Annex: summary note on the Health Committee
web forum on PIP breast implants
Introduction
1. Following the conclusion of its inquiry into
PIP Breast implants and regulation of cosmetic interventions,
the Health Committee set up a web forum to hear first-hand from
women who have breast implants which were manufactured by the
French company Poly Implant Prothèse (PIP). The purpose
of the forum was to gather first-hand information about the scale
of the problem and how well it is being tackled. Participants
were asked to contribute their personal experiences of implant
surgery from a private provider or the NHS, and how far their
particular concerns about implants had been addressed where they
have sought to raise them.
Practicalities
2. The forum opened on 2 May 2012 and was closed
to new comments on 31 May 2012. By 24 June 2012 the forum had
received over 4,230 page views.
3. The site was designed and created by the Parliamentary
Web and Intranet Service. During the registration process, users
agreed to a set of discussion rules. The forum was moderated by
Health Committee staff. Messages were checked to ensure that they
adhered to the discussion rules before they were published on
the forum.
Outreach
4. The forum was announced by the Committee via
a press notice. The Web and Intranet Service publicised the forum
via social media outlets including Facebook and Twitter. Parliamentary
Outreach also promoted the forum to their contact base. Analysis
of the data on referrals to the web forum indicates that a substantial
proportion of registered contributors and visitors to the forum
found it through following links from PIP support groups established
on Facebook.
Forum questions
5. Participants in the forum were asked to address
the following questions:
- How did you first learn of
the potential issues with PIP implants?
- If you have, or think you may have, PIP implants,
have you experienced problems with them?
- What advice did you receive before or at the
time you received your implants?
- Have you sought to have your PIP implants removed
or replaced? If so, what has your experience been?
6. Following the publication on 15 May 2012 of
the response to the Health Committee's report on PIP Breast implants
and regulation of cosmetic interventions and the report of Earl
Howe's Review of the actions of the Medicines and Healthcare products
Regulatory Agency (MHRA) and the Department of Health, a further
question for response was added to the site:
- What do you think of the Government's
response to the Health Committee's report on PIP breast implants?
Profile of respondents
7. 194 women registered with the forum and left
279 posts. All the registered contributors had received breast
implants: 189 women had received PIP implants and the remainder
did not know what implants they had. 187 women had received their
implants from private clinics: the remaining seven had received
them from the NHS (five in England, one in Scotland and one in
Northern Ireland).
8. Registered contributors to the forum received
their implants in the following years:
| Year
| Number of contributors
|
| 1992-2003 |
21 |
| 2004 | 46
|
| 2005 | 20
|
| 2006 | 29
|
| 2007 | 22
|
| 2008 | 37
|
| 2009 | 14
|
| 2010 | 5
|
Summary of responses
A summary of responses under each topic is given below. In some
cases the responses have been edited for clarity. Names of identifiable
clinics or medical groups have been edited from this summary.
The full text of each response is available on the forum website
at http://forums.parliament.uk/pip-implants.[9]
A. How did you first learn of the potential
issues with PIP implants?
9. Contributors were asked to respond to the question above
and the following sub-questions on the topic:[10]
- When did you first discover that concerns had been raised
about these implants?
- Did you receive any contact from the NHS or your
clinic informing you of concerns about PIP implants?
- If you raised concerns with the NHS or your clinic
about these implants, what response did you receive?
- How do you feel about the contact you have had
with the NHS or with your clinic about issues with PIP implants?
Notification and communication
10. Several respondents discovered that the implant
type they had been provided with had been the subject of a medical
device alert, and had been subject to recall by the French medical
device regulator, via the media rather than by their provider:
"I learnt about problems with PIP implants
from the BBC news around Christmas 2011. I only received a letter
from the company about 6 weeks after the story broke. It only
told me that I had PIP implants and they would be in touch. They
later told me I could go for an MRI scan in Plymouth or Republic
of Ireland (I live in the Isle of Man!). I didn't bother replying."
"I first heard about the problem with PIPs
just before Christmas 2011. I was worried sick and very upset.
On phoning my clinic they seemed to dismiss my concerns and said
there was no link with cancer as if this was the only thing that
would cause any concern. I received a standard letter from the
clinic several weeks later which just said that they would be
in touch shortly and to keep checking their website and [the]
MHRA website for updates. They set up a PIP helpline but this
was answered by people at a call centre who had very very little
knowledge of PIP implants, they seemed to be reading and quoting
automatic responses from a sheet and always said that someone
would call back from my clinic when available. The clinic later
sent confirmation I had PIP implants. Then a couple of weeks later
they said I would need an MRI scan at my own expense to see if
I had a rupture in either or both implants."
"My email and home address and phone number
have not changed since my operation, yet I received no notification
of the health scare with PIPs from my provider, it wasn't until
I saw it on national TV in January [2012] that I thought it may
possibly relate to me. The clinic have been less than sympathetic
and the emails that I have received since have resembled disclaimers
rather than attempts to rectify a difficult situation."
"[I] only learnt about the scare in January
2012 after seeing a short news report. When asked for implant
type advice from clinic they took 4 weeks to respond and said
I had PIPs, but ok ones as [they were manufactured] pre 2001.
