Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by Professor David T. Sharpe O.B.E. (B 11)

  I am writing on behalf of the British Association of Aesthetic Plastic Surgeons regarding the Health Committee enquiry into the provision of information by the Government into the safety of breast implants. I also represent EQUAM (European Committee on Quality Assurance of Medical Devices in Plastic Surgery), am Chairman of The Breast Special Interest Group of The British Association of Plastic Surgeons and the Past President of The British Association of Aesthetic Plastic Surgeons.

  While I recognise that the issue of the safety of breast implants is not under discussion I feel it is necessary to summarise current orthodox medical opinion on silicone gel breast implants. As I realise that the Committee will have been petitioned by Anti Silicone Group Campaigners I wish to deal with their concerns over local complications of breast implants.

  It is quite true that in 1991 the FDA imposed a moratorium on silicone gel implants for cosmetic purposes but continued to allow them for breast reconstruction. This was because there was insufficient information to refute the allegations that they were a health hazard. Time has moved on and an enormous number of independent reports have been produced by scientists and physicians, including the Report of the Silicone Gel Breasts Implants Independent Review Group (Department of Health, United Kingdom), who can find no link with systemic disease.

  Statements from the American College of Rheumatologists, American Medical Association and the American Academy of Neurologists and even the FDA themselves confirm the absence of evidence in favour of health hazards. Recent epidemiological studies including the women's cohort health study of 425,000 medical workers and numerous other studies throughout America and Europe have shown that despite some theoretical evidence of a mechanism which could cause illness none has been demonstrated, in other words women with breast implants within a single cohort have no significant difference in illness to those without them. The complex scientific evidence associated with the controversy has been reviewed by a number of independent review groups. Judge Pointer set up a scientific panel of independent experts and most recently the Institute of Medicine in America consisting of 13 physicians all established an absence of systemic illness. This is indeed fortunate as silicone is widespread throughout society being used in products which can be inhaled and in direct contact with the body, such as lubrication for all needles and syringes (a diabetic would accumulate more silicone in a life time at injection sites than would leak from breast implants), an anti-foaming agent in food stuff, for example Infacol which is anti-flatulence remedy given to infants orally, is 100 per cent silicone and cosmetics, floor polish, aerosols etc all contain it.

  The FDA has not yet lifted its moratorium although experts in the States feel that is about to do so. It is, of course, being targeted by lawyers who wish to maintain the confusion and controversy as the lifting of an embargo would deprive them of large sums of litigation revenue.

  Controversy now centres on the integrity of implants themselves and the complications that might occur locally following their rupture. There is no question that breast implants even though very effective do have a down side which must be properly evaluated by the clinician and patient before their use but I am passionate in my belief that inaccurate poorly controlled studies and junk science should not prevent the use of these valuable devices by creating an aura of unscientific mistrust and prejudice.

  Briefly there are three generations of implants.

  The first manufactured from 1963 to 1975 had a thick wall and contained silicone gel, few of these ruptured and many are still in place today without problems.

  The second-generation implant from 1975-86 was fundamentally flawed, had a thin wall and 50 per cent of these ruptured within 15 years. I have personally dealt with a large number of them and recently published a paper in the American Journal of Plastic and Reconstructive Surgery of 482 the largest personal series in the World. The consequences of rupture were in every case insignificant and easily dealt with although one or two of these cases required some resection of breast tissue.

  The third generation implants from 1986 onwards have much thicker shells and have very much lower rupture rates. I have used 1,500 in the last ten years of which I have operated on 150 of these for reasons of capsular contracture, concern regarding the silicone controversy and for change of size. In only two of these were there any rupture, none of which entered the breast tissue.

  Many of the anti-silicone breast implant campaigners rely on the study by Lori Brown previously of the FDA. This study is fundamentally flawed because it discusses only second generation implants and completely ignores the first generation and excludes third generation implants for non-scientific reasons. The Editor of the Lancet agreed with my condemnation of the paper and refused to publish it, and it may be very interesting to you to see a review in the Washington Times which speaks for itself of which I enclose. [6]It was of great interest to the Editor of the Lancet that publication was expected as he would like to think he presides over a journal which is subject to scientific scrutiny and is not a forum for political intrigue.

  The limitations and potential hazards of implants have been well set out in the Department of Health leaflet, Breast Implants, information for Women considering breast implants, which will be familiar to you and I believe this to be an authoritative analysis of the pros and cons of the use of breast implants which was compiled with the main breast implant protest groups, and I myself was on the panel. Armed with this leaflet and with the advice of a properly qualified plastic surgeon, I believe women are able to make an informed decision on the suitability of implants.

6   Not printed. Back

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