THIS IS THE CASE HISTORY OF JANET
(LEAKING SILICONE BREAST IMPLANT)
Janet has been a member if SIN for almost
two years. When the Health Select Committee announced it was
planning to hold an " Inquiry into the Safety of Breast Implants
" on Thursday, 28th March 2001, SIN was able to inform Janet of
this, and so gave her an opportunity to submit her statement, which she
asked to do through SIN. On 5th March SIN faxed through to the Health Select
Committee Janet's written evidence and a covering letter from SIN. This
evidence is available for the public to read. Janet and SIN were sent complimentary
copies of the result of the Health Select Committee's Inquiry.
Why did it take
the Health Authority five years to admit an obvious case of negligence?
Why did it take
3 years before Janet received remedial medical care?
was derisory - but how much were the combined legal fees of the Legal
Aid Board and the Trusts NHS solicitors - all paid by the taxpayer?
Janet has suffered from epilepsy
all her life and has had to take strong medication to control the attacks.
In the early nineties Janet, on medical advice, underwent a double mastectomy
because of recurring painful breast lumps. She opted to have breast reconstruction
with silicone implants.
On November 22nd 1996 a neurosurgeon
fitted a "vagus nerve stimulator" with two wires attached ( 18" in length)
below her left breast containing the silicone implant . This was for the
purpose of controlling her epilepsy. During this operation the silicone
bag was punctured causing seepage into her system. Janet immediately alerted
her doctors to the fact that a painful swelling occurred within 8 weeks
of this operation. The swelling continued to increase in size.
implant was not removed until October 1999 - THREE YEARS
was ruptured. Why the delay?
Janet developed agonising pains in
all her muscles and joints which are most likely to have been caused by
the silicone seepage. She decided to take legal action beginning in
November 1996. Her legal action was finally concluded in March 2001, one
week before the Health Select Committee held their" Inquiry in
the Safety of Breast Implants"
Although Janet was far too ill to work,
she was not allowed full legal aid because her husband was working. ( Many
woman who are unable to work because of iatrogenic damage find themselves
in this predicament and are unable to pursue their right to justice with
legal aid because their husband is working, although it is the woman's
medical case!) For 29 months Janet had to pay part of her legal costs to
the Legal Aid Board. This amounted to £159.81p per month
and severely affected their household budget. Over the nearly two and
a half years period of legal action Janet paid to the Legal Aid Board £5000
Janet's case would appear to have been
extremely straight forward - an obvious case of negligent surgery, but
it was bedevilled with long, unnecessary delays, poor medical care and
Janet says that at first the surgeon
claimed he was unaware that Janet had any implants, but later had to admit
it was clearly written in her medical notes. Janet, herself, was even blamed
for not reminding the doctors of the implants as she lay on the operating
trolley being wheeled to the operating theatre!
Why was there such an unacceptable
length of time - three and a half years - before Janet had the silicone
implant removed? During this time silicone continued to seep into her system.
Her legal action appears to have been
extended unnecessarily for several years. It took, for example, 6 months
before the surgeon would release her medical notes to her solicitors. Did
he have them or were the MDU retaining them, or were the Health Authority's
solicitors holding on to them? In the meantime Janet's health and
quality of life , not to mention her peace of mind , were all deteriorating.
Eventually Janet won her legal action
and received the princely sum of £5300 in an out of court compensation
in March 2001, four and a half years after her implant was punctured.
£5000 she has already paid to the Legal Aid Board will be reimbursed.
SIN would like
to know how much her solicitors charged the Legal Aid Board for Janet's
case. How much did the Health Authority solicitors charge the NHS for their
services? SIN imagines that their combined legal fees ( all paid for by
the tax-payer) for nearly two and a half years of legal action, would be
far in excess of the measly £5300 offered to Janet. Her case was
so obviously a straightforward case of negligence, with only one doctor
involved, that it is quite disgraceful that if took four and a half years
before the Health Authority accepted negligence and settled out of court.
What a lovely money earner for the lawyers! An absolutely inexcusable
waste of public funds. SIN has been campaigning for a Victim's Compensation
Fund which should have settled Janet's case within 6 months at a fraction
of the cost. Janet - not the lawyers - should have received the money.