On March 15th [. . .] MHRA stated pre 2001 [implants were] also
affected - I'm still waiting to hear this news from the clinic
I used."
"I first heard about this in Dec 2011 but
to be honest I didn't think it concerned me: I just presumed it
was people that went abroad for cheap operations etc. I went to
a massive cosmetic surgery group and had very lengthy discussions
with my surgeon to ensure I had the best possible silicone that
could not leak in to my body. He assured me that there was no
better/safer option and even swayed me away from going with another
implant as he thought this one was safer! In Jan [2012] I went
to get my hair done and got talking to a lady that revealed that
she had had her implants done at the same clinic as me and that
she had had them removed as they were PIP and ruptured. I called
the clinic straight away to ask them, they told me it would take
a few weeks (longest weeks of my life) they phoned me to inform
me that I had and that I would be seen within 8 days. It's now
been 3 months and I have still not been seen!"
"It was in the New Year [2012]. I had heard
about the PIP Implants, but wasn't worried as I had cohesive implants
and I hadn't heard of PIPs. But I did look for any paperwork and
I found the card that the hospital gave me and it said PIPs. I
was very worried and called my clinic. I was told to leave my
contact details and someone would get back to me. After 2 weeks
I had heard nothing, so I called again, and was told that an appointment
would take weeks to see the clinic. By calling as pretending to
be a new patient I got an appointment at the clinic for a week
later. To this day the clinic has still not given me anything
that says that I have pips (I have had them removed so I know
I had them)."
"I first discovered when the news broke
in December that French authorities had recommended removal of
PIP implants. I received no contact from the NHS or my clinic
at all. The response from the NHS was confused: GPs were ill informed
and confused as to what they are able to do and told me to go
to the private clinic. I am disappointed about the response from
the NHS and private clinics. I feel like I am stuck in the middle
with nobody willing to take responsibility to help me."
"I first knew something about them in Jan
2012 when I heard it on the news, didn't think anything of it
till someone told me the bigger picture so [I] decided to look
into it myself. I didn't receive anything from [the clinic]."
B. If you have, or think you
may have, PIP implants, have you experienced problems with them?
11. Contributors were asked to respond to the
question above and the following sub-questions on the topic:[11]
- When did you first discover
that concerns had been raised about these implants?
- Did you receive any contact from the NHS or your
clinic informing you of concerns about PIP implants?
- If you raised concerns with the NHS or your clinic
about these implants, what response did you receive?
- How do you feel about the contact you have had
with the NHS or with your clinic about issues with PIP implants?
Medical issues
12. Respondents reported a number of symptoms
which they attributed to PIP implants: in many cases they reported
that the removal of the implants correlated with a lessening or
disappearance of the symptoms.
"I have been telling my GP for the last
2 years that I have lumps and pains in my armpits and shooting
pains down my arms. My GP said it will be nerves in my neck. I
also went with massive shooting pains in the sides of both breasts
and I was again told this was back trouble. Since the PIP scandal
broke I went back: he again examined my breasts and I was told
that they do in fact look misshapen and flat, one bigger than
the other and with obvious ripples. I was eventually referred
for an MRI [scan] which has confirmed that I have folds in the
implant and prominent axillary [lymph] nodes."
"I had noticed that my breasts had changed
over the last year or so. I thought this was just down to the
ageing process as I had them in for 8 years. Around Christmas
I began to experience burning pains in the left side, which got
worse during the night and when I got up in the morning, gradually
wearing off as the day progressed. After discovering they were
PIP implants, I really noticed that their shape had changed considerably.
[ . . . ] I had my implants replaced at the end of March, where
it was found that the left was in fact ruptured. The pain I was
experiencing disappeared as soon as they were replaced, so I have
no doubt that it was caused by the PIP implant rupture."
"I had my PIP implants in 2006 [. . .].
The first I heard about it was on the news in December last year.
I had my implants removed earlier in the year which I paid for
myself, they had both leaked. I have suffered health problems
ever since they were put in including, tiredness, underactive
thyroid, anaemia, pain in head and chest, breathing problems,
swollen glands for 2 years, bleeding gums. The list is endless.
I have been referred to many consultants who have been unable
to find the cause obviously as there is no test for silicone in
the body."
"I have [a] confirmed rupture in my left
breast, I also have a fluid around my right. I have experienced
burning, change in size, lumps in lymph nodes, pins and needles
and dull aches in my arms."
"[I have had] pain for years in left abdomen,
shoulder and upper back, raised lymph nodes underarm, (all on
left hand side) chronic fatigue, unable to think clearly and anxiety.
I found out upon explanting that I had a gel bleed in the left
and am still suffering symptoms even after explant and not replacing
as it is now in my system."
"I have had problems following removal
of my ruptured PIP implants in February 2012. It appears that
it is not a straightforward procedure as there are risks of further
leakage of the silicone. I had silicone in my lymph nodes prior
to removal of these implants, however I know have more lymph nodes
affected following the explant surgery. I have pain and discomfort
daily and I am currently still under the care of the NHS Breast
Clinic. I will need surgery to remove these lymph nodes but there
are risks to having this surgery, especially with regards to the
larger nodes that are currently affected. I may experience breast
oedema and lymphoedema in my right arm. I am very anxious about
this and I have not made a decision yet as to whether or not to
go ahead with this surgery. But I am also not happy with having
to continue taking painkillers daily to cover the pain that I
experience every day."
