants' released on 1 February 2012, This report recommended "a
reliable database on silicone breast implants be established."[62]
3.63
The ASPS has reviewed the design and capability of the current BIR and
compared this with the successful National Joint Replacement Registry (NJRR)
monitored by the Australian Orthopaedic Association (AOA). The NJRR was
explored in detail in the committee's 2011 report on the regulation of medical
devices.[63]
The NJRR design is an opt-out arrangement in which the patient automatically
goes on to the registry and their data is captured, unless they officially
object to this occurring.[64]
3.64
The committee is aware that the ASPS and the Monash University has
collaborated in developing a proposal for a new Breast Device Registry (BDR),
with the proposal including the TGA to provide expert input on the BDR
development.[65]
This redesign BDR which is an opt-out arrangement is at the pilot stage and is
being trialled at three independent hospitals.[66]
Committee view
3.65
In light of the PIP breast implants recall, the committee believes there
is a need for a thorough collection of data regarding breast implants and other
medical devices. The committee is of the view that an opt-out breast implants
registry would provide more accurate data regarding what type of implants
patients received, when and by what surgeon, that could be drawn on should a
similar device recall occur in the future. The committee also thinks that
other types of medical devices would benefit from similar registries.
Recommendation 9
3.66
The committee recommends that, in light of the Poly Implant Prothese
breast implant recall, the Department of Health and Ageing establish an opt-out
Breast Implant Registry as a priority. The design of such a registry should be
based on the National Joint Replacement Registry.
Medicare subsidy for MRI
3.67
In order to evaluate whether breast implants have ruptured and may need
removal, an MRI scan is required. As Associate Professor Cooter from the ASPS
explained:
[A] MRI is highly accurate in identifying ruptures with high
sensitivity and specificity. The imaging of choice for “standard” international
practice for assessment of breast implant integrity is MRI.[67]
3.68
The Australian Government announced on 10 March 2012, that from 12 March
2012, patients with PIP breast implants will have access to Medicare benefits
for one MRI scan to evaluate the integrity of their implants. This rebate is
available for 12 months until 12 March 2013.[68]
3.69
These Medicare rebates apply to the new PIP MRI items and the schedule
fee for the PIP MRI services has been set at $500 per item. The committee
received evidence at its hearing that women who have an MRI will be covered for
$426 out of the approximate cost of $500.[69]
However, it remains at the provider's discretion whether or not to bulk bill.
DoHA issued the following advice regarding this discretion:
There are bulk billing incentives for diagnostic imaging
services, including these new MRI services. Medical practitioners, including
radiologists, are free to set their own value on the services they provide.
While the Government is responsible for setting the schedule fee on which
Medicare benefits are based, there is nothing to prevent radiologists or any
other medical practitioner setting fees that exceed those in the schedule. In
these circumstances, you may be required to pay the gap between the fee charged
and the Medicare rebate.[70]
3.70
The committee also notes evidence provided by DoHA in relation to what
these Medicare arrangements do not cover:
Medicare arrangements do not cover the cost of prosthetics,
which in this case is the breast implant. The cost of these may be subsidised
by private health insurance, depending on the terms of the policy. PIP implants
were listed on the Prostheses List in August 2006, and were removed in August
2010 at the request of the sponsor and hence have not been subsidised by
private health insurance since then. However,
other breast prostheses remain on the Prostheses List and, subject to the
patient’s policy, will be subsidised by private health insurers when the
surgery is medically necessary or where the surgery is a service for which
Medicare benefits are payable. Hence, women who are undergoing medically
necessary implant removal and replacement can expect that private health
insurance benefits will be available.[71]
3.71
The importance of MRI scans is two-fold. The scans provide patients with
an accurate assessment of the integrity of their implants and the results of
these scans may also feed into data regarding rupture rates. As the ACCS stated
in their submission:
...the true rupture rate of PIP implants is not yet known.
This needs to be deduced from the results of the MRI scans currently being
performed on large numbers of women with PIP implants. Patients can then be
informed of the rupture rate and how it compares to the known rupture rate of
other brands of breast implants. This information will allow women to make
informed decisions about whether or not they wish to remove, replace or
continue to monitor their PIP implants.[72]
3.72
The committee notes that there are investigations being undertaken on
how best to audit the results of the MRIs being performed around Australia in
order to obtain a more accurate indication of the rupture rate of PIP Implants.[73]
3.73
On evidence received from individual women with PIP breast implants, the
committee understands the Medicare rebates for MRI scans are also welcomed,
however the 12 month period in which the Medicare rebate is available may not
be sufficient. Associate Professor Cooter, President of the ASPS, provided
evidence to the committee that ideal practice would include regular MRI
scanning of implants to assess whether a rupture has occurred.
Senator XENOPHON: There was an announcement several
months ago by the government to fund MRI scans, which you say are the gold
standard for determining whether there is a leak or a rupture. It is a one-off
scan until 12 March next year. Is a one-off scan sufficient or do you think it
would be prudent to offer that rebate or that assistance beyond a once-off and
that it should be done on an annual basis for the next two or three years? What
is a precautionary approach in respect of the number of MRI scans to determine
whether there is a problem with these implants?
Associate Prof. Cooter: At least every second year
would be ideal practice in my view. It comes back, however, to the use-by date
of implants. There is some mounting view that a 10-year time frame should
be put on this. Given that it is now over two years since the
last one went in, up to four MRIs would cover everyone...[74]
Committee view
3.74
The committee acknowledges the Australian Government's
announcement regarding Medicare items covering an MRI scan, and notes this
announcement came almost two years after the product recall. The committee is
of the view that the one-off nature of these scans and the 12 month time limit
on these rebates is too limited. The committee therefore strongly encourages
the Australian Government to extend these rebates in accordance with the
current medical advice.