Janet's epilepsy is much worse, she sometimes has as many as 3 attacks
a day and this could be related to the effect of silicone in her system,
causing possible autoimmune disease; and also to the stress over the last
What were the
findings of the Health Select Committee? To read the full report with oral
evidence access the website: www.parliament.uk/commons/hsecom.htm
Perhaps it would
be relevant to make a few quotes from the Report;
" In 1994
when we first raised concerns about the then Medical Devices Directorate's
approach to the safety of silicone breast implants our correspondence was
immediately passed to the D.o.H.'s solicitor. His answer was ......" that
it is not appropriate ....to become involved in a lengthy dialogue.." Regrettably,
this refusal to delve into issues put forward by women who believe they
have suffered injuries from their silicone breast implants...has continued.....Accordingly
, no action restricting the use of silicone implants has ever been taken.
The conclusion we believe the Committee has to draw is that, as unpalatable
as it may seem, the main objective of the MDA ( Medical devices Agency)
since 1993 has been to stand by their initial view, thereby justifying
their inaction, rather than to protect and inform women contemplating undergoing
silicone breast implant surgery". page 74 para. 24 Conclusion
" It is
our understanding that the MDA has not sought adequate safety data from
the manufacturers for these products, nor attempted to impose any restrictions
on their use until data has been provided. We would remind that Committee
that in the USA, Australia and Canada manufacturers have not made any significant
attempts to re-enter the market and would respectfully suggest that the
Committee draws the inference that it is possible that the manufacturers
have doubts about the safety of their product. It is in any event clear
that the manufacturers are unable to demonstrate the safety of these products."
page 73 para.9
" We are
not convinced that the D.o.H booklet "Information for Women Considering
Breast Implants" gives sufficient information as to the risks of these
products. " page xiv para. 39
" We recommend
that the revised edition of the D.o.H booklet draws attention to those
countries banning silicone gel implants. Women contemplating this operation
are entitled to this information." page xiv para. 40 [
The countries banning silicone breast implants are: the USA, Canada and
to consent forms:
that the new consent form will encourage a more open dialogue between clinicians
and patients and will ensure that issues relating to safety and costs are
fully explored before a decision is made to proceed with surgery." page
xvii para. 52
Janet have got a higher settlement if this highly critical Report had been
Implants: Soya oil implants marketed under name of Trilucent are now
banned in the UK in March 1999 by the MDA because of fears as to their
toxicology "the products produced by the breakdown of the soya bean oil,
which are known as aldehydes, were potentially carcinogenic" On 6th June
2000, the MDA recommended the removal of Trilucent implants
as a "precautionary measure " - risks of cancer or damage to
an unborn baby could not be ruled out" page xviii paras:
55, 56 & 57
Implants: Spontaneous implant rupture resulting in local migration
of contents : 50% implants are ruptured at 12 yrs, 95% at 25 yrs.
CASE HISTORY OF JULIA
DAMAGE DURING TRAUMATIC CHILDBIRTH
Until the 39th week Julia's
baby had been lying transversely in the uterus, but had moved spontaneously
a few days before the birth started. Julia then spent three traumatic
days in labour during the birth of her second baby.
damage and trauma - yet no case
minute withdrawal of positive expert witness
case for victim's compensation fund + investigation and accountability
did solicitor not get a court order for missing records?
The birth began naturally,
10 days overdue. However, Julia had to be induced twice during the
labour. Throughout the 3 days Julia was denied any pain killers except
for "gas & air" - pethidine and an epidural were refused. Although
she has since seen documentary evidence stating that her baby was
getting very distressed, she was never told. She was wired up to numerous
machines which made movement impossible. A junior doctor was in charge
throughout the labour and it was eventually discovered that the baby was
being presented with face uppermost. This is a very difficult
birth presentation and indeed the baby 's face can suffer damage.
The doctor tried to turn the baby mid-way through the labour which was
excruciatingly painful, and Julia could not help screaming in agony and
inadvertently kicked the doctor. The doctor swore at Julia and she was
told off for upsetting the doctor.
Turning a baby in mid- labour
is not advisable and it failed. Julia never saw her consultant once throughout
the 3-day labour.
Julia's baby girl was eventually
born with the aid of forceps and suction. her forehead and face
were badly bruised and swollen, the baby had two black eyes.
Six midwives were in attendance!
At her 6 week post-natal
her consultant obstetrician told Julia that she had received inhuman treatment
and that he should have been contacted and she should have had an emergency
Julia was left with a damaged
rectum and has bowel incontinence with severe intermittent pain, and
a bladder which is temperamental. Although Julia experiences
a great deal of intermittent pain her GP refused to give her any pain killers.
( Was this because to give her pain killers would admit that the damage
had affected her quality of life?). Julia was offered a bowel repair operation,
although the surgeon said that this would only last 4 to 5 years
and after that she would have to wear a "bag".
