Personal impact of PIP breast implants on Australian patients
The committee has concerns generally about the adequacy of the advice
given to women considering breast implant surgery. It is important that
patients have a full awareness of the risks of all breast implants. There is a
real need for full advice to be provided prior to surgery about these risks,
how long the implants will last, and the post surgical medical support that
will be available.
The committee received evidence from many women who have had PIP breast
implants for a variety of reasons ranging from cosmetic through to
reconstructive purposes. Regardless of the reason for receiving PIP breast
implants, the following areas of concern were common:
- A general lack of awareness by women that they were receiving PIP
- Ongoing health issues since receiving PIP breast implants;
Confusion and distress as a result of the information made
available to the public (i.e. official technical advice issued by the TGA and
- Lack of support from surgeons who conducted the implant surgery;
- Inability to access MRI facilities in some areas.
This chapter explores these key areas and draws on evidence to highlight
issues that were raised by submitters to this inquiry. It also sets out the
committee’s views and recommendations, where relevant, in each area.
Lack of awareness about PIP breast
A consistent theme of evidence provided to the committee was the lack of
awareness by consumers that they had received PIP breast implants in the first
place, followed by a lack of awareness by consumers that there was an issue
with PIP breast implants in 2010.
Some submitters told the committee that they were not provided
information about the implants and the manufacturer when they were considering
breast implants, and that this denied them the opportunity to undertake
research to further inform their choices. As one submitter advised, she had:
...met with a number of cosmetic and plastic surgeons
throughout Perth to discuss the surgical correction of my asymmetry. As a close
friend had undergone breast augmentation with surgeon A, I decided to proceed
with his services. I underwent surgery on 17 April 2007, when surgeon A
inserted PIP devices into my left and right breasts. I was not given a choice
of implant manufacturer.
...I wasn’t even told what he was using. I did not even
receive a card with my implant information on it.
Many submitters provided evidence indicating they found out about issues
with PIP breast implants through the media in 2011/12, and then had to check
their personal medical files to determine whether they had implants
manufactured by PIP:
After watching the 60 minutes program on 11th March 2012, I became concerned that I may
have these PIP implants. After an extensive search of my house and old files I
located my breast implant card and was devastated to learn that I had PIP
implants. I was even more upset to learn that in April of 2010 the implants had
been recalled, and yet I had heard nothing from my surgeon...
As one submitter reflected in her submission, she had to contact the
surgeon herself to determine what type of implants she had received:
After seeing several news stories regarding PIPs and their
scrutiny in the media, initially, I wasn't concerned, as I had received no
contact from surgeon to inform me that these were the implants that I had. I
wasn't aware at the time that I was a recipient of PIPs. After several more
stories were frequenting local news I decided to email my surgeon for
confirmation of the brand of my implants. To my shock I was informed that I had
PIPs and should see a doctor and schedule a removal...
Other submitters were aware the TGA had advised surgeons to contact
patients about this issue, however reflected that no one had contacted them,
despite the device being recalled in 2010.
I am aware that they were recalled in April 2010. I am aware
it was suggested that surgeons and clinics should contact their patients. They
Legal firm Tindall Gask Bentley provided evidence to the committee that
a lack of communication from surgeons to women with PIP breast implants was a
critical issue. As Mr White advised the committee at its public hearing:
The TGA initially indicated that they wrote to the sponsor of
the implants requesting that the sponsor write to the doctors that had used
these implants. That was the initial position that the TGA advised in 2010.
Subsequently, in one of the statements by the TGA—I think it was 23 March
2010—they said that they wrote to the doctors direct in January 2012. What I am
hearing from a lot of women is that they are still being contacted up until
recently by doctors, and this is the first occasion that they are hearing from
doctors that they have PIP implants. It is now well over two years since the
withdrawal of them, and women are telling me that they are only just being
contacted by doctors to advise them that they have these implants. My point is
that there is a massive breakdown in communication here.
The TGA provided evidence to the committee that the responsibility for
contacting surgeons and patients does not fall within their remit. In addition
to explaining that the TGA is not responsible for regulating medical practice,
the acting National Manager of the TGA stated:
...sponsors are required to keep records of people to whom
those devices have been supplied so that in the event of a recall those people
can be contacted, and that is the sponsor's responsibility.
