KEEPING ABREAST OF IMPLANTS RUWENA KHAN

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1 KEEPING ABREAST OF IMPLANTS RUWENA KHAN Introduction The origins of plastic surgery, a medical speciality concerned with the correction or restoration of form and function, can be traced back to 800BC when reconstructive surgery techniques were being carried out in India 1. Incredible developments in this field have taken place over the centuries, including the development of facial surgery during World Wars I and II, to the extent that aesthetic plastic surgery where the end goal is, in its simplest form, the enhancement of appearance through surgical and medical techniques - is a commonplace occurrence and not simply the reserve of the rich and famous. A prime example of such cosmetic surgery which has hit the news recently is that of breast implant surgery. There are three types of breast implant used for mammoplasty, breast reconstruction and breast augmentation procedures: 1. Saline implant filled with sterile saline solution. 2. Silicone implant filled with viscous silicone gel. 3. Alternative-composition implant with miscellaneous fillers that are no longer manufactured. The most commonly used implant is that of type 2. There have been some five generations of silicone breast implant, each defined by common modelmanufacturing techniques. Since the mid-1990s, the fifth generation of silicone breast implant is made of a semi-solid gel that mostly eliminates filler leakage and silicone migration from the breast to elsewhere in the body. 1 MSN Encarta (2008). Plastic Surgery 1

2 Poly Implant Prostheses The latest scandal to hit the mammoplasty industry relates to breast implants produced by Poly Implant Prostheses ( PIP ). In 2010 France banned the implants produced by PIP due to the belief that there was an increased chance of the implants rupturing and leading to complications. In fact, it was found that the company had been using industrial grade silicone, normally used for fitting mattresses and computer parts, instead of medical grade silicone; the usage of this cheaper silicone saved the company approximately 840m per year. Worryingly, it is estimated that over 40,000 women in the UK have had breast implants produced by PIP since The Risks At the time of writing, it remains unclear what the exact risks are; the UK Government ordered a review because of conflicting data. In particular, cosmetic surgery group Transform, reported that the rupture rate was 7%. However, it should be noted that this rate was based on just 7 out of 108 patients Transform fitted with PIP implants since The French authorities have quoted a rate of 5% rupture risk. By contrast, the UK s Medicines and Healthcare products Regulatory Agency ( MHRA ) have quoted a rate of 1% which is similar to other implants. The latest news from the expert group behind the review is that they have been unable to establish if the rupture rate was higher for PIP implants than for others the data from the industry has simply not been good enough. However, it cannot be ruled out that there is a possibility that some of the PIP implants are toxic. A further potential risk is that of an increased risk of inflammation reaction, making removal more difficult. At this time, there is general acceptance that there is no increased risk of breast cancer from use of the PIP implants, although this was an initial worry. 2

3 The UK Government - Potential Next Steps On the 23 rd December 2011 the French authorities advised all its citizens who had had PIP implants to have them removed and that the French Government would pay the full cost of the procedure. They will not, however, pay for new implants. Germany and the Czech Republic have similarly advised the removal of the PIP implants. The UK Government, on the other hand, announced on Friday 6 th January 2012 that although patients who want their PIP implants removed will not have to pay for such removal on the NHS, removal was not recommended. The Health Secretary, Andrew Lansley, has stated the Governments advice remains the same, that there is not sufficient evidence to recommend routine removal. It is estimated that approximately 5% of the total number of patients who had had PIP implants received theirs on the NHS as part of breast reconstruction surgery. Indeed, the NHS has now provided a pledge, not only to remove the PIP implants, but to replace them without charge to those women who had the original treatment as part of postmastectomy reconstructive surgery. What of private health companies/practices? The Government initially strongly advised all such businesses to provide free removal of the PIP implants on the basis of a moral as opposed to legal obligation. Indeed, the Government warned that it would pursue private companies to waive charges for removal, as there are growing concerns that the taxpayer should not have to foot the bill for those who had paid privately for implants. Unsurprisingly private health companies have begun offering to remove PIP breast implants without charge. BMI Healthcare have said in a statement that they have decided that any patient who paid BMI Healthcare for their PIP implant surgery and who wishes now to have their PIP implant removed and replaced will be able to do so, at no cost. 3

