Memorandum by Brenda Livsey (B10)
I would like in the first instance, to endorse
the written evidence regarding the above subject, submitted by
my fellow Campaigner Rosalind Urion, dated 14th February 2001.
I would, however, like to offer other concerns,
the first expressed by Rosalind Urion in her memo under the title,
The MDA/Biosil/Checks on Manufacturing Standards.
With regard to the allegations against the Scottish
firm Biosil, we have written to Health Ministers and the MDA through
our MP's and MEP's. In the light of the specific criticism made
by the United States Federal Drug Administration regarding Biosil,
as quoted in the Scottish newspaper article of The Daily Record,
28th August 2000, we feel that campaigners and members of the
general public should be entitled to a clear and point for point
answer to our queries.
Points of criticism include a list of manufacturing
procedures not adhered to ie, failure to correct and prevent sub-standard
implants being manufactured—failure to use approved methods
in an element of the process—failure to use correct temperature
of water in manufacturing—failure to maintain the correct
levels of temperature humidity in the factory essential to the
quality of the product, which therefore resulted in detrimental
effects to the implants etc.
It is necessary to look at these factors in
the context of some of the website details of the IRG Report (see
attachment 1).[49]
Here we see that the information from manufacturers on the chemical
constituents used in silicone gel implants was sometimes patchy
and identification of the nature and source of materials tested
was not always possible from the data provided. The Table shows
that toxic chemicals such a Platinum are involved. The Detoxification
process, it is said, depends on the |Curing", that being
the heating of the implants in an Autoclave to the required temperature
levels which also turns the liquid silicone into silicone gel.
Now, although the Biosil firm in question was employed at its
Cumbernauld firm to produce SALINE implants, it must be remembered
that Biosil which is a NAGOR industry, also produces silicone
gel implants at another factory in the Midlands, therefore, if
standards and quality control are failing in one branch, the implications
are that standards are not being met elsewhere in the Nagor empire.
We were all made aware that the Department of Health do not carry
out their own inspections at such factories, but engage independent
"experts" to do the job. We are very concerned about
this, especially when the Department of Health and the MDA were
not aware of the US FDA concerns initially. When we ask about
it, the MDA simply respond with replies telling us that there
is no danger to public health. This blandly patronising response
is unacceptable.
Reportage of Adverse Incidents/Information
My comment on the system of the reportage of
Adverse Incidents are as follows:
I was one of seven women who complained to the
Parliamentary Ombudsman about the MDA regarding the misleading
information and their failure to take account of my report of
implant failure. The Ombudsman, in part, upheld each complaint
which went through the whole complaints procedure. As a Support
Group Co-ordinator at that time, I was able to read some of the
other women's reports and was interested to find that the MDA
had claimed that they had lost the early letters from all of us,
namely, those in which we told of our concerns of ill-health and
implant failure. Fortunately, several ladies have retained copies
of those letters. It was a surprise to me to learn in the Ombudsman's
Report, that when questioned, the MDA said that they would not
include the reports of ruptured implants from patients who had
undergone a process known as "Closed Capsulotomy" as
an Adverse Incident. Not at any time was this information imparted
to me by the MDA, in fact it was never mentioned during any telephone
conversations, that there was even an Adverse Incident Department.
We dealt solely with Dr. Susanne Ludgate & Co. We were not
given any helpful directions whatsoever, in fact, it was by searching
through lots of Department of Health literature that I found out
about the National Implant Register at the OddStock Hospital in
Wiltshire. Trying to get information from the MDA was like trying
to get blood out of a stone, and they were and probably still
are very economical with the truth. A proper reportage system
is crucial to the effectiveness of information.
The MDA now claim that Adverse Reports on Breast
Implants have decreased. This does not tally with the situation
experienced by those trying to run Helplines. I believe that the
problem here lies with the fact that (a) many plastic surgeons
do not regard implant rupture as an adverse incident, (b) the
MDA does not encourage reportage from the patients themselves,
(c) the lack of awareness of the existence of the MDA, as well
as the controversial nature of this problem, will have prevented
a number of plastic surgeons from reporting back to official bodies,
such as the Registry or the MDA (in my own case, my surgeon reported
to neither), (d) the publication of the IRG Report seems to have
led to a proof-of-safety interpretation amongst medical bodies.
This may have increased a general lack of vigilance in terms of
reporting adverse incidents of individual patient's medical devices.
This also leads me to the latest revelation from the MDA that
in their eyes silicone implants are "safe".
I will quote sentences from a letter written
to me by Jeremy Tinkler of the MDA, dated 22nd February 2001.
"The three reviews carried out in the UK and others carried
out abroad, have consistently concluded that there is no credible
evidence to suggest that silicone gel breast implants pose an
undue risk to health. In other words, the concensus conclusion
of expert analysis is that these implants are "Safe".
This conclusion by the MDA has existed since
its inception in 1991; regardless of bans and moratoriums by at
least five major countries and I wonder WHY?
49 Attachment not printed. Back
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