The TGA did however acknowledged that they understood that there was a
lack of awareness among consumers about this issue and, in the evidence
provided to the committee, indicated that the TGA did take action to encourage
surgeons to contact their patients.
Dr Richards...Because we could not get the results and
we could not wait for the results, we thought we had better make sure the
surgeons contact their patients. It is a professional responsibility that the
surgeons have; it is a duty of care that they have. We provided the surgeons
with the additional information. So the TGA medical officers came in on a
weekend in early January  and tried to call all the surgeons, and
surprisingly got a lot of answering machines on a Sunday. They came in the next
day and continued to contact them, and we sent registered letters. We got a
list from the sponsor of all the surgeons and we sent registered mail to the
surgeons to ensure that the surgeons received the information and were
encouraged to contact their patients. We can lead horses to water, Senator—
Senator MOORE: That was the first time the TGA had direct
communication with the surgeons?
Dr Richards: Individual surgeons, because prior to
that we took the view that that was the responsibility of the sponsor, and the
sponsor had done that. We were getting reports from patients that they had not
been contacted, so we took additional steps to encourage that to occur.
The committee is concerned that consumers receiving implantable devices
have been provided with limited information about the device itself before
surgery. The committee considers it a fundamental duty of medical practitioners
to provide patients as much information as possible to allow them to make
Further, the committee is concerned with the limited follow-up from some
surgeons to their patients regarding the PIP breast implants recall. Better
data collection practices in the future may alleviate some issues identified
with this process. The committee strongly believes that surgeons have a
responsibility to proactively engage with their current and former patients
over issues and concerns with implanted medical devices.
The committee also notes that similar issues were raised during this
committee’s inquiry into medical devices, which would appear to point to
serious problems with the current system. The committee strongly advises the
TGA, through the CMO, to consider providing medical practitioners with
guidelines stating the TGA’s expectations of them in these situations.
The committee strongly recommends that professional bodies, particularly
the ASPS and ACCS, ensure through formal advice that surgeons are aware of
their responsibilities to ensure that they provide an ongoing advisory role to
their patients even after medical treatment has concluded.
Ongoing health issues
Although evidence about the health issues that individual patients
encountered differed, the committee did receive common health complaints from
women who had PIP breast implants. An example of the health issues are listed
below in a submission made by Ms Jodie Blake:
Breast pain, shoulder blade pain, neck pain, arm pain,
Joint muscle pain, ovary pain, Chest pain.
Short term memory loss.
Swelling, fluid retention, Inflammation
Breathing issues/shortness of breath
Excessive hair loss, dry hair and skin problems, rashes
allergies, sensitive to heat and cold.
Low blood pressure, low blood sugar, dizziness/seeing stars
vision issues, sensitive to light and sound, ringing in ears.
Anxiety depression, hormone issues, dead limbs in sleep.
Rupture related: swollen enlarged breast, lumpy breast.
Burning sensation. Excessive stretching which in turn has disfigured my breast.
Recurring chronic abdominal pain and bowel problems, which I
was hospitalised for requiring intravenous antibiotics to clear infection and
anti-reflux medication and morphine for the pain.
In addition to the health issues identified above, many women described
experiencing soreness and tingling in limbs,
and complications with lymph nodes containing silica.
Many submitters spoke of the personal impact these issues have had on
different aspects of their lives in addition to the health issues, such as:
- Inability to work on a full time basis due to health issues;
Adverse impact on engaging with their children effectively;
Financial impact through not being able to work and out of pocket
expenses for surgeries;
- Significant anxiety and mental stress.
The CMO, Professor Baggoley, noted the level of the consumer anxiety and
distress in his report on PIP breast implants:
Consumers have provided reports to the TGA on their
experience with PIP breast implants. These reports are on local breast implant
complications such as rupture and contractures, and anxiety and distress. A
number of the consumer reports also described the consumer experiencing
systemic symptom/s, such as fatigue, general malaise, hair loss and headaches,
which are reported to be associated with their implant. The TGA is seeking
consent from these individuals to contact their treating doctor to gain further
information on the nature of their symptoms, and the results of any
Systemic or general symptoms, such as fatigue and headache,
may be experienced as part of many different health conditions. It is important
that women experiencing these symptoms visit their medical practitioner so that
a personalised review can be carried out to exclude other underlying
The committee acknowledges the common health issues and adverse
experiences of Australian women with PIP breast implants, particularly the
emotional and financial stress this situation has caused.
