Overview of the PIP breast implants situation
This chapter sets out the background of the PIP breast implants in
Australia, a description of the TGA’s role in registering and monitoring PIP
breast implants for use in Australia, and an overview of the international
response to the recall of this medical device.
PIP breast implants in Australia
PIP breast implants are medical devices, manufactured by French
company Poly Implant Prothèse (PIP), that are composed of a silicone outer
shell filled with a silicone gel.
It is estimated that 300 000 PIP breast implants were sold
worldwide before the company went out of business. The TGA,
which is a division of the Department of Health and Ageing, is responsible for monitoring
medical devices in Australia, including PIP breast implants.
PIP silicone breast implants are known to be used in
Australia from 1998
their recall in April 2010. These PIP breast implants were provided in
Australia to individual patients by a number of sponsors under the Special
Access Scheme (SAS) from 1998/99, and then were sponsored in
Australia by Medical Vision Australia Pty Ltd (Medical Vision Australia)
between 2002 and 2010.
sponsor of a therapeutic good is defined as:
The sponsor is the person or company responsible for the
importation of medical devices into Australia, and/or the supply of medical
devices in Australia, and/or the export of medical devices from Australia, as
well as making application to the TGA to have their device included in the ARTG
[Australian Register Therapeutic Goods].
An exact figure for how many Australian women currently have PIP breast
implants is unclear for some of the following reasons:
current breast implant registry works on an opt-out basis, therefore contains
limited statistical information about PIP implants and recipients;
women have since had their implants removed;
all implants supplied would have been used; and
is possible that some women received single implants instead of two.
The committee received the following summary from the Department of
Health and Ageing regarding the actual number of PIP breast implants used in
TGA records indicate that around 3 000 PIP implants were
approved by the TGA for supply under the SAS scheme or as part of the clinical
trial. Based on an audit of distribution records held by Medical Vision
Australia, the TGA estimates that around 10 000 PIP silicone gel implants were
supplied in Australia while the implants were included on the ARTG, in the
period from 2004 until April 2010, when they were recalled and cancelled from
the ARTG. The TGA does not, however, have access to data on how many of these
13 000 implants were
actually used or remain implanted in patients.
Special Access Scheme arrangements
The TGA describes the SAS as "arrangements which provide for the
import and/or supply of an unapproved therapeutic good for a single patient, on
a case by case basis".
This meant individual patients, with the support of the medical practitioner,
were able to access PIP breast implants that were available overseas, but not
The fact that this medical device was supplied in Australia before being
registered on the ARTG appears to have caused confusion amongst consumers about
the supply arrangements for this medical device. As one witness explained to
When PIP implants were placed in my body in 2001, I had no
knowledge whatsoever that PIP implants were not entered onto the Australian
register of Therapeutic Goods (ARTG) and that PIP implants could not be legally
supplied in Australia except on an Individual Patient Use basis...
In order for a patient to be supplied with an unregistered
therapeutic good, the patient must provide their informed consent. The
committee received some evidence from submitters that this informed consent was
not always obtained.
At no time was I warned that silicone breast implants were
considered 'High Risk' devices. In 2001, prior to surgery to replace my
ruptured implants, I unwittingly signed the hospital generic 'consent to
surgery' form. As it later transpired, my consent was anything but informed.
The committee considers that informed consent for unapproved therapeutic
goods is a serious issue that requires urgent reform; however it received
limited evidence from submitters who received PIP breast implants before 2004
when the PIP breast implants were not on the Australian Register of Therapeutic
Goods. Based on the current evidence, it unfortunately cannot determine how
extensive the number of women affected actually is. This in itself is an issue of
concern that also requires urgent reform.
The committee recommends that there be rigorous systems put in place to
ensure that medical practitioners provide consumers with all the information
needed to allow them to give fully informed consent.