"I have PIP implants with serial numbers
matching the recalled batches. Problems experienced are burning,
tingling sensation and spontaneous sharp pains or throbbing. Noticed
end 2010. Private clinic refused to acknowledge any link between
symptoms and PIP; no evidence. Also said no evidence to suggest
routine removal. If however I wanted my implants removed (PIP
word never mentioned) then surgeon would remove under LA [local
anaesthetic] only at normal cost. Surgeon felt he had no liability
as implants were MHRA approved."
"2 years after PIP implants I suffered
joint pains to knees and elbow, anxiety attacks, hair loss, sensitive
eyes, weak knees [and I was] spaced out [and] feeling unbalanced:
the list is endless. I found out I had PIPs as I started to Google
my symptoms as all blood tests showed negative but I knew something
was wrong with me and stumbled against [the] PIP scandal. I had
them removed and not replaced at [my] own expense as [I was] convinced
[my problems were] linked to implants, and [the] joint pains disappeared
within 2 weeks and [the] hair loss recovered. Unfortunately other
symptoms [are] still continuing. My implants had not ruptured
but I believe they sweated/bled."
"I have never incurred pain with the implants
as other women have but I knew something was wrong [in] mid-2011,
as I noticed my right breast seemed to be getting larger. Over
the last few months since I noticed this I have suffered hot sweats
and tingling/cramps sensations - but prior to the scandal coming
out I never put these issues down to the implants [ . . . ] I
now have had confirmation of internal and external ruptures and
silicone laden nodes in my right axilla. I do now very much believe
my sensations/cramps are due to the implants."
"I have recently found out I have PIP implants
as I was experiencing horrendous pain in my chest, arms, neck
and head. [ . . . ] I am now on the NHS waiting list for my scan
which at the earliest will be in July - almost 2 months after
I started experiencing the pain. I am in agony taking codeine
prescribed from my doctor.
My health, family and working life are suffering greatly and I
can't seem to get any support from anyone. [ . . . ] I have been
told unless [my implants] have ruptured they will not be getting
removed and replaced even though they are causing me such bad
pain and anguish and are now majorly misshaped not to mention
the impact it's having on my health."
"After I had the implants I started feeling
tired all the time, pains in my muscles, cysts in my ovaries and
breast, stomach problems, [a] poor immune system, dark brown discharge
from [the] nipple, burning breast, memory loss.
My GP is lost with all of my symptoms: he has done blood test
after blood test. I have had X-rays taken to check my bones and
operations to remove cysts. I was sent to a cancer ward for an
ultrasound [scan] over [a] lump in [my] breast and the discharge.
All this has been going on for years. I am now 34 years old and
my body feels like an old woman. Only eight months ago I was diagnosed
with fibromyalgia. I feel that my implants have played a big part
in all my illness. I have never been the same since."
13. Reports of responses from private clinics
were generally not positive:
"I heard about PIP implants on the news
in December 2011 but to be honest I didn't take much notice as
I knew these were cheap implants and because I had gone to a top
surgeon and paid 'top' money for them, I assumed he wouldn't have
used these. It was only in early January that I was urged by a
friend to look at the surgeon's website and on it I saw he'd put
a comment about PIP implants. I contacted his office and after
about a week I received confirmation that I did have PIPs. Prior
to me finding out, the clinic had not been in touch with me to
advise me that I had PIPs and I'm sure they never would have as
I heard they have themselves found out early last year and had
put their company into liquidation to prevent them from this scandal
leaking out. I was told by the clinic not to worry, but that I
should pay to have them removed and replaced at a cost of £3,900.
I am appalled and disgusted that they didn't have the decency
to contact everyone involved at the time, rather than each individual
having to contact them to find out the devastating news. I am
then appalled that they didn't have the decency to deal with everyone
involved, rather than some cases that they deemed suitable (i.e.
less than 10 years old)."
"I first heard about PIP implants on the
news in December [2012]. My clinic did not inform me of the recall
in 2010 and failed to mention this on my 5 year check up after
the recall for which they said there was no issue with my boobs
even though they were sagging/misshapen. I did not think I would
have PIP implants as I went to a top clinic and paid a lot of
money but I phoned to check to be on the safe side on 23rd December.
At first she said 'oh, we hardly used those implants, don't worry',
so I was relieved. I then got a phone call a couple of days later
which I could not believe telling me that I had them and they
only used them on 50 people [. . .]. They also said the MHRA [had]
said there is nothing to worry about and it's all media hype.
I was crying on the phone and she said I should have them replaced
and it would cost £4000! She offered no help whatsoever and
was very rude and short and did not reply to my emails or phone
calls. It took me a month to get my records and also a letter
from them confirming the situation."
14. Women who approached GPs for referrals to
NHS services reported mixed experiences:
"I also went to my GP who I have to say
was very good (and this was April 2010 before people were made
more aware [of] this). He referred me to the (NHS) breast clinic.
The breast clinic saw me very quickly and tried to reassure me.