The committee is encouraged by the TGA's steps in contacting individual
treating doctors about symptoms, however would suggest more can be done in
terms of acknowledging that it is ultimately the responsibility of the surgeon.
Professional bodies, such as the Australian Society of Plastic Surgeons and the
Australasian College of Cosmetic Surgery should be contacting their members and
issuing formal advice about being cognisant of the personal distress these
situations create and maintaining the highest standard of medical practice.
Breastfeeding mothers with PIP
A key concern expressed to the committee from women was the issue of
breastfeeding while having PIP breast implants and the potential health impact
this has had on their children. As one submitter explained:
I have been left with industrial grade silicon and other
chemicals inside of me, potentially endangering my child and myself.
We don’t know the long term effects that these implants may
or may not have on our health. I hope every day that by breastfeeding my
daughter unaware for 4months and three weeks that there will be no side effects
to her, or long term health problems. Again I live with the guilt and the
unknown. There is no definite proof over the long term effects or not on my
daughter. I hope I am worrying for nothing but I just do not know. Had I known
earlier then this could have at least been fixed.
One submitter spoke of the health issues her child experienced since
birth which may be attributed to breastfeeding with ruptured PIP breast
My ultrasound report was both implants ruptured with right
hand side silicone in lymph nodes. Left one was leaking. I went into panic and
shock. My baby was under 10 weeks old and I immediately stopped breastfeeding
as I couldn't bare even the thought of feeding him through potentially toxic
and unknown substances in my breast. He already had enough health problems
My recent baby was born with fluid on his lungs, enlarged
lymph nodes and cyst on his adrenal gland. I had a tougher pregnancy with him
with a lot of pain on my right side ie pelvis, kidney, abdominal and headaches.
He was born at 36.5wks. When he was around 5 wks old I was rushed to emergency
in an ambulance again with unexplained right side pain.
When questioned about the potential risk of breastfeeding with these
implants, Dr Daniel Fleming from the Australasian College of Cosmetic Surgeons
provided the following explanation:
The silicone molecules are too large to get into the milk and
there is more silicone in supermarket milk than there is in the breast milk of
women with silicone breast implants.
The UK Breastfeeding network has issued advice stating that although
there have been no studies regarding the passage of gel contained in PIP breast
implants, in general:
Silicone by nature is extremely inert and is unlikely to be
absorbed in the GI tract by a nursing infant although good studies are lacking.
Silicone is a ubiquitous substance, found in all foods, liquids, etc.
The TGA has also issued the following advice regarding health impact on
babies from mothers with PIP breast implants breastfeeding:
No toxic chemicals have been found in PIP breast implants
(whether intact or ruptured) that are likely to affect the production of breast
milk (lactation) in a woman with either ruptured or intact breast implants, or
have any effect on the health of breast-fed babies.
The Chief Medical Officers (CMO) report on PIP breast implants which was
published on 7 May 2012
was silent on the issue of breastfeeding.
The Committee understands the deep concern felt by mothers concerning
the effect ruptured implants could have on their children through
breastfeeding. The committee notes the advice provided by the Therapeutic Goods
Administration about breastfeeding children with PIP breast implants, however
also noted the limited nature of evidence regarding the impact breastfeeding
while having ruptured PIP breast implants.
The committee recommends that the clinical advisory committee established
by the Chief Medical Officer should develop advice, based on current evidence
regarding breastfeeding and PIP breast implants, as soon as possible, and that
this information be included in future Chief Medical Officer reports on this
Confusion with public messages
The committee heard from many submitters that part of their level of
anxiety about the PIP breast implants resulted from contradictory public
messages issued by the Australian Government and media reports.
The contradictory messages resulted from the TGA and CMO publicly
advising that testing found no 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 and recommended 'no routine removal of implants'
whereas the media reports broadcast by current affairs programs, 60 Minutes
(Channel Nine) and Sunday (Channel Seven) on 11 March 2012 stated women
were living with "toxic time bombs".
