Select Committee on Health Minutes of Evidence

Memorandum by Paul Balen Freethcartwright Solicitors (B 15)


  1.  Breast implant suppliers in the UK have not been asked to produce long-term safety data to the Medical Devices Agency prior to licensing.

  2.  In the case of silicone implants women are being asked to demonstrate lack of safety instead of manufacturers demonstrating long term safety.

  3.  In spite of three Government sponsored reviews of silicone implants research has only involved a meta-analysis of existing literature. No steps have been taken to sponsor research on UK women patients.

  4.  Only saline implants are licensed for use in USA and only since May 2000.

  5.  Trilucent and Hydrogel implants have both been banned by MDA after receiving CE marking from European Notified Bodies and being supplied for years in the UK.

  6.  Failure of the licensing system to require production by manufacturers of adequate safety data prior to licensing and supply has led to the female population being treated virtually as guinea pigs for the testing of breast implants.

  7.  The Consumer Protection Act fails to protect consumers and as currently applied serves to protect suppliers.

  8.  There is a lack of informed consent by women seeking breast augmentation.

  9.  There is a lack of Governmental control over the cosmetic surgery industry generally and cosmetic surgeons in particular.

  10.  Breast augmentation operations have a high incidence of complications. 80 per cent of implants rupture within 15 years of insertion. Product failures create human tragedies and increased costs to the state.

  11.  There is a need for tighter regulation, licensing, and monitoring of implants and their manufacturers and suppliers by MDA and a review of the CE licensing system and the public accountability of Notified Bodies.

  12.  There are substantial deficiencies in the steps taken by the MDA following hazard and warning notices relating to Trilucent and Hydrogel implants. The Government may have misled Trilucent victims and failed to anticipate and deal with problems arising from the recommendation that woman have their breast implants removed.

  13.  The MDA and/or Department of Health has failed to obtain the co-operation of the suppliers of Hydrogel implants when suspending the supply of these products in the UK to ensure women may obtain free medical attention.

  14.  Failures by the MDA or Department of Health have unnecessarily increased the distress of women who received Trilucent and/or Hydrogel implants.


  1.  We recommend that the standard consent form used should contain an interactive element in which the patient is encouraged to display her understanding of the issues/risks involved. We recommend that such interactive consent form should be prescribed by the D of H and/or all relevant professional bodies.

  2.  We recommend that the MDA clearly explain to women why the use of silicone implants has not been suspended for cosmetic purposes when the suppliers of such implants in this country have not been asked to satisfy the MDA that they have acceptable long-term safety data.

  3.  We recommend that only plastic surgeons duly accredited by the relevant Royal College should by law be able to describe themselves as cosmetic surgeons.

  4.  We recommend that there should be a legal duty on clinics to inform patients in writing of the identity and professional standing of the surgeons operating at their premises and a professional duty on such surgeons to do likewise.

  5.  We recommend that the Government insists that Notified Bodies provide public access to conformity assessment documentation.

  6.  We recommend that trial data be sought before licensing and supply to avoid withdrawal of implants after they have already been inserted in large numbers of women.

  7.  We recommend that the MDA should carry out regular rigorous inspections of implant suppliers based in their country and publish its inspection reports.

  8.  We recommend:

    —  Use of the Breast implant registry should be compulsory.

    —  Notification of failed implants should be compulsory.

    —  Notification of possible side effects/complications should be compulsory.

    —  The breast implant register keeper should publish annual league tables showing numbers of implants used; failure rates and complications reported.

  9.  We recommend that the onus of proof should be reversed in product liability cases and that the Government be invited to propose an amendment to the Consumer Protection Act 1987.

  10.  We recommend for the future that when a product is withdrawn, the D of H and/or the Medical Devices Agency ensures that a system is set up which guarantees treatment free to the patients and provides for resolution of disputes without patient involvement.

  11.  We recommend that in future cases, and in the Trilucent case, the Department of Health insists on the formation of a panel of wise men representing manufacturers and plastic surgeons who could decide in any individual case the responsibility for covering the costs of future treatment.