Role of the TGA
As a division of the Department
of Health and Ageing (DoHA), the TGA is responsible for regulating the
quality of medical devices in Australia. This role is detailed in the
committee's 2011 report on the regulatory standards for the approval of medical
devices in Australia (2011 report). This report set out the various powers the
TGA has in relation to monitoring and withdrawing devices:
Chapter 4 of the Therapeutic
Goods Act 1989 provides for the regulation of medical devices. The Act
provides for various powers in relation to the regulation of medical devices
including the power to issue conformity assessment certificates to
manufacturers of a medical device; suspend or revoke conformity assessment
certificates in particular circumstances; include a medical device in the ARTG;
suspend or cancel entries of devices from the ARTG; obtain information about
medical devices; and require the recovery (recall) of medical devices, or to inform
the public about medical devices, where the devices do not comply with the
requirements of the legislation.
The committee received evidence from the TGA at the inquiry's public
hearing which clarified their role as regulating therapeutic goods for supply,
and that they are "not responsible for the regulation of medical
This was reiterated in submission from DoHA:
The TGA’s formal regulatory powers to require information
about the performance of device extend only to sponsors and manufacturers, not
to doctors and consumers.
The TGA is however responsible for approving devices to be registered on
the ATRG. As outlined in the 2011 report, the regulation of medical devices in
(a) A classification system for medical devices based on
different levels of potential risk to the patient.
(b) Manufacturers are required to demonstrate compliance with
a set of internationally agreed 'Essential Principles' for the quality, safety
and performance of the medical devices.
(c) A requirement that manufacturers implement and maintain a
suitable quality management system (QMS) for the design, production, release
and post market monitoring of medical devices.
(d) A requirement that medical devices be included in the
ARTG unless they are exempt.
(e) Medical devices available on the market are subject to
monitoring by the TGA. This monitoring includes a comprehensive incident
Australia has a risks-based regulatory framework and the TGA
classifies breast implants as a high risk, or Class III, medical device.
Under Australia's regulatory framework, the device sponsor is
responsible for making an application for a medical device to be included in
the ARTG. This application for registration includes supplying a Conformity
Assessment Certificate from an appropriate European Commission (EC) Notified
Body should a device be manufactured overseas.
regulatory framework aligns with internationally accepted best practice and
harmonises Australian regulatory requirements with the recommendations of the
medical devices Global Harmonisation Task Force (GHTF). As explained in DoHA's
submission to the committee:
The new regulatory framework strengthened the pre-market
process, particularly for high risk devices, through the introduction of a
conformity assessment process, and also strengthened post-market vigilance
requirements. An application for the inclusion of a new medical device in the
ARTG made after 4 October 2002 was required to demonstrate that the device met
the new regulatory requirements. Sponsors of existing products registered or
listed on the ARTG as at 4 October 2002 were given five years (until 4 October
2007) to transition to the new framework or have their devices cancelled from
Roles and responsibilities in monitoring medical devices
Once a medical device has been included in the ARTG, it must continue to
"meet all the regulatory, safety and performance requirements and
standards that were required for the approval".
The TGA identifies four key stakeholders involved in improving outcomes for
users of medical devices:
sponsors—who are responsible for the legal supply of
the device in Australia
manufacturers as defined in section 41BG of the Therapeutic
Goods Act 1989 (the Act)
the TGA—the Regulator
users—consumers and health practitioners who by
voluntarily reporting concerns with devices enable issues to be identified and
corrective action to be taken
Sponsor – Medical Vision Australia
Medical Vision Australia was the Australian sponsor of PIP breast
implants for the French manufacturer PIP. Medical Vision Australia was
therefore responsible for keeping up to date information about the performance
of the device, including:
any malfunction or deterioration in the characteristics or
performance of the device;
any inadequacy in the design, manufacture, labelling,
instructions for use or advertising materials of the device;
any use in accordance with, or contrary to, the use intended
by the manufacturer of the kind of device that has led to any complaint or
problem in relation to the device, no matter how minor;
information that indicates that the device does not comply
with the essential principles; and
information that indicates that an overseas issued conformity
assessment certificate has been restricted, suspended, revoked or is no longer
The committee received evidence from DoHA that a routine condition applied
to Class III devices is that the sponsor must provide three consecutive annual
reports to the TGA following inclusion of the device in the ARTG. As set out in
the Australian Regulatory Guidelines for Medical Devices, these annual reports
...include all complaints received by the manufacturer
relating to problems with the use of the device that have been received by them
over the year. Complaints received by the manufacturer relating to the use of
the device, including its supply under a different name, in other countries
where the device is available must also be included.