An example of this confusion with messaging in the media as opposed to
what the TGA was recommending was highlighted by Ms Telford who stated she:
...was absolutely mortified and worried after reading all of
the reports and media stories. I was also extremely confused, as reports from
the TGA were conflicting with other things I was reading. Here we had the TGA
saying they are fine, no cause for alarm and there's no evidence suggesting
they are poisonous or that they rupture any easier or faster than other types
These things are known to be made with none medical grade
silicone! I am sick of hearing the TGA telling us that there is no evidence and
they need to be tested...
This contradictory public messaging contributed to Australian patients'
anxiety with this issue. Professor Rodney Cooter from the Australian Society of
Plastic Surgeons stated there was:
...unresolved anxiety out there and while that exists it is
clear that patients would prefer to have the implants out. There is still a lot
of doubt. The science that has been done is very robust, but there are still a
lot of unanswered questions that, hopefully, will not be answered in a negative
As noted earlier, many submitters have stated they became aware of
issues with PIP breast implants through the media and not from the TGA or their
surgeons. While the committee accepts that not all individuals were adversely
affected by becoming aware of this issue through media reports, and notes some
women were grateful they were made aware of the issues through the media,
many submitters stated that their anxiety increased as a result of the coverage:
All the while being sick with worry and not knowing what it
was that I had implanted. News headlines reading “Ticking time bombs” and
adding to a very stressful situation.
The Sixty Minutes program came as a shock to me on
11/03/2012. I had missed the media attention prior to this surrounding PIP
breast implants. Of course I went and checked my file at home and was just
dismayed to find that this was what I had in my body and no-one had bothered to
After seeing information about PIP’s on the television on the
11th of March 2012 I called the agency I
went through for my surgery to find out if I had these implants, never
expecting that I actually would. When they confirmed I did have the PIP’s I was
devastated and became an emotional wreck! I vomited and cried on and off for a
couple of days and I couldn’t sleep, I was so distressed about what I had in my
Some submitters indicated that it was a combination of media coverage
and lack of information from the TGA that contributed to their anxiety about
PIP breast implants. As one submitter explained:
News headlines reading “Ticking time bombs” have made it
impossible not to panic about the risks to my health and the TGA’s information
and advice helpline provided me with very little information and no comfort.
The committee heard from the Consumers Health Forum Australia (CHFA)
that media reports can exacerbate public concerns, particularly when there is
an apparent lack of public information on the issue:
We know there were some very vulnerable women—for example,
women who were pregnant—and, when the scare stories went into the mainstream
media like 60 Minutes, there were women turning up to their GPs, asking
if they should have terminations of their pregnancies... These were very
vulnerable women, and misinformation like that which happened in the mainstream
media really occurs when there is an information vacuum. 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.
DoHA advised the committee that there was a 'spike' in consumers' calls
to the Breast Implants information hotline following media reports airing in
March which may be a reflection of the anxiety generated from the coverage.
The Australasian College of Cosmetic Surgery (ACCS) however indicated
that the TGA's communication strategy did "not keep pace with its world
leading testing and analysis work"
however also stated that the media reports had let Australian women down.
The reliance largely on web-based information for patients
and the lack of a more proactive communication strategy has created a vacuum
which has been filled partially with inaccurate information. The result has
been to undermine the public’s confidence in the TGA, which has further harmed
women already understandably concerned about their health. Members of the
College are seeing the consequences of this in consultations with patients
Dr Fleming, in his capacity representing the ACCS at the public hearing,
reiterated this point to the committee, stating the media coverage was
'sensationalistic' and undermined the public confidence in the TGA:
...do not underestimate the effect that this undermining of
confidence in the TGA has had on patients, to the extent that I have had
patients who have been considering aborting wanted pregnancies for fear of
damage to their unborn children from PIP implants—and there is absolutely no
medical reason or evidence behind that at all. They have simply been terrorised
by sensationalistic media reporting, which has not been matched by a
sufficiently robust communication strategy from either the TGA or the
The CHFA indicated that the TGA had actively taken steps of alerting the
Australian public to the issues with the PIP breast implants and that they
welcomed the "move towards increased transparency and improved
communication from the TGA".
