Select Committee on Health Minutes of Evidence

Memorandum by Paul Balen Freethcartwright Solicitors (B 15) (continued)


  6.1  It may be thought that the object of Government licensing is to certify officially that a product has been thoroughly tested and is safe. If not one may ask what is the purpose of a licensing procedure and the Government's involvement in it?

  6.2  Most consumers would think the CE European quality mark denotes Government approved safety. It appears that it does not. In fact in Europe, medical devices are not licensed by a regulatory authority. Instead they carry the CE marking purely to draw attention to the manufacturers' claim that the device is safe and fit for its intended purpose and meets all the requirements of the Medical Devices Regulations.

  6.3  We believe that the introduction and use of the CE Mark as an aid to harmonisation of standards in the EC may have had the effect of reducing the standards in this country and therefore reducing the safety of products supplied to consumers.

  6.4  The CE mark does not in any way represent a guarantee of safety. We believe that consumers believe and require that such marking should represent such a guarantee. The MDA acts on behalf of the Secretary of State for Health. We believe that the MDA as the UK national authority should exert responsibility for checking claims of safety before authorising use and not after, particularly when that product is to be implanted into the human body.

  6.5  Breast implants are in a medium risk category where that claim is assessed and endorsed by independent companies who offer commercial certification facilities. These companies are known as Notified Bodies. The granting of a CE marking means that the product can be freely marketed anywhere in the European Community without further control.

  6.6  The MDA appears to have responsibility for supervising Notified Bodies in the UK. We do not believe it has any responsibility in the rest of Europe. This means that the UK is bound to accept products with CE marks granted by notified bodies anywhere in Europe over which it has no control.

  6.7  The commercially driven system has transparently failed to deliver a substantiated guarantee of safety which consumers are entitled to expect, as the frequent banning of CE marked products, particularly in the breast implant field illustrates. Consumers are entitled to believe that too often they are being treated as human guinea pigs, and that later banning of products and criticism of manufacturers' safety information smacks then of shutting the stable door after the horse has bolted.

  6.8  Notified Bodies can be selected anywhere in Europe by manufacturers seeking approval for their product. Commercial sensitivity means that information is hard to come by, but the risk to consumers is that manufacturers seeking a foothold in Europe could be tempted to select the commercial organisation it concludes is the "weakest link" is certify its product.

  6.9  Notified bodies as profit centres are also likely to be under pressure not to fail products thereby risking a reduction in their income. The responsibility of those companies who are accepted as Notified Bodies is yet to be tested. It is odd that they can be in a position of overruling national device regulatory processes. This is recognised by the MDA which has apparently secured a review of the operation of the European Directive for Medical Devices.

  6.10  It is understood that measures under active discussion include the establishment of a European Notified Body Oversight Group and the reclassification of most medical implants, including breast implants, into the highest risk group. This would afford them the most vigorous controls allowed under the Regulations and, for example, require the Notified Bodies to assess the manufacturer's design dossier for each device. It is astonishing that implants which are used for major operations for large numbers of women and which have a long track record of safety concerns are not already subject to that kind of rigorous review. We would ask why that state of affairs was allowed to exist.

  6.11  In addition, at the request of the European Parliament, the European Commission is preparing a document that outlines specific measures to ensure the reliability of breast implants. We believe that these are likely to follow the recommendations of the 1998 UK's Independent Review Group.

  6.12  We are also concerned at the lack of public accessibility to Notified Bodies. A simple request for a copy of the declaration of conformity submitted to the Notified Body responsible for the licensing of the Trilucent implants was met by the response:

    "as the declaration of conformity is a document which is issued by the manufacture of a medical device himself, you have to ask the manufacturer for this document. Furthermore we are not entitled to release any document from a conformity assessment procedure to any person except the manufacturer and the competent authorities.[34]

  6.13  We believe that public accountability requires free access to this information parallel to the Freedom of Information provisions in the USA. Commercial sensitivity must take second place to safety considerations. In any event the single biggest users of freedom of information applications to the FDA in America are allegedly the main pharmaceutical companies.

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

  6.15  In America the FDA now requires all manufacturers to submit a Pre-Market Approval application in order to determine whether implants are safe for continued sale. As a result, for example, the FDA ordered that manufacturers of PIP saline implants cease selling these implants in the USA by May 2000 because it did not have sufficient trial data of patients two years post surgery.