Julia decided to take legal
action and obtained her medical notes. As usual
there were critical pages of notes missing and personal, disparaging remarks
. She wrote to SIN: "I have just had the 'pleasure' of reading my
medical records - after a while I had to stop as it was very distressing
and seriously damaged my self confidence." It was not long
before two expert witnesses were found to support her case - a Bowel specialist
and an Obstetrician. The bowel specialist wrote that her condition would
get worse and there was a bleak prognosis. The expert obstetrician stated
that Julia had received incredibly inhumane treatment and that the
consultant should have been called and an emergency caesarean operation
carried out. He claimed that few babies and mothers survive such
a birth presentation.
Julia went on her own to
the barrister's conference very confident that she had enough evidence
to win her case. She as shocked and traumatised when the obstetrician without
warning announced he was retracting his statement on the grounds that if
the birth had been as bad as was thought Julia and her baby would be dead,
and therefore, the birth could not have been as bad as he had stated. Julia,
not her solicitor, challenged him and said he could not retract his statement
as it was a legal document and he had signed it. He retorted he would simply
write another. Julia asked her solicitor to obtain another expert
witness, but was told that there was little point in doing this as it was
notoriously difficult to win a case on damage during child birth
Why was this said £38,000
Julia wrote to SIN: " As
you have probably gathered, your prediction came true as my case was dismissed
at my study conference which unfortunately I had to attend alone. It was
a rather humiliating and traumatic experience, the doctors who were to
prove my case even made jokes about women in childbirth and how things
"went wrong" because they gave birth in the middle of the night rather
than at a "civlised hour"."
The parting "joke" remark
of the expert witness , the Consultant Obstetrician, was that he
hoped he was not called out to deliver any babies at 3 am in the morning,
because he would certainly not be there ..ha, ha, ha". Not a joke which
Julia appreciated! Julia was pleased that she managed to control
herself during the conference, but she broke down later in the ladies loo,
where she found a quiet space to herself. Would these guys like to have
bowel incontincence, and damage so bad that remedial surgery
is required and even then the prognosis is so bleak that a colonectomy
was very likely within a few years, together with a bladder problem? In
addition Julia has been told that she has so much damage to her vagina
that she must never have another vaginal birth.
Not surprisingly, Julia no
longer has any trust in doctors and has decided not to have the repair
bowel operation. She is now putting her faith in homeopathic medicine.
Whether it was related to the traumatic birth which her little girl
suffered, but her baby screamed for no reason for two years and seemed
very unhappy. Julia is very grateful that, against the odds, her
little daughter and she survived.
"cast iron" case which failed.
obstetricians, one verbally and one in writing, have confirmed that she
suffered inhuman treatment, that the birth was dangerous and that a consultant
should have been called and she should have had an emergency caesarean.
to her bowel is obvious (bowel incontinence + severe pain) -
she is in need of a repair operation and a written statement says
her prognosis is bleak.
in severe intermittent pain with a temperamental bladder
is so badly damaged that further vaginal births are not recommended.
never once made an appearance during the three day labour,
not even at the dangerously prolonged second stage
the junior doctor never called the consultant - although the situation
was clearly beyond her competence. The birth began on a Friday and continued
over the weekend. ( It is obviously not advisable to become ill at night,
at the weekends or on high days and holidays - when specialist cover is
an expert witness who retracts a very positive statement at such a late
hour should have to pay some monetary sanction? Julia lost a large
some of money trying to take legal action. Although she was too ill to
work, Julia had to contribute towards her Legal Aid bill because her husband
was working. The total legal bill was £38,000, of which
Julia had to contribute £4000, which she could ill afford. SIN has
always maintained that the only sure winners out of medical
litigation are the lawyers.( NB The Trust's solicitors would no doubt also
have been involved and received some payment)
questions remain: WHY DID JULIA RECEIVE SUCH SUB-STANDARD
CARE, WHICH PUT HER LIFE AND HER BABY'S AT RISK? IN SPITE OF SUFFERING
PERMANENT AND SERIOUS DAMAGE, WHY HAS SHE HAS BEEN UNABLE TO OBTAIN EITHER
COMPENSATION OR ACCOUNTABILITY?
SUCH A CASE WOULD HAVE BEEN IDEAL FOR MEDIATION AND A VICTIM'S COMPENSATION
FUND + AN INQUIRY INTO WHAT WENT WRONG + ESTABLISHING ACCOUNTABILITY
AND SENSIBLE SANCTIONS IF NECESSARY + WHY GIVE THE MONEY TO THE LAWYERS?
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