Fw: UK Health Committee, AASG, UK (Ros) Memorandum

[Guest guest]

From: " by way of ilena rose " <jward5@...>

Sent: Tuesday, August 21, 2001 9:36 AM

Subject: UK Health Committee, AASG, UK (Ros) Memorandum

> PLEASE POST

>

> Dear Ilena -

>

> Thanks for sending out Health Committee Report UK. & I had worked

> for this for over two years. The Chair, Hinchliffe, MP was very

> sympathetic, but Select Committees in UK,although important are notable to

> exert as much compulsion on Government Departments as we would wish.

> & I gave written & oral evidence. Other capaigers also sent in written

> evidence.

>

> Here is my memorandum of written evidence, submitted to & published by the

> Health committee:-

>

> 'THE PROVISION OF INFORMATION BY THE GOVERNMENT RELATING TO THE SAFETY OF

> BREAST IMPLANTS' MEMORANDUM SUBMITTEDBY ROSE IRWIN OF 'ACTION GAINST

> SLICONE GEL,UK.

>

> 1. I submit my evidence as a casualty of silicone gel` implants and as

> ampaigningpartener with Livsey of AASG,UK. Ms Livsey and I have

been

> in communication with, & read reports of alarge number of silicone implant

> casualties. Our concerns lie primarily with silicone implants involving

> silicone gel.

>

> These are the implants which by far outnumber any other breast implant

used

> in the UK. It is from this type of implant that we receive the largest

> number of reports of adverese effects. We confer with fellow campaigners

on

> the whole breast implant subject. We also tryto consult with`medical

> bodies.We havebecome conversant with the conflicting clinical studies &

> with the man aspects - including the problematicalarea of patient

> information - which continue to surround this compex issue.

>

> 2. EXECUTIVE SUMMARY.

>

> As a casualty, & campaigner for a moratorium on silicone gel implants it

> will be impossible for me to avoid any mention whatsoever of disease

> aspects. I will strive to keep this aspect within the terms of reference

of

> this inquiry. It will also be necessary for me o alludeto my personal

> experience, but onlyin the light of its relevance to the general points

> which this, along with reports from fellow casualties, endorses.

>

> The overwhelming factor which has emergedfor us has been the need for

> radical moves away from the didatic to the consultative apprach in

relation

> to medical bodies & many health professionals. This is integral to the

best

> means of information base on a combination of professional expertise &

> patient feedback.

>

> A large part of this most welcome inquirysurrounds the issue of the

> dissemination of information - particularly with reference to the risks

> involved. It is essential to say here that the dissemination of

information

> is crucially bound up with the ways in whih that information is

> GATHERED,ASSESSED and COMPILED.Much of our frustration in trying to

> represent silicone casualties lies in the great shortcomings of these

> components, as well as in the problems ofdissemination of the actual

> information.

>

> 3. OUR AIMS FOR THE OUTCOME OF THIS INQUIRY ARE AS FOLLOWS:-

>

> -Some form of moratorium on silicone gel implants, at least until the

risks

> over benefits equation is more clearly established, along with a firmer

> policy on patient awareness of risk factors.

>

> - Failing the above, a binding obligationfor patients contemplating

> silicone breast implantation ( & possibly other types of breast implants),

> to read & sign to say they have read & understoodthe full list of risks

> drawn upfrom peer-reviewed evience on both sides of the argument, as well

> as from anecdotal evidence. This would tlly with the situation in New

> Zealand.

>

> - A method of take-up from patients;' reports of ill-advised procedures by

> surgeons, (e.g. closed capsulotomy) in terms of inspection and checks on

> such surgeons. At present there\appears to br no body which is equipped

for

> this purpose. It is outside the remit of the MDA. The GMC has proved far

> too generalised & bureaucratic to fulfill such a role.

>

> - A more honest admission in PR information on the inconclusive results of

> clinical research to date. At present,for example, a careful reading ofthe

> IRG reports's website detail shows man areas of 'don't know', 'further

> research needeed' in terms of disease links. This is not sufficiently

> reflectedin the message of the IRG Summary Report which comes across

rather

> as 'silicone-implants-safe'. This, in turn, has been re-interpreted by

many

> plastic surgeons as 'proof-positive-of safety-by the-IRG'

>

> -DIrectives which will encourage medical professionals to take a

> consultative rather than defensive approach with silicone impkant

> casualties. This aim is linked to the need for appropriate therapy &

> continuing research take-up from existing peer reviewed clinical studies

> indicating disease links.