The evidence provided to the committee demonstrated that Medical Vision
Australia did not provide the information that would have been contained in the
annual reports until April 2010 when the recall of PIP breast implants was
undertaken and when TGA commenced its investigation.
Medical Vision Australia had not provided the required annual
reports for the first three years following inclusion of the products on the
ARTG. When this oversight was detected, the TGA requested information from the
sponsor relevant to its investigation that would otherwise have been provided
in these annual reports. This information was received by the TGA in April
The sponsor's role in monitoring the quality of PIP breast implants was
critical to monitoring performance and safety of this device once it was in the
Australian market. The sponsor's obligations are outlined in section 41FD of
the Therapeutic Goods Act 1989,
and these obligations include reporting
adverse incidents and performance issues to the TGA.
The committee was informed by the TGA that it did not ‘actively monitor’
whether annual reports were being provided by sponsors in accordance with their
obligations until 2011, and that the TGA has since instigated a procedure to
actively seek reports when they are not provided.
The committee is concerned that the sponsor of PIP breast implants did
not provide the three annual reports as required when the device was included
in the ARTG. With this requirement not being met by the sponsor, it is not
known whether issues with this device would have been raised earlier and the
current situation avoided.
It is concerning to the committee that obligations have been placed on
sponsors with little or no follow up from the TGA if those obligations were not
met. While the system now in place goes some way towards addressing this, it is
not acceptable that sponsors have not been held to account for so many years.
The Committee expresses its disappointment over Medical Vision Australia's
decision to decline the invitation to assist in this inquiry. As a result the
committee was not in receipt of all of the information it required to fully
investigate the matter.
The committee recommends that the TGA review all cases where sponsors
have not met their obligations in relation to their listing on the Australian Register
of Therapeutic Goods to ensure that these cases do not pose any health risk to
the Australian public, and that important data has not been missed.
The committee recommends that the Department of Health and Ageing
include as part of their annual report process, information on the TGA's
procedures for monitoring requirements placed on Class III medical devices.
TGA – the regulator
The Australian Regulatory Guidelines for Medical Devices sets out
what the TGA's monitoring activities are, these include:
of technical and clinical information to ensure that compliance with the
Essential Principles and conformity assessment procedures is demonstrated;
to confirm compliance with the Essential Principles;
of manufacturer’s or sponsor’s records and documentation;
testing of medical devices or taking samples for off-site testing;
of distribution records;
of the traceability of raw materials used in the manufacture of therapeutic
goods and tracking of component parts; and
analysis and reporting to sponsors.
In relation to the PIP breast implants, the TGA reviewed, evaluated and
assessed data and conducted an onsite audit of the manufacturer facility in
France. The exact details of the TGA's activities are outlined in the
chronology at Appendix 3 and the TGA's assessment of PIP implants is also
explored in more detail later in this Chapter.
The TGA also undertakes "ongoing monitoring to ensure that
regulatory compliance and safety of the medical devices continues after supply
to the Australian market".
This monitoring role is explained in further detail in Chapter 3.
When the TGA and/or a sponsor become aware of information (such as
adverse events, malfunctions or faults) about a medical device supplied on the
Australian market, either can take action. In relation to PIP breast implants,
the TGA worked closely with the sponsor regarding the recall. Events leading up
to the recall are in the chronology at Appendix 3.
Users - consumers
Australian consumers also can play a role in monitoring medical devices.
The TGA has a voluntary reporting system for consumers to report faults of
issues with medical devices they use.
The TGA then investigates these reports. The process for reporting an adverse
event is outlined on the TGA's website and includes an online form for device
Although this avenue of reporting adverse events is available to the
public, it appears to the committee that issues regarding consumers' awareness
of these processes remain poor, and many consumers would not know where to go
if wanted to report an issue with their implants. This issue was highlighted in
the committee's 2011 report where recommendations were made to improve processes
of post-market surveillance. A copy of the recommendations from the 2011 report
is at Appendix 4.