Recommendation 10
3.75
The committee recommends that the Australian Government extend the Medicare
rebates for MRIs in accordance with the current medical advice.
Locations of MRI machines with a breast coil
3.76
In addition to the frequency of MRI scans, the issue of the location of
appropriate MRI machines (i.e. machines with a breast coil) to conduct the scan
to accurately evaluate the integrity of the breast implants was raised with the
committee. This is explored further in Chapter 4 of this report.
Establishment of National breast
implant hotline
3.77
The Australian Government also announced on 7 January 2012 the national
hotline for Australian patients concerned about their PIP breast implants to
contact and seek additional information and support. This national line is
available 24 hours a day across Australia.[75]
DoHA stated in their submission to the committee that up until midnight 13
April 2012, the line had received 3,756 calls.[76]
3.78
The committee received evidence about this hotline which indicated that
the calls are answered by registered nurses.[77]
Many submitters to this inquiry have raised concerns regarding the level of
information and support they received after contacting this hotline. These
concerns have included the feeling that the registered nurses were reading from
an "information sheet and had no real insight into the problem"[78]
and that that hotline constantly referred women back to the TGA website or
advised them to seek information from the surgeon.[79]
3.79
At the inquiry's hearing, the committee also received evidence regarding
the follow-up function this hotline was undertaking in relation to providing
additional information to women that had contacted the hotline. In particular,
DoHA had 10 registered nurses that were completing call-backs to women who had
contacted the hotline and indicated they want more information as it came to
light.
In total 2,230 original callers will receive at least one
attempt at call-back during this period if a primary contact is not made. As at
12:30 today there have been 128 outbound calls made to patients. Of these, 107
have been successful attempts and, of these successful calls, 48 calls were
longer than 30 seconds. The remainder of these will have a second attempt made
if possible within the initial period. The feedback from the nurses who are
doing the calls is that the calls have been very much welcomed by the recipient
and people were grateful to have received that feedback. A number of recipients
have said they do not have the time to listen to the full script. Obviously it
is a question of whether people have the time to listen, but, as I said, this
was thought about quite carefully in terms of whether this would be more or
less anxiety producing. But, given that people had indicated interest and had
provided their details to enable us to contact them, that is why we decided we
would proceed in this way...[80]
3.80
While the committee accepts that not all women will have the same
experience with contacting this hotline, and some may find the information
helpful, many submitters to this inquiry have indicated they found this hotline
did not equip them with additional information about the PIP breast implants
and that they did not feel supported through this process.
3.81
The impact of the PIP breast implants issue on Australian patients is
explored further in Chapter 4 of this report.
Committee view
3.82
The committee supports the establishment of the national hotline for PIP
breast implants. The committee is concerned however that the evidence provided
by individual women that the hotline did not provide the support they required.
Broader reform and implementation of recommendations
3.83
In addition to the TGA's handling of the PIP breast implants recall,
the committee received evidence regarding the need for increased transparency
in relations to all medical devices. The CHFA particularly expressed their
concerns that recommendations made from the Health Technology Assessment in
Australia (HTA Review) regarding transparency were not yet implemented.
3.84
The HTA was undertaken in 2009 and recommendations arising from this
review are in various stages of implementation.[81]
However, particular recommendations that are relevant to the PIP breast
implants issue, particularly post-market surveillance have not yet been
responded to by the Australian government; two years after these
recommendations were made. As the CHFA submission explains, these
recommendations are 13, 14 and 15 of the HTA Review:
Recommendation 13 called for the TGA to take steps to
increase the rate of reporting of adverse events, including by health service
providers and consumers, in order to improve the contribution of post-market
surveillance to patient safety. The reporting of adverse events has repeatedly
been identified by consumers as a necessity. Many health consumers would not
know where to begin if they wanted to report an issue with a device, and health
professionals have also identified concerns with current adverse event
reporting processes. Consumers have also identified the importance of providing
formal feedback to all stakeholders involved in the reporting of adverse
events, to increase confidence that action has been taken and encourage future
reporting of adverse events.
....
Recommendation 14 called for the Department of Health and
Ageing to explore options for consideration by Government to facilitate the
expansion and use of post-market surveillance data to inform safety,
effectiveness and reimbursement decisions for devices and procedures, in order to
improve the contribution of post-market surveillance to the sustainability of
the health system and the longer-term regulatory efficiency of HTA processes.
This recommendation was strongly welcomed by consumers.
Recommendation 15 called for the establishment of register
for high-risk implantable devices and/or procedures. The recommendation
followed the successful implementation of the National Joint Replacement
Registry. Consumers have seen the benefits of the registry model, and would
welcome the establishment of additional registries, with appropriate
stakeholder consultation and involvement, in conjunction with other strategies
to enhance adverse event reporting and action.[82]
3.85
The committee's 2011 report into the regulatory standards for
medical devices also discussed the HTA Review and the need to implement these
recommendations to strengthen monitoring and surveillance of devices in
Australia.
Committee view
3.86
The committee notes that recommendations 13, 14 and 15 of the HTA Review
are subject to further consideration by the Australian government. The
Australian government is yet to respond to the committee's 2011 report that
recommended the Department of Health and Ageing implement recommendations 13,
14 and 15 of the HTA Review recommendations in a timely manner. This point is
reiterated in the context of the PIP breast implants recall and should be done
as a matter of urgency.
Recommendation 11
3.87
The committee recommends that the Department of Health and Ageing
implement recommendations 13, 14 and 15 of the HTA Review recommendations as
soon as possible. The committee notes this recommendation was also made in its 2011
report on regulation of medical devices (recommendation 7).
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