>

> - An improved reportage system from the MDA on adverse incidents,

including

> botyhmedical professionals AND patients. A proper take-up & investigation

> of all reports of adverse incidents as stated inthe principles of the MDA

> Framework Document

>

> - An improved method of arbitration in terms of consultative skills from

> the parliamentary Ombudsman.

>

> I submit my evidence in order of the ' Terms of Reference@ of the Health

> Committee Press Notice:-

>

> THE ROLE OF THE MEDICAL DEVICES AGENCY.

>

> The Medical Devices agency (MDA) was formed as a whole agency absorbing

the

> pre-existing Adverse Incidence Centre in 1993. The MDA reviewed the

> evidence on disease links with silicone gel implants & recommended that

> they should remain in use in the UK, all this in advance of itsofficial

> opening as the MDA. When flesh & blood casualties attempted to report

> problems, therefore, after its official opening, the MDA had acquired a

> closed-door attitude. Officials were scrupulous in replying to

> correspondence which, in my own case was prolific (for I was, in

> part,attempting to convince them of the progression of my disease with

> implant rupture and leakage); but the replies were politely didactic

> rather than in any way consultative. There were inconsistencies from

> different officials in replies to queries . Sometimes I was given

> deliberate misinformation as, for example, when I enquired about the

> policies in other countries on the use ofsilicone gel implants.

>

> Most seriously of all, the MDA failed to confirm and investigate my

> persistent efforts ver twoyears to report bi-lateral rupture & leakage of

> my implants. This technical dailure constitutes an adverse incident. The

> MDA Framework Document states that reported adverse incidents will be

> 'takenup and properly investigated' When I reported implant failure,Iwas

> simply thanked & told how useful my information would be, this without any

> initiatives bytheMDA to confirm my report. I put together my criticisms of

> the MDA and sent them by letter to the then Chief Medical Officer

> (CMO) Calman. I asked in my letter about the accountability of the

> MDA. In reply, I recieved a solicitr's letter from the CMO's office

> forbidding further correspondence. I recieved no replies to my points of

> criticism. Late, communications with the MDA were resumed,but the attitude

> had not improved.

>

> Subsequently, I found six other women whohad also tried (in writing) to

> report implant failure to the MDA without success. We wrote around to some

> twenty plastic surgeons (Elaine Coomber, SOS co-ordinated this exercise)

to

> discover a) whether or not they were aware of the MDA and whether they

> regarded implant rupture as an adverse incident and would report it as

> such. The reploes wee varied. A letter from the then Chairman of AAPS told

> us that plastic surgeons would NOT regard implant rupture as an adverse

> incident and would not report it as such. Meantime, the MDA in a 1996

> publication gave a figure of 7 reported adverse incidents for silicone gel

> implants. This did not include our attempted reports, nor those we knew of

> rom others who had tried to report problems by phone to the MDA. Others we

> spoke to on the help line said they would not bother, having heard of our

> futile attempts, with the MDA....

>

> TO BE CONTINUED - Lack of time prevents me from completing this copy of

my

> memorandum to post at present, Ilena! Other aspects which were inclded in

> my account were under the following headings: THE MDA/PARLIAMENTARY

> OMBUDSMAN. -THE MDA/NATIONAL BREAST IMPLANT REGISTER/ OMBUDSMAN (

COMPLAINT

> TO) - MDA/BIOSIL/CHECKS ON MNUFCTURING STANDARDS. -MDA/IRG (Criticism of

> the lack of independence with evidence) INFORMATION PROCESS WHEREBY

> RISKSARE DISSEMINATED (ie. lack of it)and THE INFORMATION PROVIDED BY

DEPT

> OF HEALTH DIRECTLY TO THE PBLIC & ACTION TAKEN IN RESPONSE TO CONCERNS

> RAISED (This suppied

> evidence of misinformation from this DEpartment.

>

> The memorandum was submitted in advance of the inquiry itself. Some of the

> points raised in the oral evidence came out of this material.

>

> Full accounts of all oral & written evidence can be obtained from UK from:

> The Stationery Office LTd PO Box 276, London SW8 5DT, UK.

>

> In the light of recent news about possibility of the FDA's eventual

> approval of silicone gel implants,the usefulness of present steps forward

> becomes less certain, alas!

>

> Cheers!

>

> Ros, AASG,UK

>

>

>