They said the pain would be due to hormones (even though I've
never had this problem pre implants). They asked me where the
most pain was and they scanned that very small area on the right
breast and said it was fine. ([I] since found out the left was
leaking silicone, the one that wasn't checked)."
"I went to see my GP who was lovely and
very sympathetic. I was referred to [the NHS] breast clinic. My
experience there was very different. They were horrible to me.
They told me I should take problems up with clinic not them and
that they were there for women with breast cancer symptoms implying
I was taking [a] valuable appointment away from a cancer patient.
I was refused a scan at first but on examination I had some slight
thickening on left side so had an ultra sound on that side but
only an area the size of a 50p. I was kept waiting three hours
at the clinic and found them very rude. I ended up paying privately
for an MRI scan."
"I was that disgusted with the lack of
response from the private company who put my PIP implants in initially,
I refused to go back to them. I raised the problem of having the
PIP implants with my GP who referred me to the breast clinic at
the hospital. I received an appointment for a consultation with
a surgeon 3 weeks later. I had an ultrasound exam at that appointment
which confirmed ruptures in both breast implants. The surgeon
told me I would have to pay privately to have implants put back
in, though she could remove them only on the NHS if I wanted that.
I was very pleased with the response from the NHS."
"I contacted my clinic about these health
issues only to find they had gone bust!
So I contacted the hospital where I had it done, they arranged
a consultation for me to see the surgeon who done my operation.
The surgeon was very abrupt and rude and told me to go back to
my clinic as it was not his problem. He also stated that he had
no moral duty towards me. I then approached my GP who sent me
to see a NHS breast consultant at my local breast clinic. The
consultant arranged an ultrasound for me which showed nothing,
so I asked for an MRI scan but was refused on the grounds of not
worth spending the money."
"My GP was helpful but every time I was
referred for a scan the NHS breast clinic refused to see me even
though I had pain and lumps in my breasts. I don't blame the NHS
for refusing to see me. But [the Secretary of State] shouldn't
promise the public we are being helped when he knows we are being
turned away. I have a letter proving they refused to see me [.
. .] I am appalled that the Government did not support us and
make the clinics face their duty of care to us. It is shocking
that we have been left like this."
"I have lumps in my breast, hardening,
pain and tenderness, I am suffering from extreme tiredness. I
have raised [this] with my private clinic who were only willing
to help if I paid another £2500 and £500 for a scan.
I approached my GP who said I had to take it up with the clinic.
I feel very worried that I have nowhere I can turn to, I cannot
afford another £2500 to replace my implants, I feel the clinics
are in a difficult position: because the government has not declared
PIPs unsafe, the clinics cannot claim on their insurance and offer
replacement, the NHS won't replace and the women who are victims
are stuck in the middle."
"I had not experienced problems with my implants,
but I raised the issue of a scan and replacements with my original
clinic and my GP and neither wished to help me. I feel I hit a
brick wall, and that nobody cared about the situation nor wanted
to help me find a solution. I felt judged and that people saw
it as a risk that I had taken and should have expected there to
be a problem."
"When I went to see my GP I was almost laughed
at and rather rudely asked questions that were very upsetting.
I had to save up to go private as the NHS funding I was meant
to [have] got was pulled. I had to explain all my circumstances
and, finally, as I had been under the GP for nearly a year with
different problems that could [have] been down to the PIPs, they
agreed to refer me for a scan. After weeks of waiting I got a
call from the GP saying the hospital refused to scan me. In tears
I had to go through it all again: the GP refused to do anything.
Eventually later that day the GP called me again and told me she
would refer me to plastics and they could decide what to do. I
did eventually get an appointment with plastics who then put me
forward to have a ultrasound scan."
"My female GP has been supportive but sent me
to a breast unit in March 2011. It was embarrassing to be there.
Understandably breast oncology surgeons have cancer patients to
treat. Said I had nothing to worry about and that my breasts shape
were just fine [. . .] [that was] not the reason I was there,
the PIP matter seemed to be completely ignored or they seemed
unaware of it. As more info was released as well as [the] NHS
support offer, I returned to my GP Jan 2012. I was referred to
[the] plastic [surgery] unit and sympathetically treated although
I feel uncomfortable having to ask for NHS support. I do not want
replacement implant[s]. Surgery was scheduled and twice withdrawn
due to bed shortage. The third booking went ahead for bilateral
PIP explantation and capsulectomy. Treatment and care was outstanding,
far better than I would have received at my private clinic even
if they had agreed to explant. I am supremely grateful."
"When I went to the GP, I was sent to [a] cancer
doctor as [I was] told [that] implants could not rupture. After
having a biopsy and finding silicone in my lymph nodes, [I] wasn't
happy at all when [I was] told they could not rupture, and [I]
had to beg for [an MRI scan] to prove they had. [I] also had to
wait another 6 months to have them removed, then needed another
operation to remove more lymph nodes full of silicone. [I am]
constantly being told not to stress and read info on internet.
[I have been] very unhappy with [my] experience."
C. What advice did you receive
before or at the time you received your implants?
15. Contributors were asked to respond to the
question above and the following sub-questions on the topic:[12]
- What information were you given
about the type of implant you were receiving?
- Were you told about any risks with your implants
in general or about the particular implant type you were receiving?