  6.16  In this country 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. Trials should be conducted under the usual ethical and professional standards so that women know they are part of a trial. At present it appears that the general population of women has been treated as unknowing guinea pigs in the use of breast implants.

  6.17  In Australia, for example, a clinical trial of Hydrogel implants was announced in 2000 and 2001 to allow for a full commercial launch. The purpose of the trial is to evaluate the prosthesis, to ensure it is safe and conforms to Australian regulatory authority. This evaluation has to be carried out before wider use is licensed.

  6.18  The laxity of the UK/European position is demonstrated by this description taken from a reputable US website before Trilucent implants were banned in the UK:

    "An American company offers the soy oil breast implants done in England. The package offer involves travel to England. However this does not guarantee its safety by American standards[35]."


  7.1  It would also appear that the FDA has an aggressive monitoring process which includes the inspection of manufacturing plants of companies supplying the US market wherever in the world they are located. An example, which should cause concern in the UK, is what happened to Biosil Ltd.

  7.2  Although Biosil has manufacturing plants in Cumbernauld in Scotland and Ashy de la Zouch in Leicestershire it, like its distributor Nagor, is an Isle of Man company owned by Americans which supplies silicone and saline implants to both UK and US markets.

  7.3  On two occasions in 1996 and again in 2000[36] the FDA has banned its products from the USA on the grounds that inspection of its premises in Cumbernauld in Scotland has shown substantial deficiencies potentially leading to the supply of adulterated products. The warning letters have been available, posted on the FDA website. Biosil has maintained its supply to the UK market throughout with no apparent intervention by any Government agency. Indeed it is somewhat unclear whether the MDA have any remit equivalent to the action taken by the FDA. The suspicion is that the MDA was taken by surprise by the FDA inspection and action.

  7.4  In the course of our enquiries we have seen uncorroborated information obtained anonymously from a Biosil employee describing how the company in its manufacturing plant allegedly used out of date materials; patched up holes in implant shells and changed manufacturing specifications to allow failed implants through quality control.

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

  7.6  Implants do fail and some fail very early after insertion. Almost inevitably this leads to further major surgery. Whilst some companies are amenable at least to supplying replacement implants, compensation for the pain, suffering and medical expenses suffered by these women is often refused. As we review below, the law may create difficulties for women seeking to have put right what has gone wrong. Often the supplying companies will blame the surgeon or simply point to such episodes as being an inevitable consequence of breast implant surgery challenging the women concerned to prove what has gone wrong with their implants. Little or no information is available on the processes inside the manufacturing companies. Defects in those processes and in quality control may account for the high number of early failures of breast implants.

  7.7  Statistics as to failure rates and their cases are hard to come by. The breast implant registry is voluntary. Notification of defects is voluntary.

  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.

  7.8  All this would enable better monitoring of implants, enable regulators to pick up concerns earlier, and patients and doctors to make a more informed choice as free as possible from marketing, advertising and commercial considerations. This would parallel the introduction of hospital league tables and the monitoring of doctors' performance, which are now beginning in the NHS.


  8.1  The Consumer Protection Act 1987 was designed to implement the European Product Liability Directive 85/374.[37] The Directive predicates that to balance the influence of multinational corporations supplying goods across international boundaries, the consumer needs to be protected by the creation of a strict liability regime whereby compensation is paid for injuries suffered as a result of a defective product regardless of proof of fault. Manufacturers can protect themselves through insurance and claims against other parties they believe may have been responsible. The test for defective product is that:

    "the safety of the product is not such as persons generally are entitled to expect.[38]

  8.2  The Act has been poorly used and severely criticised.[39] A detailed analysis is probably outside the scope of this paper but a breast implant case of ours, Foster v Biosil[40] illustrates the difficulties experienced by consumers.

  8.3  In this case a woman's two implants ruptured or leaked only a few months after insertion necessitating further surgery to replace each implant one after the other. The supplying company denied liability. It blamed the surgeon alleging that he must have torn or cut the implants when inserting them. The surgeon gave evidence denying this and this part of the defence was dismissed. However, the trial judge, Cherie Booth QC, held that while persons generally would not have expected implants to rupture or leak in this way the consumer claimant still had to prove what the defect was. In this case there was no way of proving why the implants had failed or what the manufacturing defect had been. Consumers will rarely be able to do this. Breast implant recipients will most likely be unable to do so, particularly if the implant has been ruptured, destroyed or disposed of.