  12.  We recommend that the MDA/D of H produce evidence that the companies supplying Trilucent implants had agreed to pay all medical expenses. If it transpires that the assurance to women that "you will not have to pay for this" was an assertion without foundation, we recommend that the D of H provide funds to affected women to meet the shortfall in medical expenses and associated legal costs.

  13.  We recommend that in cases in which an immediate decision as to the liability of costs for future treatment cannot be reached, the MDA/D of H should insist that AEI or the equivalent company should bear initial responsibility so that the patient is absolutely protected and has the treatment she is recommended to have and requires, whilst the eventual liability is resolved between AEI and the companies or surgeons involved. The principle to be adopted in these cases should be that the patient's health and well being comes first and that the patient should not be concerned with payment for operations necessitated as a result of shortcomings in the manufacturing and licensing processes.

  14.  We recommend that our proposed system of compulsory registration should apply to both private and NHS sectors and that there should be an obligation to record the identity of the implants used both in the register and in the patient's medical records.



  1.1  Freethcartwright is a 45 partner firm of solicitors based in the East Midlands. It has a national reputation for its medico-legal practice, which includes a specialist product liability unit. The firm currently acts for over 4,000 women who have had breast implants and liaises with over 250 other firms of solicitors acting for many more women.

  1.2  Paul Balen who is the author of this paper heads the firm's specialist medico-legal and product liability units. Paul is one of only three solicitors in the country to be awarded a Senior Fellowship of the College of Personal Injury Law; is a past Secretary of the Association of Personal Injury lawyers and co-author of Multi-party Actions published by the Legal Action group in 1995. He is an assessor for the Law Society's Specialist Clinical Negligence Panel and a member of the Personal Injury Specialist Panel.

  1.3  Freethcartwright have acted for breast implant women for around eight years. Paul negotiated the protocol for settlement of the claims by recipients of the 3M Capital Hip Prosthesis which was the subject of a Medical Devices Agency (MDA) Hazard Notice in 1997; negotiated the settlement protocol for the women who received the Trilucent soya breast implants and acted for two of the six lead case Hepatitis C claimants in the contaminated blood claims against the National Blood Authority, the trial of which took place at the end of last year and in which judgement is awaited.


(a)  America

  2.1  In the early 20 century doctors seeking to enhance women's breasts attempted to use fat taken from the patient's own bodies. Although these operations initially appeared successful after a while it became apparent that the fat was being absorbed back into the body leaving the breasts back in their previous state.

  2.2  The search was on for an alternative solution. At one stage in the 1930's surgeons even used glass balls to increase breast size.

  2.3  In that same decade scientists developed silicone, a long thin flexible polymer made up of repeating molecules of oxygen and silicone. They found that silicone could be linked in relatively short chains to make a rather runny liquid or into longer chains, which were more rigid. There was no immediate use found for silicone and it remained a laboratory curiosity for the next 10 years. Then in 1943 two large American corporations Dow Chemical Company and Corning Glass works joined forces in a joint venture to develop uses for silicone as a substitute for rubber. Dow Chemical developed silicone gel, which the new company Dow Corning marketed for use as an insulator, a coolant, for lubrication and for sealing transformers. Silicone was also subsequently marketed to children as silly putty (play dough).

  2.4  In the 1950's surgeons saw a use for silicone as a means of breast enhancement. Originally it was injected directly into the body with disastrous results. Serious medical complications and deaths ensued and the technique was banned.

  2.5  The solution surgeons came to was to create a silicone envelope using the longer polymers which contained the silicone gel. This had the advantage of retaining a more natural look without the silicone running free inside the body, which had led to the disasters with the direct injection technique.

  2.6  The silicone material was supplied to the breast implant industry by companies such as General Electric. They made it clear that the silicone it supplied had never been tested or approved for human use.[1]

  2.7  The early implants had a thick outer shell which women complained gave them an unnatural rigid look. In the mid-1970's the manufacturers responded by producing thinner shells.

  2.8  Although manufacturers had begun widespread marketing of silicone implants in the early 1960's, it was only when complaints reached a crescendo in America in early 1991 that the Food and Drugs Administration (FDA), which had not previously regulated breast implants, called for manufacturers to supply information demonstrating their safety. Because there had been no human safety trials, they were not able to do so by the deadline of July 1991. Data from the American Society of Plastic Surgeons at this time showed that of two million women with breast implants, 123,000 had breasts, which had hardened, and another 155,000 had suffered rupture or infection.