- What information were you given about aftercare?
Were you made aware of the general risks of implants reaching
the end of their life span?
- If your care provider was a private clinic:
- what promotional information
and marketing was used to tell you about the surgical procedure
and the implants you would receive?
- what medical information did you receive about
the surgical procedure, the risks of rupture of breast implants
and the need for eventual replacement of your implants?
Information about type of implants
16. Few of the women who responded had been given
information about the manufacturer of their implants, either before
or after their operation:
"At the time, I was not given ANY information
about the type of implant, apart from the fact it was silicone.
I saw one and was allowed to touch it."
"I was also never advised on the brand of implant,
it was sold by [the clinic] as a generic cohesive silicone implant
which was known to be very safe and would last for 10-15 years
or more. The manufacturer was not mentioned until I received my
post op card."
"I was only told that they used silicone implants.
I was given one to hold and was given a tight fitting t-shirt
to put on and try a few different sized implants to decide on
a size."
"I was not told (did not think to ask) what
type of implants I would be getting.
To be honest I would not have been any the wiser had he told me
I was having PIPs. I was unaware that there different types."
"I was given no information about the brand
of implant, nor any choice on the type of implant I was having.
I asked why the clinic I was going with was several hundred pounds
more than other clinics I had visited. The nurse looked me in
the eyes and said 'we use the best products and we will give you
the best aftercare. When you are our patient we look after you.'
That is why I decided to go with them."
"All [the clinic] told me was that they were
silicone implants. I didn't see one or anything, they didn't even
tell me what make or size or anything . . . . but then again why
would I ask . . . . I went to a highly recommended surgeon and
clinic which [was] more expense to me. I paid for the best . .
. ."
"When I went for my consultation with [the clinic],
they showed me, what they called 'the best silicone implant on
the market', and told me that they very rarely rupture, and if
they ever did, which would usually be because of impact, they
stay within the capsule. To demonstrate this they showed me an
implant that had been cut in two. The nurse at [the clinic] told
me that she could see no reason why I wouldn't take these implants
to my grave as they were so good. I now know this was untrue as
one of mine had ruptured after only 6 years."
"I was given no information prior to surgery
other than that I was getting a top of the range recommended implant
that would last me around 20 years."
"[I] was assured that implants never need to
be replaced - not like years ago when you would have to change
them every 5 or so years - these were the top of the top and were
super duper great!!"
"I was told that the pip implants were the safest
and most durable. I was not given a choice: the surgeon said it's
all he ever used."
"My surgeon told me that PIPs were the best
and most expensive available and that they should last a lifetime.
I was shown cohesive implants and was told how safe they were."
"I was told I'd be having silicone gel implants
and the make PIP, and that they were the best on the market."
17. Several women reported similar themes used
by clinics addressing the risk of rupture in cohesive silicone
implants:
"I was told they were silicon cohesive gel and
could not leak or break. I was told the result would most likely
be permanent should there be no problems such as hardening."
"I was also told the cohesive gel in the implants
was like a 'Gummi bear'. In the very rare chance - which would
need to be a car accident - that these implants ruptured the gel
could not go anywhere because of this consistency."
"[I] did not receive any advice from [my clinic]
when I had the PIP implants, only that the PIP implants would
last a lifetime, it would take a high impact car crash to rupture
them."
"[I was told] that you could drive a car over
them and they still would not rupture."
"I was told they were completely safe and because
of their cohesive nature even if they did rupture the implant
would retain its shape because of the gel like consistency of
the silicone. An implant was cut in front of my eyes to demonstrate
how the gel retained its shape."
"I was told that my PIP implants would never
leak, and the shell would only rupture if I were in a car or plane
accident, or stabbed."
"I was told that my implants were top quality
and had a rare rupture rate & if they ever did rupture, it
would be because of a very forceful impact, like a car crash,
and even if this did happen, the silicone would not leak into
my body because of the cohesive gel. They told me it was like
cutting open a jelly baby."
"I was shown an implant and given a demonstration
of how strong they were. In was told about their outer shell and
how they were medical grade silicone. I was reassured that even
if they did rupture they would stay enclosed in the outer shell
and would not leak into my body."
"I was also given a demonstration of the texture
and the contents - an implant was cut in half and resembled that
of a 'jelly baby'. This was to demonstrate how difficult it would
be for them to rupture and that there was no possibility of the
contents leaking out as the texture was not liquid form."
"All I was told is that my implants would last
20 years and they were the best on the market and if [they were]
to rupture they were like a jelly baby so wouldn't leak into my
body."
"I was told that the implants were the safest
you could get, that if you cut them they were like a 'jelly baby'
that they would not leak. I was never told about any other implants,
these were the only type they told me about."
18. Some contributors had been persuaded of the
benefits of silicone gel implants over saline implants:
"I asked my surgeon for saline implants as I
was terrified of them leaking and silicone getting in to my body.
The surgeon told me that saline had not been around that long
and in 20 years side effects may come to light that we do not
know about. He convinced me that silicone was best and especially
the more expensive cohesive silicone, impossible to leak; he even
cut one in half and showed me, demonstrated squeezing it and told
me and my husband to squeeze it as hard as we could and the gel
just oozed out and then sprung back in to the casing."