The committee received evidence that the TGA has responded in a
"timely, appropriate and evidence based manner to concerns"
with PIP breast implants, however communication about the issues and
information sharing could always be done more effectively.
The individual women who provided evidence to the committee however did not
often view this messaging in the same light, often questioning the rationale
that lead to the recommendation that immediate removal was not necessary:
If the product is safe enough to be left in our bodies in the
TGA’s opinion, why have they stopped the sale of the device for new procedures?
The regulatory bodies of other advanced Western societies such as the UK,
France, Germany and the USA have announced that the product is not safe.
The TGA has issued 33 alerts, updates and information (including
consumer questions and answers) on their website since April 2010.
The committee heard from the TGA that although their role is not to regulate
medical practice, they did encourage doctors to contact their patients on this
issue as they do not have to power to direct surgeons to contact individuals.
Dr Richards explained to the committee:
...advice from the TGA to consumers, to patients, was to
contact their doctor.
The TGA has no role in regulating medical practice and does
not record, nor has it the authority to record, details of individual patients
to whom these devices are supplied.
The communication provided by the TGA appears comprehensive; however
this is only effective if consumers know where to access this information. When
this point was raised with the TGA, Dr Richards advised the committee that
“this recall was published in the media as well”.
While this may be the case, the evidence provided to the committee showed that
the TGA's communication strategies are not always effective in raising
awareness with affected individuals.
The committee notes the TGA does not have a role in maintaining
individuals information and communicating with them directly about medical
devices, however also notes the efforts the TGA has undertaken in providing as
much information as possible to consumers via their website and engagement with
Based on the evidence received, the committee considers that media
reports on PIP breast implants contributed to Australian patients’ anxiety.
The committee encourages the TGA to continue to issue regular alerts
regarding PIP breast implants, and include in these updates information about
what the TGA is currently investigating further. The committee suggests the CMO
issue frequent media releases regarding the PIP breast implants situation,
providing the most current advice, a summary of the facts and what further
testing is being undertaken to facilitate accurate media coverage on this
Lack of support from surgeons
In addition to the lack of notification from surgeons about the issues
with PIP breast implants, the committee also heard evidence regarding a lack of
support from some surgeons and, in some instances, inappropriate responses from
surgeons when patients tried to seek further information about their implants.
One woman shared with the committee her experience of contacting the surgery to
seek more information only to be told the surgery did not use PIP implants.
When I called my surgeon to ask them about my implants, as I
had a small card stating that I indeed had PIP implants, they denied ever using
them at their clinic. It was after much arguing with them that they agreed that
I did in fact have these implants in my body as I had the Identification card
in my hand.
Others submitters spoke of contacting their surgeons and being made to
feel as if they were overreacting.
They made me feel as though I had done something wrong and
that I was wasting their time with my phone call. When I got off the phone I
could not stop crying, I did not call them because I was angry, I called them
for advice and support...
They told me I was being stupid and irrational and there was
no cause for concern, while shooing me out the door they gave me an information
sheet regarding the bankruptcy and concerns of the PIP implants.
Some patients actively sought information from both government
information sites as well as from their surgeons. The evidence received
reflected frustration when women were directed back to their medical
practitioner. Submitters explained that there seemed to be no one taking
ownership of the issue:
I was disappointed to have to hear about the PIP implants
issue through the media and not to be contacted by my doctor personally to be
advised. I become aware of it in December and of course was extremely
concerned. I immediately contacted my surgeon to be advised [their] records
detailed I had PIP implants. I was emailed the government link and advised the
media was over reacting, and if I was concerned to contact my local GP.
...I question that the TGA, the government and the surgeons
themselves would not feel it is fit to inform people as a mandatory course of
action when something like this happens. I have also been shocked by the
surgery’s “nothing to do with us” attitude about the faulty goods supplied.