  2.9  In 1992, after two hearings before independent advisory committees the FDA banned the use of silicone breast implants except in limited research.[2] Most breast implant manufacturers then withdrew from the market in the USA. Japan, Australia and Canada followed the American example and banned the use of silicone breast implants.

  2.10  In America therefore since 1992 silicone gel implants have been banned except where authorised for a study approved by the FDA under an investigational device exemption. A typical approved study would require follow up for at least 10 years post implantation and overview by an institutional review board. The only exceptions to this are where the implants are required for reconstruction purposes after a mastectomy, or to replace a previously failed silicone gel implant. Even these women are followed by a study for a minimum of five years. Women requiring breast implants for cosmetic purposes cannot be enrolled in these studies.

  2.11  Litigation began in America in the early 1980's. Women alleged that the manufacturers had claimed that the implants would last a lifetime unless exposed to external trauma, even though there was increasing evidence that implants ruptured and leaked for no apparent reason. As a result many women were faced with having to have replacements. It was also alleged that implants were responsible for a wide range of auto-immune type disorders. Documents recovered from Dow Corning showed that it had conducted no long-term safety studies even though product literature implied that it had been done.

  2.12  Thousands of women worldwide joined the American cases. In one individual instance an American woman was awarded £17m after she claimed that silicone had leaked from two sets of implants. Manufacturers and their insurers facing these claims felt that their value and the companies' legal costs might exceed their assets and insurance cover available.

  2.13  The solution proposed was a global "no fault" settlement involving women from all over the world and most manufacturers. This settlement was supervised by a Judge in Birmingham Alabama but the proposals foundered when it became clear that there were more women eligible to claim than assets available. The settlement collapsed. One of the biggest players Dow Corning sought shelter in the American Chapter 11 Bankruptcy rule days after declaring record profits on a record turnover. Other smaller companies surrendered their assets to women claimants so each woman received a small payment. The remaining companies such as 3M, Baxter and Bristol Myers put together a replacement settlement while Dow Corning submitted settlement proposals within its bankruptcy.

  2.14  British women received small payments from various US bankruptcy settlements and larger payments from the revised global settlement. The Dow Corning bankruptcy settlement proposals should lead to further payments to UK women subject to the appeals which are currently pending through the US Court system. None of the payments require proof of fault or admission of liability. Most do not require proof of causation. Higher payments are available for women who demonstrate on medical evidence that they are suffering from one or more of a series of listed diseases. Causation evidence is not required. We have so far distributed around £2 million to our clients who have registered under the various American settlement schemes.

  2.15  In May 2000 the FDA for the first time licensed the use of saline implants. Silicone implants remain banned. The health issues related to silicone implants remain highly controversial. For every paper published exonerating silicone another appears condemning it. One proposed explanation has been that silicone caused a unique species of disease process, which cannot be defined by existing criteria. It was in other words an a-typical disease process.

  2.16  As an article by two American doctors in the British Medical Journal in 1994 pointed out:

    "The question of risks to health . . . is difficult to study. No precise data exist on how many women have received silicone implants; no systematic follow up data has been collected. Virtually nothing is known about how many women have had repeat procedures or how many with silicone breast implants have died."[3]

What is not in dispute is that these implants were originally marketed without long-term human safety data being available.

  2.17  As recently as 14 December 2000 one of the American suppliers announced:

    "Mentor, a leading medical device company that makes breast implants, has recently started a clinical trial for silicone gel-filled mammary implants."

(b)  The UK

  2.18  Breast enlargement is the most common cosmetic surgical operation performed on women in the UK.[4] The use of breast implants in the United Kingdom followed the pattern experienced in the USA with most implants originating from American suppliers. Americans also set up companies in this country while the Government became indirectly involved as backers of Remploy, the company for the disabled, which assembled implants for Nagor, a cosmetic appliance company based in the Isle of Man.

  2.19  The first governmental involvement appears to have been a referral by the Department of Health to a committee considering possible carcinogenic effects of silicone implants between 1989 and 1990. The FDA's action in banning silicone implants in the USA prompted a health circular from the Chief Medical Officer in January 1992[5]. No ban was imposed in the UK but the position was to be reviewed, as more information became available.