  8.4  To give protection to consumers it should be sufficient to demonstrate that a product was not as safe as expected (as per the wording of the Act and Directive) without identifying the cause of the defect. Under the Directive the supplying company still has the ability to seek indemnity from another person in the supply chain[41] but the concept is and should be that the manufacturer is directly liable to the consumer. If there is a battle it should be between the manufacturer and other party—in this case the surgeon. Alternatively it should be for the supplying company to demonstrate that there was no defect. In other words, the onus of proof of causation should be reversed. Only then will consumers be protected in cases where products fail and cause injury but the consumer does not know the mechanism of failure.

  8.5  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.

  8.6  After all, the act is the Consumer Protection Act not the suppliers' protection act. It should therefore protect consumers not suppliers.


  9.1  Immediately the Hazard Notice was published recommending removal the supplying companies, which had up until then resolutely denied legal liability whilst paying some medical expenses and some compensation in individual cases, entered into negotiations with us on behalf of claimants in order to devise a settlement scheme. The aim was to avoid a lengthy and costly court battle. For our part we were seeking reasonable compensation to be paid to affected women as quickly as possible. After 5 months of negotiations a settlement scheme [42]was announced and the first payments under that scheme have now been paid.

  9.2  The payment of medical expenses promised by the Hazard Notice and compensation promised under the settlement protocol should not disguise the real distress and difficulties experienced by many women.

  9.3  When the MDA announced its recommendation that women with Trilucent implants should have them removed, it announced that it had agreed with the responsible company AEI Inc that AEI would bear responsibility for medical expenses. Women were told that the company would cover all medical expenses. [43] The Hazard Notice was accompanied by a Statement and an Information sheet to be given to affected women. Women were told that:

    "The company that is responsible for these implants, AEI Inc, has agreed to pay for treatment that is needed. If you do have Trilucent breast implants and decide to have them removed or replaced, you will not have to pay for this".

  9.4  The company set up the Trilucent Care Centre managed by BUPA, which supervised the consultation, implant removal, replacement and follow up care costs by requiring surgeons to contact them for authority. It also devised, without consultation, a scale of charges, which the company would find acceptable.

  9.5  The weakness of this procedure is that the MDA and the responsible company are dealing with a commercial fragmented private sector. Furthermore as we illustrate the Company's policy did not meet the commitment announced by the MDA.

  9.6  As could have been anticipated, a minority of surgeons and hospitals saw no reason to alter their standards commercial procedures. For them the patient was a customer who would be responsible for the hospital and the surgeon's charges at whatever level the hospital or surgeon decided to charge. In a few , but far too many cases, surgeons and hospitals refused to accept the fees set as standard by the Trilucent Care Centre as a result of which women, who were already naturally distressed by the whole experience found themselves pawns in a pay dispute. Some women received solicitors and bailiffs' letters; some women were forced to sign agreements under threat that their operations would not proceed that day unless they guaranteed payment; some surgeons threatened the women directly.

  9.7  This demonstrated an alarming failure by the Government through the MDA and the D of H to understand the nature of the profession with which it was dealing and to ensure that the patients had the protection that both the D of H and the MDA made it clear they expected them to receive. No system was built into the scheme arranged by the MDA for disputes to be resolved. Some plastic surgeons displayed little, if any, caring attitude towards their patients. One in particular insisted on speaking to the writer about his fees and when learning he was engaged, demanded that the phone call or meeting be interrupted on the grounds that "he was a plastic surgeon". Even BUPA hospitals disputed some levels of fees allowed by the BUPA run Trilucent Care Centre, the internal BUPA dispute being explained away on the grounds that BUPA was in fact a series of totally separate organisations.[44] None of this was any comfort to the vulnerable patients. Some patients found their surgeons refusing to provide the confirmation of their medical position which was required to enable them to claim compensation, on the grounds that the company had not paid them.

  9.8  We recommend for the future that when a product is withdrawn, the Department of Health 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.

  9.9  We further recommend that the MDA/D of H produce evidence that the supplying companies 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.

  9.10  As can be seen from the list of complications arising from breast augmentation surgery, the D of H and the MDA must have anticipated that the mass removal of implants would lead to a large number of women suffering further complications for which medical treatment was required. It is clear that the D of H or MDA agreed no facilities with the company for the payment of these expenses.

