APPENDIX 4
Memorandum by Christine Williamson (B
6)
I write this submission as one who has severely
suffered as a casualty of the confusions which surround the breast
implant issue. My evidence is based on the experience I have gained
during my voluntary task over the past four years of running a
help line for the many, many casualties who are confronted with
the greatest of difficulties when things go wrong. This task has
become increasingly demanding, to the extent that I have neglected
my own legal pursuit and aspects of my personal life. I am unable,
therefore, to write a lengthy account here; but I will make the
following comments:
Ideally, I would hope to see a moratorium on
silicone gel devices in line with the situation in the USA. If
this cannot be achieved, and in the case of all breast implants,
I would like there to be a compulsory (rather than voluntary)
register from which research could be realistically drawn. I gather
that this, for reasons of confidentiality, cannot be done at present.
But surely some kind of system using numbers, rather than names
and thus protecting the patient's confidentiality could be devised?
Such a system would enable government to obtain precise figures
on implantations, explantations, ruptures and other complications
regarding these dangerous and unreliable medical devices, which
have such a relatively short life span. Anything less than a compulsory
register is useless. As things stand, it is all the more necessary
for there to be something firmer than mere guidelines to require
that people wishing to undertake breast implantation be presented
with a full body of information including the risks and the numbers
of patients reporting disease symptoms and other complications.
In terms of communication/information, a reform in the attitude
of doctors who encounter patients with problems would be helpful,
as well as an improved willingness for doctors to report and confer
on these problems.
Last year, I was included in the NHS working
party which devised a Breast Implant Patient Information booklet
in line with recommendations by the IRG. Those of us in the group
who, as casualties and campaigners, were very concerned about
the risks involved were, naturally, in the minority, but we fought
our corner to get something of the risks included in the booklet.
However, some of the people who read draft copies did not seem
to have really absorbed the comments on risks involved. It seems
to me, then, that this aspect should have been far more greatly
stressed in the booklet. Some of the people who ring me are those
contemplating breast implantation. People who desperately want
to have this operation are only too ready to ignore any but the
boldest of warnings about risks. It is worth mentioning that although
the booklet was published at the beginning of October 2000, nobody
I have spoken with on the help line has so far been presented
with it by a surgeon or by anybody.
I recently accessed the minutes of the Independent
Review Group Meeting. I was surprised to read (item 8 see attached
extract) [1]that
the MDA were claiming a lower number of reports of adverse incidents
than previously submitted to them. This makes me think that there
must be some great gap between the number of reported adverse
incidents and the number of actual adverse incidents. Over the
past year, I have spoken with some 2,000 callers on my help line.
A portion of these are women who are contemplating implants for
the first time and want to hear the pros and cons. But by far
the greatest number are those who are having problems, some of
them severe, including leaked silicone into glands under the arms,
inflammation and serious debility. This involves the need for
removal of ruptured implants. A number of women, even though they
are in pain and unwell will want to have their ruptured implants
exchanged for new implants. I have sometimes advised people to
report to the MDA and the registry if they know they have a ruptured
implant. I am not sure whether or not this suggestion is taken
up. In any case, so many of us have had frustrating experiences
with the MDA, that it is difficult to recommend it with any conviction.
It must be the case that plastic surgeons are not reporting adverse
incidents to the MDA. I believe, too, that the MDA has not sufficiently
gone out to invite reports. Our impression has been that the MDA
does not want there to be a problem and this affects their inadequate
PR. One official will contradict another sometimes when we make
queries.
I believe most strongly that the information
offered by patients themselves on the problems with breast implants
has not been sufficiently taken on board by either the IRG or
the MDA. Casualties are a source of information which needs to
be genuinely heard and circulated amongst medical professionals.
One of the examples of the way in which this clearly was not happening
was at a meeting of plastic surgeons into which I and some other
casualties managed to gain access in November 1998 at the Institute
of Medicine. The form of "information" at this meeting
at which a lecture was given by a lawyer paid by the manufacturers,
was little more than a sales promotion exercise, this at the expense
of patients who were represented as silly or hysterical. So long
as methods such as this are acceptable as a form of the circulation
of information amongst medical practitioners, it seems that there
is a long, long way to go before any balance of information can
be redressed.
1 Not printed. Back
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