  2.20  The Department of Health convened a meeting of independent experts whose conclusions, reached it appears in April 1992, were circulated with a further Dear Doctor letter nearly a year later on 25 March 1993.[6] The Review[7]concluded.

    "there is no evidence of an increased risk of connective tissue disease in patients who have undergone silicone breast implants and therefore no scientific basis for changing practice or policy in the UK".

  2.21  As will be commented upon later such a conclusion was simply based on a review of available literature. Not for the last time in the saga of breast implants no review of actual British patients' experiences was conducted whilst the usual burden was reversed—patients being expected to prove that the product was unsafe rather than manufacturers being asked to prove safety and regulators being asked to satisfy themselves that the product was safe.

  2.22  One interesting and concerning effect of the report was the fact that it was then repeatedly used by American manufacturers in their own country as evidence that their implants were safe. The theme being that if the British Government says they are safe they must be, or that at least the British Government supports our position.

  2.23  As a result of a recommendation in the report a voluntary breast implant patient registry was set up to facilitate surveillance of women with breast implants. This was based at the Wessex Centre in Salisbury and came into existence in July 1993. The report also recommended that women should be informed of difficulties in assessing breast disease in women with implants, but emphasised that the responsibility for doing so rested with the surgeons.

  2.24  As the silicone controversy in America deepened at the end of 1993, the Department of Health asked the independent review group to review all literature on the subject that had been published since 1991. The review[8] concluded that there was no proven link between implants and disease. However, closely read, the report clearly indicated that the evidence was inconclusive. It again recommended no change in UK policy. Again the onus was placed on patients to prove defect rather than suppliers to prove safety. Again the report was a meta-analysis of published literature and involved no new patient orientated research. Again the report concentrated solely on the alleged link between implants and autoimmune disorders or connective tissue disease.

  2.25  Some idea of the attitude of the time is conveyed by the response of the Senior Consultant Plastic Surgeon delegated by the Government to run the implant registry:

    "I am afraid the information on the registry is not available to anyone, except the Department of Health and those people who participate in the providing of information in the first place. Even those people are not privy to the entire contents of the registry. I am sure you are well aware that the only pay out that is likely to take place is the covering of fees for the removal of prostheses if people so wish.[9] There is no evidence anywhere in the world to implicate an association between breast implants and any other form of known human disease. There have been papers that claim this but the statistical base from which they have worked is extremely thin and the manner of gaining information and material highly suspect.[10]

    And as he wrote to a patient:

    "I think that it is important that you realise that if you register with the American court, you give up all rights for subsequent claims against any manufacturer or any other person. The whole point of registration is simply for the Americans to count up the size of the litigation problem and I have to tell you they have very firm views about who will and will not get any form of compensation and their considered view at the moment is that practically no-one will get any. The reason for this is that when the proof comes out that there is absolutely no association between silicone and any other form of human disease, then the need to compensate will be removed.[11]

  2.26  Communicating with patients, particularly when the bulk of them have been dealt with through the private sector, is far from easy, and obtaining information from such patients is similarly difficult. Even though most patients with implants qualified for payments from American settlements simply by registering, the reticence and often obstructive attitude of the medical profession was exemplified by the direction given to surgeons by the Medical Protection Society and Medical Defence Union that:

    "it was inappropriate for surgeons to contact patients directly unless they have knowledge of the patient having suffered because of the implantation of breast implants.[12]

  2.27  In the private sector driven by financial considerations there was no incentive to contact patients and it appears neither was there any professional obligation.

  2.28  The Government did step in to help by issuing a press release[13] prompting women to consider registering with the American settlement. There appeared to be no discussion with the legal profession dealing with such claims in this country, which presumably accounted for the incorrect opening sentence[14] and the generally lukewarm message conveyed. The D of H was clearly caught between opposing considerations—encouraging women to claim what was rightfully theirs to claim, but reassuring them and others at the same time.