"I went to my clinic asking for saline implants
but they talked me into silicone as they said they were SAFER!"
19. Some women using private clinics recalled
the medical information they had received about the surgical procedure,
the risks of rupture of breast implants and the need for eventual
replacement of their implants, though the information given seems
to have varied from case to case:
"I was given limited information re problems
and potential re operations. Aftercare was 3 years, and I was
told [that the implants were] that good it would be 15 years before
needing [to be] replaced. [ . . . ] No promotional info [was]
ever used to tell me about the implant/surgical procedure. [The]
medical info was concentrated more on the risk of a general anaesthetic.
I was told the chance of rupture was minimal; it would take a
high impact car crash for example to cause them to rupture. They
kinda glossed over this area to be honest."
"My surgeon told me [that my implants] may need
to be changed in the next 15 years but only if the need was there,
such as hardening of the capsule, but that was very rare."
"I was not given any promotional deal or marketing
gimmicks (apart from to try them under some clothes to see the
look, which obviously will sway a girl's opinion!) I have the
PIP information leaflet for both surgeon and patient. I have all
the associated risks with normal implant surgery, I was told rupture
was rare and that these particular implants were strong and almost
impossible to rupture which was why they were a good brand and
that replacement, although on average is 16.4 years, is not necessary
if you have no problems and they are still relatively soft."
"The sales advisor, who was also my surgery
co-ordinator, showed us the product and the brochure which was
given to me, this has no implant branding in it. I did my own
homework about my surgeon but not about the implants themselves.
I had no idea what size was being put inside me: [the sales advisor]
did not discuss this with me; he just asked me my ideal cup size.
He did not discuss aftercare with me, that was discussed after
the op with a nurse on discharge or I presume she was a nurse
as I was not told. I was told to leave the hospital at 7 am even
though I was feeling unwell and had had my operation at 6pm the
previous day, I had nothing to eat the whole time I was there
and nothing was offered which is probably why I was feeling so
ill. The aftercare was poor and nonexistent. I missed my two week
follow up due to falling extremely ill from a canular infection
from the operation. I never had a call from the clinic at all:
I had to call them to arrange another appointment. I have not
seen my surgeon after my operation or on the operation day, the
only time I have actually seen him was for the 20 minutes he was
selling me [the breast augmentation]."
"I was told all the general risks of implants
i.e. rippling, breast sensation loss, pregnancy, weight gain and
loss, capsular contraction and sagging, [and] that the gel does
not ooze if ruptured [ . . . ] On aftercare I was given a instruction
sheet of what to do and avoid. I was given an on call number,
I was given an appointment 14 days after surgery and then another
3 weeks after. I was told [my implants] had a life span of 15
to 20 years and a long history of reliable use. I was given brochures
to tell me about surgical procedures, and was given a sheet stating
documentaries featuring their companies, i.e. on ITV1 and Sky
Discovery Health: my surgeon actually featured in this."
"I was given information concerning capsular
contracture and was told that the only way that PIPs would rupture
would be if you were in a very severe car accident or were stabbed
in the breast, and even then that the cohesive gel would remain
together [. . . ] I wasn't given any information about aftercare
other than the type you would expect following any surgery. There
was no information about the implants regarding risks reaching
the end of their life as that would have negated all the other
things I was told."
"I was told the implants were silicone and textured.
No brand was discussed or even mentioned. I knew why [the] surgeon
liked textured but had no idea of the brand choice he had or the
reason for his choice. Verbal advice to wear a sports bra and
to refrain from lifting heavy objects and to take it easy. No
information on risks of implants in general was given. No mention
was made of life span.
No promotional material was provided."
"I wasn't given an info about rupture risks
or alternative info: this section is unsigned in my paperwork
which I've seen for the first time two weeks ago."
"[I was given] no [medical] information, [and
was] only told about incision type."
"I was told the life span was 15-20 years but
they would only need changing for the appearance as sagging may
occur overtime. I was also told these implants would be safe to
leave in if I wasn't bothered about the sagginess! [I received]
no medical information about the surgical procedure. [I was told
that there were] no risks to them rupturing: [I could] replace
if I wanted to in 15-20 years but could leave in."
"I was told that my implants could stay in me
forever. They said that after 10 years my body may have changed
and I may want new implants to suit my changing shape but that
they could stay inside me my whole life. I was given a booklet
with minimal information and was told verbally about the slight
risk of capsular contraction and rupture but was told that the
chance of rupture was tiny. They also explained I may have a loss
of sensation."
"I was informed of issues such as capsular contraction
and rippling, and the risks of elective surgery. I researched
all other risks myself. Aftercare was to massage my implants for
5 minutes daily and to wear a sports bra as I slept. Also to always
wear a bra throughout the day. I was told that the implants may
last 10 or 15 years before needing replacing, or maybe 20 years,
and may never need replacing. I was not told of signs to look
out for that may indicate the implants needed replacing. I was
hopeful I may go 15 years before needing to consider more surgery.
[ . . . ] The surgeon discussed the procedure with me and what
to expect in terms of the operation and recovery time. I was not
given any statistics regarding rupture rates, but told that it
would be trauma or impact that may cause a rupture and even if
it did, that the silicone would not leak from the shell."