  9.11  Women therefore who experienced capsular contraction and other problems with their replacement implants—complications which they would not have experienced but for the necessity to have their Trilucent implants replaced following the MDA notice of 6 June 2000, found themselves having to pay for treatment or going without treatment because the Trilucent Care Centre refused to pay for further treatment. TCC claimed that the women should first look to the suppliers of the replacement implants, even though there was no evidence and would probably never be any evidence, of a defect in the replacement implants.

  9.12  Again, no system of dealing with these problems was set up. Instead, the women's only recourse was to argue long and hard with the company through its solicitors, leading to greater distress and concern for already worried women. Legal action may not provide payment up front, so women are faced with paying for further operations themselves or not having medical treatment that they are advised to have. If they do have that treatment and pay for it, they then have to claim the cost back first, from AEI Inc as responsible company for Trilucent implants, and if it denies responsibility, joining into any claim against the suppliers of the new implants (quite conceivably AEI's holding company which also supplies McGhan silicone implants) or if the company alleges that the surgeon was negligent, the surgeon himself.

  9.13  We recommend that in future cases, and in this case, the D of H 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.

  9.14  As none of this would have arisen without the removal operation caused as a result of the defective Trilucent implants in the first place, we recommend that in cases in which an immediate decision as to the liability for costs of 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 or licensing processes.


  10.1  This problem was further exemplified by the later suspension of supply of Hydrogel implants. In December 2000 when the announcement was made[45], the MDA made it clear that there was no evidence of a health hazard, simply concern at deficiencies in the manufacturers' safety data. This distinction was of little comfort to women who had those implants, some of whom had received Hydrogel implants as replacement for their silicone and/or Trilucent implants which had been the subject of previous health scares or bans. Women were clearly going to be concerned that their implants had been banned for use for future patients and that the health position was currently under investigation.

  10.2  The MDA announcement stated:

    "Women who think they may have Hydrogel implants and are concerned should contact the surgeon who carried out the operation, or their GP . . ."

  10.3  Women were told that there is no evidence at present to recommend explantation; that if they were worried they should seek a consultation with their surgeons and that:

    "The Department of Health is currently discussing reimbursement for clinical consultations with the manufacturer."

  10.4  In fact, when we made enquiry of the manufacturers on behalf of worried women, PIP/Cloverleaf denied any responsibility while Novaguard offered to pay £100 towards the cost of a consultation, but only if this was accepted in full and final settlement of all claims both now and in the future—a condition which was clearly oppressive and incapable of acceptance.

  10.5  It was obviously unsatisfactory that all that was done, as the announcement indicated was that contact was being established with the manufacturers to sort out payment for the consultation fees that many affected women would incur. Presumably it was the wish of the Department of Health and the Medical Devices Agency that no women would be charged for having their implants checked in the light of the warning notice, but neither manufacturer was prepared to provide this and one—Novagold—as we have seen, did offer a small financial payment but only on the most onerous terms which it had to have known that no woman would be advised to have accepted. Presumably the MDA knew this when the announcement was made but does not appear to have resolved this problem.

  10.6  Furthermore we have discovered that Novagold expressly did not accept the MDA announcement. It stated that:[46]

    "our company . . . do not understand the need for the device Alert (MDA 2000(08)), indeed our company believes that the action the medical devices agency took was both inappropriate and unjustified and therefore in breach of article 8 of Council directive 93/42/EEC.

    . . . We do not advise that patients seek medical advice and clearly there is no question of explantation being necessary"

  10.7  This demonstrates a total lack of understanding of the effect of the MDA announcement on women who had their company's products; a total lack of sympathy for their position and appears to place innocent women as pawns in a dispute between the MDA and the company about which both the D of H and MDA have been totally silent. It should not be left to us as the women's lawyers to try and resolve this. In any event the law is often a blunt weapon in such circumstances. What the women need is medical advice without cost, not the possibility of including those medical costs in a claim at a later date.

  10.8  The MDA announcement suggested that it was made with the agreement and co-operation of the suppliers. This does not seem to have been the case. The consumers appear to have been left exposed.