  2.29  General concern at the problems reported by patients and their representatives led the Government to commission a third review which was announced on 4 June 1997. This time the terms of reference were somewhat wider than before:

    "To review the evidence relating to possible health risks associated with silicone gel implants, examine the issues relating to the adequacy of pre-operative patient information and report to the Chief Medical Officer on its conclusions".[15]

  2.30  The writer was invited to give oral evidence to the committee (the IRG). We revealed that of 1,750 women instructing freethcartwright, 288 had informed us that their implants had ruptured and 294 claimed they had a breast implant related illness. In 1995 we had carried out a survey of other solicitors representing a total of 2,109 breast implant clients, 796 of whom claimed they were suffering from a breast implant related disease and 226 of whom had suffered a rupture.

  2.31  We believed that these figures were significant bearing in mind that women were required to register with American settlements even though they were suffering from no problems at all. We felt that the high incidence of ruptures and claims of disease in our sample ought to be of sifgnificance and ought to be researched. We offered to assist such review by encouraging clients to make their medical histories available to the IRG. Our offer was not taken up.

  2.32  We also recommended that the medical profession should be required to inform women considering implants as a minimum that:

    (a)  There is a scientific debate on the effect of silicone implants on the human body.

    (b)  Silicone implants have never been the subject of human safety trails on a long term basis.

    (c)  There is a high statistical probability that the implants will fail to last for the remainder of the woman's life.

  2.33  The report from the IRG[16] was once again not based on any of its own scientific research. This time its detailed review of published literature and its evaluation of the witnesses it had interviewed led for the first time to a call for more research. It concluded that there was no good evidence for the existence of a silicone related disease noting that problems could be caused by the body's natural response to foreign materials, and accepted that there were issues such as the precise incidence of rupture where scientific data was incomplete. Apart from recommending better counselling of women before they consented to implantation, the UK Government policy on silicone implants remained unchanged.

  2.34  We have seen little evidence that the recommendations relating to patient information and follow up have been adopted as compulsory by the medical profession. The fact that most operations are advertised and carried out in the profit making/private sector that remains largely unregulated currently militates against enforcement of these desirable practices.

  2.35  We, like the IRG, have concerns at the lack of informed consent and external pressure brought to bear on women considering breast implants. The recent publicity given to a 16 year old girl's desire for implants is an illustration of this. Issues of informed consent are not unique in breast augmentation surgery. However, as the commonest cosmetic operation and one with a track record of complications, we recommend that the standard consent form used should contain an interactive element in which the patient is encouraged to display her understanding of the issues/risks involved. We recommend that such interactive consent form should be prescribed by the D of H and/or all relevant professional bodies.

  2.36  It is also alarming to note that years after the breast implant issue first raised its head, the IRG acknowledged that scientific data was incomplete. Yet again there was little evidence of an obligation, assumed to exist in relation to other products, that it must be for the suppliers to demonstrate safety, not for patients/consumers to demonstrate defect/lack of safety. This is particularly striking for a product for which there is no urgent therapeutic benefit

  2.37  One practical and praiseworthy consequence of the report was the publication by the D of H in October 2000 of a booklet "Breast Implants—Information for women considering breast implants."[17] The fact that the D of H took this step illustrates the importance of the issue. At the same time the Government's role in all this remained unclear[18].

  2.38  The booklet clearly spells out that having breast implants is a long-term commitment for a woman. For the Government the commitment is that it:

    "will continue to evaluate carefully any new scientific evidence. Should the conclusions previously reached about breast implants change in the light of this ongoing evaluation, then further advice will be communicated to the public.[19]

  2.39  There is no explanation in the booklet of the Government's licensing role or of the fact that when listing Hydrogel implants as an alternative type of implant it must already have had concerns about their safety. There has still been no approach to review the medical experience of UK women who have received silicone implants. Presumably, the absence of any Government sponsorship, whether research takes place is at the whim of interested surgeons and the availability of sponsorship monies. Plastic surgeons operating mainly in the private sector appear to have little incentive to pursue such research. Oddly in view of the pre-emptive steps taken by the Government in respect of Trilucent soya implants and Hydrogel implants in banning products because of lack of safety data, so far as silicone implants are concerned the current position remains that the onus is placed on women to prove defect and not on suppliers to establish safety.