Some submitters however provided evidence to the committee that they had
lodged an adverse event report to the TGA regarding their PIP breast implants
and were not satisfied with the response from the TGA in this monitoring
process. As one individual 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.
Another submitter commented that she became a "statistic"
when she lodged an adverse event report to the TGA, and that they may now want
to speak with her as part of their investigation. The committee believes the
need for formal follow up with consumers once a report has been lodged is vital
to increase confidence that action has been taken and encourage future
reporting of adverse events.
It is also important to note that the lack of adverse event reporting by
health professionals to the TGA was raised during the committee’s previous
inquiry into medical devices, with Recommendation 8 (Appendix 4) of that report
specifically addressing this issue. It is clear from evidence provided to both
the previous inquiry and to this inquiry that consistent, comprehensive adverse
event reporting by all parties is required to allow the TGA to act quickly and
appropriately when these problems occur.
Adverse events – reports of PIP
breast implants rupturing
Ruptured breast implants is considered an 'expected event' therefore sponsors
and manufacturers are not required nor expected to routinely report these
events to the TGA.
However, the committee heard from patients that may view their ruptured
implants as an adverse event as it had affected their lives (refer Chapter 4
for more detail). The consumers reporting of this type of event are of course
dependent on their awareness of this process and their willingness to engage
with this process with the TGA.
The first adverse report with PIP breast implants occurred in 31 October
2002 (under SAS arrangements).
It is not clear from the evidence whether this initial report related to a
rupture. Between 2002 and 2010 when the device was
recalled, the TGA received
34 reports of adverse events in relation to PIP implants. All except for
three reports were from either the sponsor or manufacturer and the majority (25)
related to reports of rupture.
According to recent TGA figures
there was as a marked increase in confirmed ruptures in 2012, from 37 confirmed
ruptures on 4 January 2012 to 287 confirmed reports of ruptured PIP breast
implants on 25 May 2012. Of these 287 reports, 80 were made
by consumers, 183 by surgeons and 24 by the supplier.
The TGA's Pre market assessment of
PIP breast implants
In April 2003, the Australian sponsor of PIP breast implants, Medical
Vision Australia made an application to the TGA for a Conformity Assessment
to be issued to PIP for manufacturing of silicone gel pre-filled breast
implants. The TGA cannot exercise any of its regulatory powers outside Australia;
however it can conduct an audit of an overseas manufacturing facility through
arrangement with that manufacturer.
The TGA undertook a conformity assessment review for PIP breast implants over
an 18 month period. This review included an onsite audit of the manufacturing
facility in France, an examination of the design of the PIP implants, and an
assessment of clinical evidence.
The TGA conducted the onsite audit of the facility in France 17 –
19 November 2003. This audit determined three major and three minor
'non-conformities' which were explained in DoHA's submission to the committee:
The first major nonconformity was a problem with construction
and maintenance of a cleanroom, where there were gaps in the vinyl flooring,
unsealed holes in the wall of the envelope filling room and unsealed edges on
benches and storage cabinets. This was a potential problem because of the risk of harbouring
microorganisms that could potentially contaminate the product. The second major
non-conformity was identified because an external door and internal door to the
raw materials receiving area were left open simultaneously, exposing the area
to potential contamination or allowing pests to enter. The third major
non-conformity related to the company's methods for demonstrating that
contamination had not occurred.
While all three of these major non-conformities pointed to
the potential for contamination of the finished product, no evidence of
contamination was found and the non-conformity finding was issued so that
appropriate corrective actions could be put in place to prevent the risk from
The first of the three minor non-conformities related to
failure to apply a unique internal lot number to raw materials, where
subsequent deliveries from the manufacturer had the same lot number as an
initial delivery. The second minor nonconformity related to incorrectly
applying quarantine labels to drums of raw material used to make the shell of
the implants. The final minor non-conformity was that photocopies of certain
standard operating procedures were found, when the quality management system
clearly prohibited the copying of these documents.
The manufacturer supplied further information relating to these
identified non-conformities on 15 December 2003 and the audit report was closed
on 23 August 2004.
During this time, the manufacturer had obtained a European Commission
Conformity Assessment Certificate (March 2004) from a European Notified Body.