"Plenty [of advice] about the risks of anaesthetic
and risk of infection, capsular contraction etc but was assured
that implants never need to be replaced."
D. Have you sought to have
your PIP implants removed or replaced? If so, what has your experience
been?
20. Contributors were asked to respond to the
question above and the following sub-questions on the topic:[13]
- If your implants were provided
by a private clinic, what response did you receive?
- If your implants were provided by the NHS, what
has your experience of NHS treatment for removal been?
- Have you sought removal and/or replacement because
you have experienced problems with your implants?
- Have you had PIP implants both removed and replaced?
If so, was it in a single operation or two operations?
- How do you feel about the treatment you have
received? Is there anything you think could or should have been
done differently?
Treatment by private clinics
21. Several contributors were not impressed by
the way their cases had been handled by private clinics:
"My private clinic have been totally useless
unless rupture is proven at my/NHS expense, after many months
in total distress I am now booked in to have these pips removed
and this time replaced at a greater expense that I originally
paid."
"I decided not to go back to the private company
who had put the implants in, because of their complete lack of
response at first to the problem in general. They were more concerned
with profit than women's' safety."
"My Implants were provided by a private clinic,
who have behaved appallingly, it took weeks for them to respond
to any emails, even though I knew I had PIPs and had 4 of the
symptoms which they stated on their website. I eventually received
details of private providers of MRI scans in Surrey, when I live
in Bucks and the charges for this. I had been in contact with
my original surgeon, who told me that US [ultrasound scan] results
would be sufficient, only to be told by [the clinic] that they
would not. I had an U/S [ultrasound] and a mammogram in Dec 2011
(before the news broke) due to breast pain - all the symptoms
which [the clinic] then posted on their website, and another in
Jan 2012, both through the NHS. After both I was given a "hands
on" examination, and both times I was told that my PIPs were
intact. One consultant told me to go home and take painkillers,
the other to take Oil of Evening Primrose - but not to quote him.
I knew that these results were incorrect and have now had R&R
[removal and replacement] with a different private provider. Both
my PIPs had gel bleeds, one significantly. I had one procedure
for my R&R and am now in debt for the first time in my life.
The treatment I received from [my provider] was disgraceful. I
questioned why we had not been informed of the situation with
PIPs back in 2010, when they were instructed to by the MHRA and
their reply was "we posted the information on our website."
Now that is hardly identifying, contacting and reassuring us as
the Medical Device Notice stated. Thinking that we would all go
onto a website looking for information when NONE of us knew there
was a problem???"
"The clinic were very slow to respond. At first
they answered the phone and dismissed my concerns saying there
is no proof PIP's are unsafe/ no link with cancer. They then stopped
answering calls at the clinic and calls diverted to a call centre
where they employed useless people who quoted automated responses
and could not answer many questions as they had no knowledge of
implants whatsoever. The clinic have been appalling: they will
only help if there is evidence of a rupture (only proven by MRI
scan funded by ourselves) and only within 6 years of original
implantation. They sent out a couple of generalised letters saying
they do care and are doing all they can etc but have yet to put
their money where their mouth is."
"I had my implants provided by a private clinic
in 2001. When I heard about the PIP scandal in January this year
I contacted the provider who told me as I had had the implants
for over 10 years (10 years and 3 months to be precise!) there
was nothing he could do as they should be changed after 10 years.
This was news to me as when I had them originally done I was told
they would last c.15-20 years plus if I had no problems with them.
He then said he would remove and replace for £3,900."
"My original private clinic did not want to
know. They would not help me at all. I struggled to get my records
for a month. They tried to charge me £4K for removal and
replacement and they said it was the governments fault and they
would not replace for free even though I had a rupture. I had
a rupture so I looked for another clinic that could replace my
implants as my original clinic and the NHS could not help me.
I had my PIP implants removed and Nagor implants inserted in one
operation. My replacement clinic were very helpful and I researched
them thoroughly having received advice and talking to other women
on a Facebook support group. They put a special package together
to help PIP victims and I am very happy with the clinic I chose
and the help they gave me when no one else would. I had to get
a loan however to pay for the replacements."
"I had my surgery with one of the biggest cosmetic
groups, and felt that this was safer. I paid over £5000.
[....] When I found out about PIPS I called and emailed the clinic.
I was told that it would take 3 weeks to get my notes, in the
end it took 3 months. And it was just the handwritten notes the
consultant made in the first meeting. No mention of the word PIPs.
I had a meeting with the surgeon: I was in his office for 4 minutes.
He was brash and clearly didn't care. Other ladies had said that
he had walked out without seeing ladies before, so I was nervous.
He even made me take my top and bra off standing next to his desk,
not even the respect of behind a curtain with a nurse there. He
felt my breasts and said that there was nothing wrong with the
implants that they were safe. He then said to talk to the lady
and book for replacement at a cost of £2900. I didn't book.
I was very unhappy with their attitude towards me. [ . . . ] I
heard about a clinic that had never used PIP implants and they
were prepared to remove and replace for £1895 I had a consultation
with a surgeon and was there for an hour, he explained everything
and made me feel very safe and I trusted him. I had my surgery
8 weeks ago, both of my PIP implants were badly ruptured and I
have silicone in my lymph nodes. It's been 4 months and I have
heard nothing from my original clinic since."