  2.40  It is noteworthy, however, that this move to provide information came no less than eight years after the FDA in America had decided that such information should be given to American women.[20] As we explain below, many women chose alternative breast implants because of concern about the safety of silicone breast implants. Many of our clients now have had to have those implants replaced with silicone implants following MDA advice. There is widespread concern as to whether the long-term safety of those implants has been demonstrated.

  2.41  We recommend that the MDA clearly explain to women why the use of silicone implants has not been suspended for cosmetic purposes when the suppliers of such implants in this country have not been asked to satisfy the MDA that they have acceptable long-term safety data.

  2.42  We are also concerned at the side of the medical profession operating on women in cosmetic clinics. There appears to be no control over who can describe themselves as Cosmetic Surgeons. In one recent medical negligence claim arising from cosmetic surgery which we conducted, not involving breast implants, we discovered that the surgeon operating was not an accredited plastic surgeon but a moonlighting general practitioner with a criminal record for assault and prescription offences. It is also interesting to observe that following the recommendation that Trilucent implants should be removed, at least one well known cosmetic clinic wrote to patients explaining that because removal of Trilucent implants was complicated, the operation would have to be conducted by a plastic surgeon rather than the original surgeon used at the clinic.[21]

  2.43  We recommend that only plastic surgeons duly accredited by the relevant Royal College should by law be able to describe themselves as Cosmetic Surgeons.

  2.44  We recommend that there should be a legal duty on clinics to inform patients in writing of the identity and professional standing of the surgeons operating at their premises and a professional duty on such surgeons to do likewise.



  3.1  All implants have silicone envelopes—it is their contents which differ. However, the original implants contained silicone gel and these are by far the most common. There are three main types:

    (a)  Single lumen—a silicone shell containing silicone gel.

    (b)  Double lumen—a silicone inner shell filled with silicone gel within an outer silicone envelope.

    (c)  Polyurethane foam coated outer silicone envelope with a gel filled inner silicone shell.

  3.2  Silicone implants are not licensed for use for cosmetic surgery in the USA.


  3.3  The silicone envelope of these implants is filled with a salt-water solution and can be supplied either ready filled or to be filled after insertion through a valve at the time of surgery.

  3.4  Saline implants were finally approved for marketing by the FDA in the USA on 11 May 2000.


  3.5  Soya implants were marketed under the trade name Trilucent. They consist of a silicone envelope filled with soya bean oil. The were manufactured by a Swiss company Lipomatrix Inc and supplied in the UK by Collagen Aesthetics UK Ltd, a subsidiary of an American corporation. These implants were never licensed in the USA where they were invented, but were licensed in the UK via the EC. Over 9,000 implants have been implanted into around 5,000 UK women. Many women specifically opted for or even switched to soya implants because they were marketed as the natural, safer alternative to silicone and were also amenable to scanning.

  3.6  In March 1999 the Medical Devices Agency effectively banned the further use of these implants in the UK because of concerns about potential adverse health effects of the breakdown of the soya filler in the human body. Members of the D of H Committee on Toxicity recommended that further data be obtained. The manufacturer's voluntarily suspended supply and the MDA issued an Advice Notice.[22] The Advice Notice stated that there was no evidence to suggest that the implants should be removed but that women should seek immediate medical advice if they experienced swelling or inflammation.

  3.7  On 6 June 2000 a Hazard Notice[23] was issued by the MDA recommending the removal of Trilucent breast implants because of potential genotoxic components from the breakdown of the soya filling.


  3.8  The envelope of these implants is filled with a gel made up of water, sugar and salt which if they leak or rupture should have the advantage that the body will easily excrete the solution. Hydrogels are polymeric materials that have the ability to swell in water without dissolving and retain water within their structures.

  3.9  Until December 2000, there were two models of Hydrogel filled breast implants on the UK market. PIP Hydrogel breast implants were made in France and supplied in the UK by Clover Leaf Products Ltd. Approximately 4,000 women in the UK received these implants since they were first introduced in 1994. NovaGold breast implants were made in Germany and supplied in the UK by Somatech Medical Ltd. Approximately 250 women in the UK received these implants since they were first introduced in 1996. It is estimated that around 80 per cent of these implants were implanted by the private sector for cosmetic reasons.