The Australian sponsor also provided clinical data to support the
application for registration and at that time, the TGA clinical evaluator noted
the data's limitations:
The clinical data submitted in January 2004 by Medical Vision
Australia in support of the conformity assessment certificate application
consisted of a trial of 265 patients with a one year follow-up.
The clinical trial was retrospective, unblinded and
uncontrolled. It provided safety data extending to one year with respect to the
patient group. No ruptures or extrusions were reported in the trial although 12
contractures were observed. Thirty three patients experienced other, less
frequent adverse events. Data on the number of implants worldwide and the
number and types of adverse event reports were received in March 2004. There
had been 103562 PIP silicone gel filled implants distributed worldwide at the
time of submission. Corresponding adverse event reports numbered 205. With
respect to Australian adverse events there were seven reported to the TGA
including five ruptures and two gel extrusions/leakage. These data supported
the safety profile of the device.
The TGA clinical evaluator noted the limited nature of the
clinical data submitted, but also reasoned that arguments for essential
similarity with other implants of similar design and materials should be taken
None of the other components of the evaluation raised any
major concerns in relation to the efficacy, quality or safety of the PIP
silicone gel-filled breast implants.
The TGA clinical evaluator then referred this application for
registration to the Medical Devices Evaluation Committee (MDEC) in September
2004 for decision. As reflected in the Department of Health and Ageing's
[The] MDEC advised that it had no objection to the inclusion
of these implants on the ARTG for cosmetic breast augmentation and
postmastectomy breast reconstruction, but recommended that approval should be
subject to the provision of comprehensive annual post-market reports to the TGA
for evaluation for a period of seven years from the date of approval.
Despite the recommendation from MDEC, the delegate approved
inclusion on ARTG in 2004 but did not impose the requirement for seven annual
No further explanation was provided by the Department regarding this decision. It
should be noted that the MDEC has now been replaced by the Advisory Committee
on Medical Devices which was established on 1 January 2010 through changes made
to the Therapeutic Goods Regulations 1990.
The committee is concerned that the TGA approved PIP breast implants for
inclusion on the ARTG without imposing the requirement for seven years of
annual reports as recommended by the Medical Devices Evaluation Committee.
The committee recommends that the TGA put in place measures to ensure
that when recommendations made by the Advisory Committee on Medical Devices (formally
the Medical Devices Evaluation Committee) are not followed, the delegate needs
to set out specific and compelling reasons why the decision was taken.
of PIP breast implants
The TGA registered PIP breast implants on the ARTG in 2004, with
the Conformity Assessment Certificate expiring in October 2009. Medical Vision
Australia advised the TGA in 2009 that they had EC certification and that they
would "vary the manufacturer's evidence supporting the nine ARTG
entries from the TGA certification to EC certification".
This variation was accepted by the TGA in September 2009 and the PIP breast
implants remained on the ARTG under European recognition arrangements. These
arrangements include medical devices being included on the ARTG through a
conformity assessment certification which is issued under provisions of a trade
facilitation agreement with European countries.
These mutual recognition arrangements in relation to conformity assessments are
outlined in more detail in the 2011 report.
On 8 December 2011, the Australian government noted in its response to
the TGA Transparency Review that:
Regulatory provisions relating to the use of third party
assessment bodies and increasing premarket scrutiny of implantable medical
devices are linked to recommendations of the recent Senate Community Affairs
References Committee inquiry into ‘The standards for the approval of medical
devices in Australia’ These remain under consideration and further consultation
The committee notes the response to the 2011 report has not yet been
received and urges the Australian government to consider its response to
strengthening premarket assessments in the light of the PIP breast implants
issue as a priority.
Advice from French Regulator regarding PIP breast implants
The French regulator, AFSSAPS
advised the TGA and Medical Vision Australia on 31 March 2010 of its decision
to recall and suspend the marketing of silicone breast implants manufactured by
PIP. As explained in the Department of Health and Ageing's submission, this
decision was made by the French regulator because it had:
“registered” an increase in reports regarding implant rupture
and local complications and had discovered that the company had used an
unauthorised silicone gel in the products.
Following this advice, Medical Vision Australia withdrew all
non-implanted PIP breast implants from the Australian market on 6 April 2010.