  10.9  PIP of France, the other manufacturers of Hydrogel implants simply stated:

    "at this day, it is not proved that our products are defective or dangerous. Then, our liability is not engaged [47]


  11.1  Even though the Trilucent implant system was one of the more advanced registration procedures used in implant supply, one of the other problems, which has emerged with all devices, is the lack of a failsafe method of product identification. Here the problem appears to be worse in the NHS. Whereas private clinic doctors tended to ensure that patents registered their Trilucent implants with the manufacturers, the NHS did not appear to be geared to arrange this. Hence the supplying company appeared unaware of the patients who received their implants in the NHS where they were occasionally supplied to victims of breast cancer who had undergone mastectomies.

  11.2  Some women are uncertain as to which implants they received or, where there is more than one supplier of the same type, the identity of the supplier of their particular implants. When faced with the notices issued by MDA it is essential that women can readily identify their implants and their source.

  11.3  We have often been handicapped by not being able to find out the identify of implants inserted in a client. Some clients in the American settlements have been unable to claim compensation because the identity of their implants cannot be verified.

  11.4  We even have an example of a woman having paid for Trilucent implants, and therefore having to have them removed, discovering on awaking from the anaesthetic after the removal operation that she had had silicone and not Trilucent implants. She had therefore undergone an unnecessary operation and had possibly been tricked by the implanting clinic/doctor, as Trilucent implants were generally more expensive than other breast implants.

  11.5  Other women complain that they were unaware of the MDA announcement. Some clinics efficiently followed up women; others did not and in any event with an increasingly mobile population contact with some recipients were always going to be difficult

  11.6  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 patients medical records.

  11.7  Such systems would aid identification; monitoring of complaints/defects and notification of warnings/withdrawal etc.


  12.1  Failure of the licensing process as exemplified by the Trilucent saga leads to human tragedies. The following random comments from some of our clients ought to drive the point home. Some face the same traumas again following the ban on Hydrogel implants:

    1.  "I am heartbroken. There is not a day that goes by that I am not in pain and that only reinforces the unhappiness that I now have due to the removal and replacement of what I was more than happy with."

    2.  "As you can imagine with just 2 days to go before surgery I am very nervous and tearful"

    3.  "I decided after many hours of discussion (and tears) with my husband to terminate my pregnancy. I really could not bear the thought of having a baby that may be handicapped in some way due to the Trilucent implants. My replacement operation is booked for Tuesday. Wish me luck."

    4.  "I was separated from my husband and had to endure all the travelling and emotional upset on my own. I also had a small child to look after I have just completed university and have a job. I have paid for university with loans, and now have approximately £10,000 worth of debt. I am a single parent of an already traumatised child who has watched me through operation after operation this is surely a further punishment to us both who have not consciously chosen this path."

    5.  "I had a court hearing . . . I had to pay rent and arrears and I've missed a few weeks partly because I took time off work to have my breast done and the money I lost would have covered three weeks rent. I have been served with an eviction notice. Rosie (one of our secretaries) doesn't know me at all and she was concerned and she listened to me blubbering on, even if you cannot help I would just like to thank her."

    6.  "I am in the same position I was in 1992 having to contemplate life without a bust. My husband has never seen me without implants despite reassurances he will love me no matter what I don't particularly love myself at this moment in time. I am writing this two days after my operation feeling very low, let down, my body in ruins. If I had had any other implants I would be sitting on a beach, potentially pregnant enjoying the sum . . .Unfortunately we have taken two weeks off work, my husband, a GP, and myself, a health visitor, to try and put our lives back together baby less and boobless. Please help."

    7.  "It was an inconvenience in the first place not to mention having to wait a month to have the operation and the stress and worry of what the implant has done to my body. I am self-employed and do not have an income as I am a hairdresser and clients are waiting for me to return to work. My partner has left me and my two children with all the stress and upset this has caused. Everything has suffered due to this horrendous experience . . . I do hope you can help me."

    8.  "I am a widow with two young sons" . . .

    9.  "I have gone from feeling confident and happy to the complete opposite."


  13.1  We append some random examples of the chaos caused by the failure of the Government's assurance that women will not have to pay the medical expenses arising from treatment following the MDA Hazard Notice of 6 June 2000. The examples are typical and are extracts from relevant letters or e-mails. The party sending the letter e-mail is identified in brackets at the end of the extract.

Example 1

  St Anthony's pricing for each Trilucent patient differs immensely as their invoicing includes items right down to the last suture! Some patients therefore incur more than the fee schedule set out by the TCC.