  3.10  In December 2000 the MDA issued Device Alerts [24] as a result of which both PIP Hydrogel and NovaGold products were withdrawn from the market. The MDA revealed that although few adverse incidents have been reported as part of its ongoing review of breast implant products it had identified:

    "that the manufacturer's safety assessment was inadequate, due to lack of long term toxicity data or clinical follow-up, together with methodological flaws in some of the pre-clinical tests."


  4.1  When in 2000 the FDA licensed saline implants for the first time it became evident that the true rate of complication was almost certainly underestimated by manufacturers and doctors alike. Using data collected by one manufacturer Mentor Corpn, 43 per cent of women who had augmentation for cosmetic reasons suffered complications within three years—for mastectomy patients the figure was 73 per cent and 27 per cent had to have their implants removed as a result. The FDA has a page on its web site devoted to photographs or illustrations of breast implant complications.[25]

  We list below some of the more common complications.

Capsular contracture

  4.2  Whenever a foreign object is placed in the human body, a fibrous capsule is formed around it as the body seeks to isolate and expel it. The capsule contracts apparently trying to squeeze out the foreign object. The breast can become hard, painful and inflamed and the implant can become displaced. Originally surgeons treated this by manually massaging the breast until the capsule fractures and the tension was released. This practice ceased to be acceptable in the mid-1990's when it was realised that this often caused the rupture of the implants contained by the capsule. Standard practice now is to open the chest, cut or remove the capsule and replace the implant.

  4.3  Capsular contracture was first reported in the UK in 1980 when around one third of women followed up had experienced this. Even then the surgeon was highlighting deficiencies in follow up in the private health sector.[26]

  4.4  The D of H advises that one in every 10 women with breast implants will experience painful hardened and/or deformed breasts as a result of capsular contracture.[27]


  4.5  This is the fracture of the implant causing leakage of the implants contents into the capsule and the chest cavity. There is clear evidence of a high incidence of spontaneous rupture as the implants apparently fail to cope with the expulsive forces placed on them by the body. Research shows that most implants will rupture over time. Some will rupture because of external trauma or damage during insertion. Because the implant is held in place by the fibrous capsule, a woman and her doctor may be unaware that the implant has ruptured. MRI or ultra sound scans may be required to demonstrate this. Research carried out by the FDA has also shown that after 10-15 years 80 per cent of women will experience a ruptured implant. Research carried out as long ago as 1991 showed all implants older than ten years were leaking or ruptured.[28]


  4.6  All implants leak as their contents can in appropriate circumstances pass through the permeable silicone envelope even though the envelope remains intact.


  4.7  As with any operation there is a risk of infection, which may required the chest cavity to be reopened, and the implant removed or replaced.

Migration of contents

  4.8  The body does not naturally excrete silicone. It appears that silicone can migrate through the lymphatic and circulatory system.[29] Silicone gel has been reported in the wrist and fallopian tubes in the groin.

  4.9  Soya is excreted but has to escape from the chest cavity first. There is no safety data on soya retained within the body and not excreted.

Interference with Scanning

  4.10  The presence of an implant can reduce visual clarity in the scanning process because it may produce a shadow; impede the transmissions of the x-rays etc involved or compress tissue making architectural distortions difficult to visualise. This may cause delay in detecting cancerous growths. The ill-fated Trilucent soya implants were marketed as having no impact on scanning and many women were attracted to this feature, some switching from silicone implants to take advantage of this.


  4.11  Implants are typically inserted through an incision in the fold underneath the breast but alternative routes are through the nipple or via the armpit. As with all operation sites some are slow to heal. Repeat surgery is usually undertaken through the same incision site to reduce scarring but scar tissue and keloid scarring may be unwanted side effects. Around one in every 20 women with breast implants may expect problems with their scars.[30]


  4.12  Some women will experience the creasing or folding of their implants often described as rippling. This may lead to rupture if the wall of the implant is weakened and in any event surgical intervention may be required to resolve the unwanted appearance.

Nipple sensation

  4.13  One in seven women may experience permanent loss of nipple sensation.[31] For others sensation may increase so the effect becomes unbearably painful.