After recalling the medical device from the Australian market, The TGA removed
PIP breast implants from the Australian Register of Therapeutic Goods (ARTG) on
14 April 2010.
Non-implanted PIP breast implants were recalled from the Australian market
in 2010. However the matter did not attract substantial media attention in
Australia until further actions were taken in late 2011 by various regulatory
bodies overseas. The impact of the media coverage is covered in Chapter 4 of
this report, as is the experiences of Australian women with PIP breast implants.
International responses to the PIP
breast implant recall
The PIP manufactured implants caused global concern after advice was
issued by the French regulator, AFSSAPS, that these implants contained
industrial silicone rather than medical-grade fillers and that they may be more
prone to rupture and leakage than other implants. Of most concern were initial
reports linking the PIP breast implants to a rare form of cancer known as ALCL.
This link has been now been discounted by medical experts in the United Kingdom
(UK) and Europe.
Different countries took different courses of action following the
advice about the use of unauthorised materials. France, Belgium, Germany and
the Czech Republic all advised women with PIP breast implants to have them
The French Government in particular advised women to consider having their
implants "surgically removed as a non-urgent precautionary measure"
and while removal would be paid for by the state, the costs of replacement
implants would only be met for those who received the implants as part of
reconstructive surgery for breast cancer.
The UK however has stated there was not enough evidence to direct
routine removal of breast implants.
This is reflected in the UK House of Commons Health Committee report into PIP
breast implants and regulation of cosmetic interventions:
In the absence of evidence the policy response has become one
of judgement and caution rather than scientific imperative.
The UK National
Health Service (NHS) has
decided to support the removal of PIP breast implants if the patient decides
with her doctor that it is right to do so. However, the UK will only replace
the implants if the original operation was done by the NHS.
Commission's Scientific Committee on Emerging and Newly Identified Health
Risks released their report on the PIP implant
1 February 2012 and concluded there was no evidence to support a recommendation
that women with PIP implants who do not have any problems with their implants
should have surgery to remove or replace them.
In addition to the
UK House of Commons report into PIP breast implants, the UK has also initiated
multiple reviews regarding this issue. Specifically, the reviews include expert
assessments of the evidence relating to the medical risks associated with PIP
implants, a review into the actions of the UK's regulatory body responsible for
regulating medical devices, the Medicine's and Health Care Products Regulatory
Authority (MHRA) and a wider review into the regulation of cosmetic
In Australia, the TGA continues to monitor evidence relating to PIP breast
implants and issue regular alerts with updated advice.
On 15 March 2012, the UK Chief Medical Officer (CMO), Dame Sally Davies
wrote to general practitioners to highlight information which the MHRA became
aware of in relation to PIP implants. This advice was in addition to
correspondence sent to medical practitioners on 6 and 27 January 2012. The UK
CMO encouraged practitioners to check their records and identify patients who
received PIP implants, however confirmed advice that no routine removal of PIP
implants as a precautionary measure was necessary.
This correspondence identified that some private providers were "falling
short" in their responses to women coming to them with PIP breast implants
(similar to experiences shared by some Australian women which are detailed in
chapter 4). Dame Davis encouraged practitioners in the UK NHS to provide
"all necessary reassurance and support for patients of private clinics
who, for whatever reason, come to the NHS for help."
In response to questions Dr Fleming explained that PIP silicone implants
were not approved for use by the Food and Drug Administration (FDA) in the
You have to understand that the FDA had not approved any
silicone implants between 1992 and 2006. At this point in time it has only
approved three brands—Mentor, Allegan, Silimed—because the FDA requires
specific long-term pre-marketing approval studies for any brand of implant
before it approves that particular brand. To my knowledge PIP never underwent
those tests in the US for its silicone implants.
Chronology of events in relation to
PIP breast implants
DoHA provided the committee with a chronology of events leading up to
the device recall in 2010. This chronology reflects the TGA pre assessment
process, including the onsite audit of the facility in France and the MDEC
decision. This chronology is at Appendix 3.
Actions taken by the Australian Government, including the TGA, following
the recall of PIP breast implants in Australia is explored further in Chapter
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