I have recently been advised by Steve Holland, account manager, St Anthony's, Hospital, about four patients who have incurred more costs than the TCC fee schedule. None of the extra payments concern post op complications, as far as I am aware.

  Steve Holland is well aware of the limit to which TCC are prepared to go in terms of fee schedules. Therefore in every case he insists that the patients sign to say that they will personally settle costs above the ceiling amount. Unfortunately, Steve Holland does not explain to these women that there will undoubtedly be a shortfall. Whilst patients sign the document it seems that they don't really expect to pay anything. That is why it comes as something of a shock to them when they receive an invoice.

  The patient has signed an agreement to say that she will pay the difference. AEI and the TCC whilst willing and able to offer these women an alternative venue/surgeon cannot mandate this nor can they control/manage how hospitals enter into contracts with patients. The issue then would seem to be between the hospital and the patient. (AEI).

Example 2

  C has suffered psychologically with the problems over her breast implants...the further surgery will aid her mental state. (GP)

  C attended for consultation again having previously expressed some concern about the appearance of her breast and once again stated that her breasts have become saggier since she had her Trilucent implants removed. She does indeed have a significant degree of ptosis. . . . I have advised C that the only way that her nipples can be lifted is by carrying out a mastoplexy. . . .

  C told me that she has already spoken to the Trilucent Care Centre who said that she required a letter from her surgeon and that is why I am writing to you to add support to her request that this should be considered favourably for funding by the Trilucent Centre. (Plastic surgeon)

  TCC . . . have declined funding as the surgery is required for aesthetic reasons. (AEI's solicitors)

Example 3

  . . . these implants were exchanged following which she developed a haemotoma in the right breast requiring secondary surgery on 24 July 2000. In September of last year she developed a lump in her left breast and I thought it prudent to arrange an ultrasound scan to investigate this. The invoice for this service was sent to AEI and I gather there is some dispute about them paying. Over the last month she has developed capsular contracture (hardening) of the right breast which is probably related to the haemotoma. This is of course a risk after any breast augmentation but it is becoming increasingly more common after exchange of breast implants. It is likely that this lady will need further surgery and again AEI have stated that they are not responsible for such revisional surgery. (Consultant)

  May I refer you to our policy with regard to post-operative complications in general. AEI are committed to reimburse immediate post-operative complications, for example haemotoma and infection, up until removal of the patient's sutures or occasionally for a longer period at the discretion of the company. To this end we have prepared a policy statement which I hope will make our position clear as follows: AEI Inc have agreed to cover the reasonable costs associated with the removal of Trilucent implants and their replacement if desired. They will also support any complications arising as a result of surgery, prior to the post-operative consultation.

  Thereafter as you will appreciate there are a number of inherent risks associated with breast implants (including capsular contracture). Whilst it is entirely appropriate for AEI Inc to take responsibility for the costs associated with the surgery to remove and replace the Trilucent implants, it would not be reasonable for AEI Inc to also have to assume liability for all risks on an ongoing basis and associated with other implants. As such complications subsequent to the post operative consultation should, if appropriate, be pursued with the manufacturer of the current implant, as is normal practice within the industry. In conclusion, following care full consideration of your letter we do not feel that they fall within our reimbursement remit. (AEI Inc).

Example 4

  A student who experienced complications and who had to stay a second night in hospital.

    . . ." X was booked into the hospital by the consultant as part of the Trilucent Care Programme. We had received the relevant paperwork from the centre relating to the claim and payment process, which I have checked personally and thoroughly. I note that there appears to be no indication of any financial limit on payment from the Trilucent Care Centre, which quotes on page nine that "the Trilucent Care Centre will pay `customary and resonable' expenses towards these costs". As there appeared to be no limit on payment we are under no obligation to negotiate with you prior to admission and the operation went ahead as normal. All the paperwork was explained to X on arrival and as no shortfall was expected on the account, X was advised only of her liability for any additional personal expenses. X stayed for two nights and again it is not documented that the patient should have a limit in their length of stay, only that "the patient will require at least a one night stay" page nine.