"The experience is awful, desperate. The private
clinic want me to pay up to £4000, which I can't afford.
My local hospital want to remove & replace asap as I have
ruptures, but the PCT will not fund it!!! I've worked hard all
my life, paid my national insurance, & I can't get help in
my own, disgusting."
22. There were exceptions to these experiences:
"I am one of the lucky ones. My surgeon works
for [a clinic] who have treated me very well and have removed
and replaced for free."
E. What do you think of the
Government's response to the Health Committee's report on PIP
breast implants?
23. Contributors were asked to respond to the
question above and the following sub-questions on the topic.[14]
- The Government believes that
the official response to the discovery of the PIP breast implants
fraud was 'reasonable and proportionate'. Do you agree? What sort
of communication did you expect?
- The Government has not accepted the Committee's
recommendation that it should find a means to allow private patients
who have their PIP implants removed on the NHS to have a replacement
performed as part of the same operation. This affects women who
had PIP implants with private clinics who are now unable or unwilling
to remove and replace the implants. How does this affect you?
24. Responses from women with PIP implants have
not in general accepted the Government's view of the MHRA's actions:
"[The response is] reasonable and proportionate
for the government. Not in the slightest for the PIP patients.
Action should have focused on the patient as a priority rather
than where did we go wrong and which lessons were learnt. Oh of
course, there was a reasonable response for the patient. There
is no evidence other than anecdotal and health care does not act
on anecdotal. What evidence is wanted? They should not be in the
body, end of matter. Is it really a reasonable response to sit
back while we all have non-medical grade implants in a highly
regulated country. There seems to be no telling who is going to
end up with swollen lymph nodes. Reasonable and proportionate
to have to live with this uncertainty? I hope women ending up
with lymphodema are well compensated. Someone made the decision,
someone slipped up."
"I was quite interested to see Lord Howe's report,
but was rather alarmed that it seemed to be covering the backs
of everyone in the UK. What upset me was that there was no mention
of the support that had been offered to women, by way of counselling
or telephone help lines. I am still waiting for this support.
My GP is not an expert on PIP implants or what happens to your
body after they leak."
"I think we have been very let down by our current
government. The Health Committee seem to have concerns for our
health and the government sees our situation from a purely financial
point of view, avoiding any liability for itself. There has to
be a solution in England and by publicly declaring these implants
unsafe would allow women to pursue claims against their credit
cards in accordance with section 75 [of the Consumer Credit Act
1974]. Because of the defensive stance that the government is
taking, credit card companies are claiming PIPs are still fit
for purpose."
"My life and my family's life have been turned
upside down by this: it's a total mess.
The [Earl Howe] report has not helped us PIP VICTIMS in any way!"
"We have been let down by the Government. I
have a ruptured left implant, which is leaking silicone into my
body. If there is no danger from toxins in the silicone, I guess
it would be ok for me to donate blood next week. The Government
needs to 'recall' all of the PIP implants, then we will be able
to move on with removing and replacing them, at no cost to ourselves.
The Governments response to this outrage hasn't helped us at all."
"This report was very disappointing and like
many other things in this country it is all about saving money
and financial costs. It is sad and embarrassing and makes me ashamed
to be a part of it. Five other countries have taken immediate
action in support of their women - but no not the British government.
It makes me very sad. Perhaps they need to think about the possible
long term health implications for the women of this country."
"The way I see it is everyone is passing the
buck and no one wants the responsibility for this dreadful mess.
Thousands and thousands of women have been left emotionally, physically
and mentally scarred by all of this and yet there is no one helping
us. Somebody has to be held responsible and fight for us and help
us win to obtain our money back from the original surgery let
alone having to pay again for new surgery. The goods sold were
faulty and not fit to be inside humans yet there are thousands
of women still walking around with these implants in them, causing
illnesses and untold health problems that are ruining lives. The
Government have done nothing to help us victims and the all the
words are empty ones, we need action and NOW to sort this out
sooner rather than later."
25. Women eligible for the NHS offer to remove
implants are bemused by the Government's refusal to develop procedures
to allow NHS removal and private replacement in the same operation:
"I am very disappointed that they will not let
the NHS remove and pay to have implants replaced. I don't understand
what the problem is if we are paying for the replacements."
"A creative solution would be to use two surgeons
to do the same operation: one private, one NHS. But creative thinking
clearly is not an element possessed by government departments
hell-bent on financial damage limitation. We are real people with
a very real health dilemma, perhaps even a potential health timebomb.
This will not go away and requires immediate recourse."
9 This text will remain accessible at this location
until December 2013. Back
10
The posts can be read online at http://forums.parliament.uk/pip-implants/index.php?read,1,123 Back
11
The posts can be read online at http://forums.parliament.uk/pip-implants/index.php?read,1,119 Back
12
The posts can be read online at http://forums.parliament.uk/pip-implants/index.php?read,1,121 Back
13
The posts can be read online at http://forums.parliament.uk/pip-implants/index.php?read,1,117 Back
14
The posts can be read online at http://forums.parliament.uk/pip-implants/index.php?read,1,605 Back
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