APPENDICES TO THE MINUTES OF EVIDENCE
APPENDIX 1
Memorandum by Dr Sarah Myhill (B 2)
I am a general practitioner with a particular
interest in chronic fatigue syndrome. Over the past twenty years
I estimate I have seen over 1,500 cases of chronic fatigue syndrome
largely caused by viral infection but an important subgroup of
over 100 patients are those whose chronic fatigue syndrome follows
silicone breast implants. During the early years I reported these
cases individually to the Medical Devices Agency, but when it
became clear to me that they took no action whatsoever to investigate
these cases further, I gave up reporting. More recently I have
simply told them the numbers of patients affected and the symptoms
from which they suffer. The Medical Devices Agency has not asked
for any further information nor investigated any of these either
as a group or singly.
The problems from which these patients suffer in
order of importance are:
— Chronic fatigue syndrome characterised
by severe physical fatigue, wide-spread muscle pain and symptoms
of early dementia caused by systemic leakage of silicone.
— Implant hardening—this is often
treated by surgeons who crush the breast with its implant between
their hands thereby rupturing the implant and accelerating other
problems
— Autoimmune disorders causing severe
arthritis
— Nerve damage such as peripheral neuropathy
and multiple sclerosis
— Spontaneous implant rupture resulting
in local migration of the contents. 50 per cent of implants are
ruptured at twelve years, 95 per cent at 20 years.
The Medical Devices Agency has not investigated
a single one of these cases either individually or as a group
despite information being made freely available to them.
Furthermore, these concerns are not being sent
to plastic surgeons and recommendations made by the Independent
Review Group have not been instigated. In particular:
1. Patients are not being given information
by their plastic surgeons about these concerns following breast
implantation. There is no informed consent. Patients are still
being told their implants will last for life with no complications.
2. There is no compulsory register for breast
implant recipients, therefore, long-term problems go unreported.
Voluntary registers are a waste of time because nobody does them,
particularly the plastic surgeons who do not want to find out
that they are directly responsible for so much ill health.
The result of this inaction by the MDA is that
those very concerns which have been identified by the IRG and
are widely reported in the medical literature stand no chance
whatsoever of being investigated further.
For example it should be generally recommended
that implants should be replaced every eight years before they
rupture. Why has this not been done?
If these cases are not being investigated then
Government is not being put in a position whereby it can provide
good information to those patients and surgeons considering a
breast implant.
I have written many letters to the MDA and others
with no response. I think it is time for direct action. So please
give the MDA a kick on the shins from me.
February 2000
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