Breast feeding problems

  4.14  According to a reputable American study,[32] breast implant surgery makes it less likely that a woman will breast-feed either because of inadequate milk supply or of concern at the unknown effects on the child.


  5.1  There has to be concern at the promotion of life-style enhancing breast enlargement by the use of prosthesis as opposed to those required medically for reconstructive purposes. However, the question may be how far the Government should involve itself in individual freedom of choice.

  5.2  A healthy woman agreeing to have breast implants needs to be informed that:

    (a) The implant is highly likely to create a capsule, which may harden and require surgery.

    (b) The implant is highly likely to rupture and require surgery.

    (c)  Most young women will require several operations over time[33].

    (d)  Each operation would involve the removal of breast tissue and scarring.

    (e)  Her breast will never look the same so removal without replacement may not be an option.

    (f) No implants have been subjected to long-term human safety trials.

  5.3  All of this takes place within an industry geared to making a profit in which the consultant may be a salesman and not a doctor; as stated above any doctor can apparently describe himself as a cosmetic surgeon; most patients (still!) trust their doctor and complications lead to more bills for the patient and therefore act as a deterrent to seeking prompt medical attention.

  5.4  In our experience a surprising number of women incur debt to finance the original operation and do not even tell their nearest and dearest that they have had the operation. When things go wrong both factors add to the distress involved. As well as a human tragedy when things go wrong there is usually a price paid by the state, whether through benefit payments, use of NHS or otherwise.

1   Exhibit 1 Back

2   Kessler DA. The Basis of the FDA's decision on Breast Implants. New England Journal of Medicine 1994; 330:1748-9. Back

3   Sancez-Guerro, Lang BMJ Vol 309 1 October 1994-Exhibit 1 (a). Back

4   D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information for women considering breast implants p3. Back

5   PL/CMO(92)1. Back

6   PL/CMO(93)2-Exhibit 2. Back

7   Evidence for an Association between Implantation of Silicones and Connective Tissue Disease MDD Report 92/42 D of H Feb 1993. Back

8   Evaluation of Evidence for an Association between the Implantation of Silicones and Connective Tissue Disease Medical Devices Agency Dec 1994. Back

9   This statement was plainly wrong. Back

10   Personal communication from Mr DC McNeil 18 November 1994-Exhibit 3 Back

11   Letter from McNeil to patient 7 November 1994-Exhibit 4. Back

12   Quoted in letter from Plastic surgeon PMO'Hare-Exhibit 5. Back

13   D of H 94/255 25 May 1994-Exhibit 6. Back

14   All women could register not simply those "who believe their health has been affected". Back

15   D of H Press release 97/125 Thursday 4 June 1997; 97/131 12 June 1997-Exhibit 7. Back

16   Silicone Gel Breast Implants July 1998. Back

17   21218 1P 80m Sept 00(CWP). Back

18   D of H press release 2000/0556 4 October 2000-Exhibit 8. Back

19   D of H Booklet 21218 1P 80m Sept 2000 (CWP) Breast Implants-Information for women considering breast implants p9. Back

20   FDA letter 28 February 1992-Exhibit 9. Back

21   Letter Harley Medical Group (undated-June 2000)-Exhibit 8a. Back

22   AN1999(01)-Exhibit 10. Back

23   MDA HN2000(05)-Exhibit 11. Back

24   MDA 2000 (07) and (08)-Exhibit 12. Back

25 13. Back

26   Wallace; British Journal of Plastic Surgery (1982) 35,374-5-Exhibit 14. Back

27   D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information for women considering breast implants p7 Back

28   de Camara DL.Rec.Surg.91:5 1993 828-34-Exhibit 15. Back

29   Kossovsky et al; Analysis of the surface Morichology of recovered silicone mammary prosthesis; Plastic Reconstructive Surgery 1984 71(6): 795-804. Back

30   D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information for women considering breast implants p8. Back

31   D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information for women considering breast implants p8. Back

32   National Academy of Sciences Institute of Medicine: Safety of Silicone Breast Implants, National Academy Press, Washington DC 1999 p197. Back

33   See D of H Booklet 21218 1P 80m Sept 00 (CWP) Breast Implants-Information for women considering breast implants p10. Back

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