Summary of key issues
The scope of this inquiry was narrow in that the terms of reference focussed
particularly on the TGA's role in managing the PIP breast implants recall in
Australia. The committee received useful evidence over the course of the
inquiry, however the data it received is limited in terms of 'unknown'
information, such as how PIP breast implants compare with other silicone
implants, and what the level of risk is from PIP implants.
Although the scope of this inquiry was limited, the PIP breast implants
situation has raised some key issues regarding the TGA handling of medical
device recalls. These include:
- The critical need for the TGA to issue regular updates to
consumers, medical practitioners and suppliers regarding device recalls, and
the importance of including what information they know and what information
they are developing, including what evidence is being gathered through further
testing or follow up with international regulators.
- The importance of monitoring and following up conditions that are
placed on sponsors when a medical device is included in the ARTG, not just when
an issue is identified.
- The need for comprehensive and accurate data collection when patients
receive implants so this can be drawn on in the event of a device recall.
- Post market surveillance is critical for monitoring the
effectiveness of medical devices, and the role that everyone plays in this
process is not always clear.
- Where consumers have raised issues, such as breastfeeding with
implants, this needs to be addressed in formal advice from the Australian
During this inquiry, the committee did not receive any evidence
regarding general safety issues with silicone breast implants. It is unclear
whether the issues raised during this inquiry are specific to PIP breast
implants, or whether breast implants in general can lead to similar outcomes.
This chapter outlines key areas which remain unclear to the committee based on
the current information.
Comparative rupture rates of breast
The committee received evidence that all devices have risks and
implantable devices are likely to have a failure rate.
What remains unclear is whether risks identified with PIP breast implants are
the same as all other silicone breast implants. The Australian government
advice on PIP breast implants remains as follows:
Testing undertaken by TGA to date has not found evidence that
the risks involved with the use of PIP breast implants are any greater than
those for any other brand of silicone gel-filled breast implants.
Following the recall, the TGA reviewed its data regarding the number of
reports of rupture of PIP breast implants as well as other adverse events
associated with this device:
From 2002 to April 2010 TGA had received 22 reports relating
to rupture of PIP implants. At 4 January 2012 the number of reports relating to
rupture was 37.
As at the 25 May 2012, the TGA had confirmed reports of PIP breast
implants was ruptures was 287.
This is a significant increase in reported ruptures; however the TGA update
does not provide further explanation regarding this increase since 2010.
Some submitters referred to data that highlighted higher rupture rates
of PIP breast implants which seemed to fuel patient anxiety in light of the TGA
advice stating risks with these implants were the same as other silicone
implants. As one submitter explained:
I was advised that an Australian Plastic Surgeon..., was also
experiencing a 20% rupture rate from his PIP patients. So I was aware that there
was a real problem with the PIP breast implants including an unacceptable
rupture rate and many women suffering distressing symptoms (with or without
This reported rupture rate was made by Dr Timothy Cooper, and in
response to this report, Dr Richards from the TGA explained:
The evidence is that most of these women had a rupture on one
side and an intact implant on the other. That is in fact a rupture rate of the
device of around 10 per cent. That is how rupture rates are usually quoted in
the international literature and the FDA reviews. Dr Cooper reported an
experience of 20 per cent of his patients having had a rupture, which is around
the same as saying a 10 per cent rupture rate.
Rupture is a known complication of any type of breast implant,
whether it is saline or silicone, whether it is PIP or any other brand.
Ruptures are a common event.
At this inquiry's hearing, Dr Fleming of Australasian College of
Cosmetic Surgery that, told the committee the rupture rates of PIP breast
implants are not yet known and MRI scanning will be critical to determining the
true rupture rates of these implants:
We have a huge number of people out there who have had MRI
scans. Not only that; if they have a rupture on the MRI scan they will be
having surgery which will confirm or deny the accuracy of the MRI scan. We know
what rupture rates are from MRI scans and from the FDA studies of Allergan and
Mentor implants. We know, for example, Mentor implants have a rupture rate of
13.6 per cent by 10 years after implantation. I believe—and it is just based on
anecdote, on what I have seen and from talking to my colleagues since we have
had these MRIs available to us—that there is an increased rupture rate with PIP
implants and I believe that there is an early spike.
The TGA continues to test PIP breast implants and the TGA expert panel,
at its meeting of 17 May 2012, noted data from the subsidised MRIs over the
next year will assist in ascertaining the rupture rates of PIP implants.