      After discharge the account was calculated and sent in accordance with your guidelines and it was only then we received a letter from yourselves dated 5 September which outlined the maximum limit payable on the account of £1,000 . . . the account remains outstanding. As there was no indication at any stage of a limit on payment towards the costs of this operation, it is unreasonable to expect the hospital or the patient to pick up any shortfall on the account. I must assure you that all our charges are extremely competitive compared to other similar independent hospitals, especially bearing in mind that we as a charitable organisation remain a non-profit making organisation and in consequence keep all costs to our patients as low as possible. (Hospital to TCC)

      "Trilucent paid £1,000 of the hospital's invoice . . . which leaves a shortfall of £957.55 due from your client. Despite request by the hospital, payment of its fees has not been forthcoming either from your client or from Trilucent.

      We understand you are seeking payment from Trilucent. However, this does not affect your client's liability to pay the balance of the hospital's fees, which are long overdue.

      We therefore request that your client sends this firm a cheque for £957.55 within seven days . . . failing which it is regret that our client has instructed us to issue proceedings. (Hospital's solicitors to Freethcartwright 5 March 2001)

Example 5

  I proceeded to explantation . . . both Y and I understood that Trilucent would be furnishing any accounts generated from this process. . . . As you will see . . . account number 1424 has a shortfallof £645.00. (Consultant)

  Thank you for your invoice 1424 (£1,600)...Payment of £955 will follow shortly in settlement of this account. A standard fee schedule for this surgery has been formulated...payment of the account is within this schedule. (TCC to surgeon)

Example 6

  I enclose a further invoice from Mr G. As I explained his business manager telephoned Friday warning me that Mr G would be seeking payment of the outstanding £500 through a debt is not my custom to receive services and not pay for them . . . according to Annex 6 of the document issued by the Medical Devices Agency in June 2000, AEI are responsible for all medical bills. . . . Because of the dispute with Mr G I felt unable to attend a post-operative consultation with him. . . . If there are any factors that the surgeons had been told to advise patients then I am unaware of them and this increases my anxiety. To be bombarded for money and be "piggy in the middle" has at times reduced me to tears.

  I feel very strongly that the additional bill submitted by Mr G was reasonable to rectify the damage caused by the Trilucent implant and that AEI should have paid Mr G in full. (Patient to Freethcartwright)

  In a private plastic surgical pratice all patients who are self-funding or have an insurance excess are asked to settle their account in advance. Normally one would not proceed to surgery until the account had been settled. I confirm that if my account is not fully settled I will pursue Mrs X for the balance. (Mr G)

  AEI/TCC will not be providing the additional monies charged by the surgeon...this is a matter between the surgeon and the patient. (AEI)

Example 7

  The Trilucent Care Pprogramme was set up to assist patients and doctors through the removal of Trilucent implants and reimplantations if desired in response to the hazard notice by the Medical Devices Agency.

  Whilst I appreciate this lady's position we have honoured our duty to remove the soya implants due to the potential health risk which was only a precautionary step and as such I have to inform you that we are unable to assist with further funding in this case.

  However if there are any problems with the new implants we would suggest you contact the manufacturer of the new prothesis. (TCC to surgeon who requested funding for further operation due to capsular contracture)

Example 8

  "The hospital has remonstrated with the care programme to ask it to pay our invoice in full, as our charges are reasonable and customary. They have declined to pay more, and I am afraid that I do have to ask you to settle this balance, in line with the written undertaking you signed at the time of your admission. It seems that you will have to take this matter up with Trilucent in order to recover the whole cost of your treatment." (Hospital to patient)

March 2001

34   Letter TUV Product service to freethcartwright 24/10/00. See also description of TUV's services-Exhibit 16. Back

35 referring to Surgical Advisory Services of Florida. Back

36   24/12/1996; 08/05/2000-Exhibit 17. Back

37   Exhibit 19. Back

38   S3(1) Consumer Protection Act 1987. Back

39   See National Consumer Council Report PD 451D4195 Unsafe Products Nov 1995 "The 1987 Consumer Protection Act has failed consumers and action needs to be taken to make it work"-NCC press release-Exhibit 18. Back

40   Unreported City of London County Court April 2000; Cherie Booth QC. Back

41   Article 8. Back

42   Protocol in Appendix 2-clients Newsletter and Solicitors Bulletin. Back

43   See MDA announcement 6 June 2000. Back

44   BUPA letter 1-2-01 -Exhibit 20. Back

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

46   Novamedical letter to freethcartwright 20/12/00-Exhibit 21. Back

47   PIP to freethcartwright 9/02/01 -Exhibit 22. Back

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