The committee heard evidence from Dr Fleming about what the process is
for surgeons when these concerns are raised with them:
The first thing is that the patients must have access to the
doctors; they must not be fobbed off. They need to be seen for a consultation
or, if they live in a far-distant place, they need to have a rapid telephone
consultation with the doctor. In the first instance, having had the specific
conversation with the patient, we would direct them to the video series. There
is information there which is factual, understandable and evidence based. Our
experience has been that if patients watch the video series their anxiety
levels are substantially abated. Nobody is saying there is not a potential
problem with PIP implants. We would then recommend the patient have an MRI
scan—that is why the Medicare rebate is so important—to see whether the implant
Both the plastic surgeons and cosmetic surgery bodies, the ASPS and ACCS
respectively, have codes of practice for their members that set out guidelines
for ethical practice and achieving the highest quality of patient care. Both
codes refer to members having to undertake their medical practice in a
client-centred manner. In regards to adverse events or complications, the ASPS
code specifies the following:
If the patient suffers an adverse event, or has an outcome
that is less favourable than expected, members must provide the patient with an
open and honest explanation of what has happened. There should be no attempt to
cover up any complication or medical error.
The ASPS code states that any person may bring a complaint against an
ASPS member and that complaints must be made in writing and anonymous
complaints will not be accepted.
The ACCS code of practice reflects their members must "practice
with integrity and honour, in the best interests of their patients, and with
the patient's safety and quality of care being paramount."
This code also sets out that members need to provide "full and
adequate" post-operative care, and sets out a detailed complaints process
for consumers should the care not be appropriate. This process also stipulates
complaints must be in writing.
Based on the evidence received regarding PIP breast implants, the
committee is very concerned that some medical practitioners have not
appropriately responded to patients when approached to provide information and
support in light of issues with PIP breast implants. The committee views
medical practitioners simply referring patients to a national information line
as being an unacceptable response.
The committee encourages women who have felt mistreated by their medical
practitioners to lodge complaints as per the processes outlined in the
professional codes of practice.
The committee also encourages the Chief Medical Officer to write to
medical practitioners that have been known to use PIP breast implants across
Australia reminding them of their obligations under their professional codes of
practice and to provide accurate information to women with PIP breast implants.
The committee is also of the view that it would be useful for the TGA to
raise awareness among both the public and medical professionals about the
provision of appropriate information relating to medical devices. The TGA, through
the CMO, should also consider whether it is relevant to require medical
practitioners to provide comprehensive written information to patients about
the device they have been implanted with, and whether the TGA or other relevant
body should impress on patients the importance of having this information in
case of recall. The committee considers an increased emphasis on consumer education
in health could have resulted in better outcomes for affected women in this
instance. Consumers that are educated and aware of the services and treatments
available to them, as well as their potential implications are more likely to
make fully informed decisions and to recognise any issues before they are
Inability to access MRI facilities
In order to accurately evaluate the integrity of PIP breast implants, an
MRI scan needs to be undertaken and the MRI machine requires a breast coil to
undertake this evaluation.
The committee understands that not all Australian women have access to
the necessary MRI machines with the breast coil to assess whether their
implants have ruptured and require removal. When asked if these machines with
breast coils were easily accessible all across Australia, Mr Bartlett from the
Department of Health and Ageing advised the committee that:
They are reasonably accessible all across Australia. I think
it is fair to say that MRIs are not distributed right across the country. You
find considerably more in metropolitan areas than you do in regional.
CHAIR: What about northern Australia?
Mr Bartlett: I think there is an MRI machine in
Senator MOORE: With a breast coil?
Mr Bartlett: I could not tell you that for sure, I
would have to check the map as well.
According to the list of diagnostic imaging practices that provide
breast MRI service there are a number of MRI machines with this breast coil
throughout Australia in both regional and metropolitan areas. However, at the
time of taking evidence for this inquiry, there were no breast coil facilities
available in the Northern Territory which means patients in northern Australia
cannot access these facilities.
The Department of Health and Ageing advised the committee:
The Northern Territory has one Medicare-eligible MRI unit
located at Royal Darwin Hospital. This unit has recently procured a breast coil
and will be accepting PIP patients from 5 June 2012.
The committee believes readily accessible MRI facilities throughout
Australia are critical. It is noted that current MRI breast coil machines are
spread fairly widely across Australia, however the committee was disappointed
that patients in the Northern Territory did not have access to breast coils in
order to assess whether a rupture has occurred when the product was recalled.
The committee is pleased that this facility will now be available to affected
women in the NT in June 2012.
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