This expert panel also noted:
...the importance of clinician engagement in any
epidemiological studies designed to investigate rupture rates further and
encouraged implanting surgeons to actively participate in any such study.
The fact that rupture rates for PIP implants is not known was also
reiterated by the Department at the hearing:
The evidence in relation to the actual rupture rate for PIP
implants is still not conclusive. No-one really knows...
We understand that a number of surgeons and radiologists are
collaborating to try and collect better data now that more women are having
access to MRI scans. So in 2010, when these devices were recalled, there was no
suggestion that they were likely to have an increased rupture rate compared to
other modern breast implants... But, as 2012 has evolved and more and more
women who, frequently, have no symptoms are having MRI scans and discovering ruptures,
we are gradually getting better data, but we do not have a definitive rupture
The committee is of the view that given the true rupture rate of PIP
breast implants is not yet known, and that only further data collection and
studies will determine this, then this should be reflected in the official
advice issued by the TGA.
The committee recommends that the TGA include in their advice that it is
unclear whether PIP breast implants rupture more than other silicone breast
implants and that further testing and investigation of PIP breast implants will
continue to inform this advice.
Manufacturing quality control for
PIP breast implants
It also remains unclear to the committee whether the critical concern
with PIP breast implants is the manufacturing quality control. As Dr Fleming
advised the committee, the 'spike' in an increased rupture rate may be
attributed to practices undertaken in developing these implants:
I do not know is whether or not that is due to poor manufacturing practices or
poor quality control rather than something intrinsically weak in the implant
because unapproved gels were used.
The French regulator advised in recalling the device that the
manufacturer had replaced 'unauthorised silicone gel' for the silicone gel
which had been approved for use.
In response the TGA tested un-implanted PIP breast implants during April, May
and June 2010 to assess the risk of this device, particularly in regard to risk
of rupture and the gel toxicity:
Testing involved samples from eight batches of product
covering a range of sizes and dates of manufacture and included both smooth and
textured shells. Samples were tested with respect to their physical and
mechanical properties (resistance to rupture) as well as for cytotoxicity (that
is, propensity to cause damage to cells). The shell and gel of implants were
found not to be cytotoxic and tensile tests on the shell material and the shell
seams and seals showed that the implants met the requirements of the applicable
In January to April 2012, the TGA also undertook a review of the 2003
onsite audit of the French manufacturer PIP and the findings remain:
...that the documentation reviewed by the TGA auditors
contains no irregularities that would have signalled the intention of PIP to use
unauthorised silicone (filler) in the implant. The specification for the
silicone implant material reviewed by the auditors was consistent with the
material submitted and approved by the TGA.
It is still unknown whether the unauthorised silicone used by the PIP
manufacturer is dangerous and will cause adverse health implications for
patients. The committee heard evidence stating silicone in itself is not toxic
and there is not much difference between 'industrial' and 'medical grade'
However, this is little comfort to Australian patients that may have implants
made of unauthorised silicone with the chance of the implants rupturing and this
spreading in the body.
The TGA continues to test implants throughout 2012 and there continues
to be no "specific safety concern for PIP breast implants" identified
from mechanical, toxicology or chemical tests carried out.
The committee notes that there is limited evidence regarding whether
poor manufacturing has contributed to the current situation with PIP breast
implants. Further, it is unclear whether implants with unauthorised gel have
been used in the Australian market which only testing of implants that have
been removed will determine. The committee strongly urges the TGA to undertake
testing of explanted PIP implants as a matter of priority to inform official
advice about PIP manufacturing quality.
There is no denying the PIP situation has generated concern and distress
amongst Australian patients. Australian women have been adversely affected
through this process as many have indicated health concerns, particularly
anxiety which in itself is an illness.
Given the situation, information should be as accessible as possible,
for both consumers and medical practitioners so they can support their patients
in advice they provide. Issues regarding clear communication and processes for
accessing information and reporting problems with medical devices are not new
and have been raised before with the committee.
While consumer input is invaluable to the monitoring of the performance
of medical devices, consumers often do not know how to navigate and interact
with complex regulatory systems so information needs to be tailored,
comprehensive and easy to find in order to be effective.
There are multiple players in the medical system that all play important
but distinct roles. Patients navigating this complicated system, particularly
in distressing situations, do not need to encounter responses that simply refer
them on to other professionals or to be told that there is nothing anyone can
do. The PIP breast implant situation highlighted shortfalls at many levels, and
all those involved need to adopt a considerate and informative response to women
with PIP breast implants.
Senator Rachel Siewert
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