4 The Legal Complications Although the MHRA initially approved the use of PIP implants, in March 2011 the MHRA issued an alert recommending that these implants should not be used, although, as noted above, they have not confirmed that the rupture risk is high. Further, neither the MHRA, nor indeed the Government, have gone so far as to state that the implants should now be removed. The Government s decision has perhaps alleviated many of the fears women may have had in relation to the use of PIP implants, but what would have been the legal scenario had the Government refused to assist with the removal of PIP implants? Duty of Care The patient s potential cause of action against the NHS would be in negligence, but if treatment had been sought on a private, fee-paying basis, as in the majority of these PIP cases, then there would also be a potential cause of action based on breach of contract directly against the treating clinician and/or private health company. The basic principles of contract law have to be considered in order to assess whether a relevant duty of care was owed to the patient what were the express terms of the contract, and what were the implied terms? The most significant term implied by law is that the medical practitioner will carry out the examination, diagnosis and treatment of the patient with reasonable care and skill 2, also analogous to the duty owed under tort. However, it is of importance to understand that such an implied duty does not equate to a duty to guarantee that the treatment will be a success. A doctor may, however, be regarded as having guaranteed the success of the treatment if they did so in express and unequivocal terms. 3 2 Supply of Good and Services Act 1982, section See further Eyre v Measday [1986] 1 All ER 488 4

5 The Standard of Care It was established in the case of Bolam v Friern Hospital Management Committee 4 that the test was that of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art. This Bolam test was reformulated by Lord Scarman in his judgment in Sidaway v Governors of the Bethlem Royal Hospital 5 : A doctor is not negligent if he acts in accordance with a practice accepted as proper by a responsible body of medical opinion even though other doctors adopt a different practice. When assessing whether a medical practitioner has satisfied the Bolam test, the following factors have to be considered: 1. The current state of medical knowledge (at the time of the act/omission complained of); 2. The specialisation of the practitioner; and 3. The status of the practitioner 6. These three factors aside, will any responsible body of opinion be sufficient? The House of Lords has expanded upon the Bolam test in the case of Bolitho v City & Hackney Health Authority 7 holding that the body of opinion relied upon must have a logical basis. A judge is entitled to find a practice unreasonable or irresponsible even though such conduct was unanimously accepted as proper by the experts. 4 [1957] 1 WLR [1985] AC For example, in Djemal v Bexley Health Authority (1995) 6 Med LR 269 it was deemed irrelevant that the medical practitioner in question was a senior houseman acting as casualty officer with only four months experience; the standard of care was that of a reasonably competent senior houseman acting as a casualty officer without any reference to the length of his experience. 7 [1998] AC 232; Lord Brown-Wilkinson emphasised the use of the adjectives responsible, reasonable and respectable. 5

6 Breach of Duty This brings us to the question of whether in instances where PIP implants were used in cosmetic/reconstructive surgery there was a breach of duty by the treating clinician(s)? The court would have to apply the Bolam test as modified by Bolitho and ask: Did this clinician act in accordance with a practice that was accepted as proper by a responsible, reasonable and respectable body of medical opinion? There is the initial question of whether the PIP implant should have been used at all. It could be argued that when France banned the PIP implant this was sufficient warning to the UK to similarly ban the PIP implant. However, the use of the PIP implant remained commonplace this falls back to the standard of care arguments in which the current state of medical knowledge has to be considered. At that stage, it is likely that any Defendant would seek to argue that there was a responsible, reasonable and respectable body of medical opinion that accepted the use of PIP implants in surgical procedures. The use of medical literature in this regard would be of assistance. Further, the MHRA had originally approved PIP implants for use. Nevertheless, certainly from March 2011, there would be a much stronger argument that the use of PIP implants was negligent following the warning provided by the MHRA. Even if the use of the PIP implant was not negligent per se, what of the failure to inform the patient of the potential risks of using these particular implants during the surgical procedure? In this country the doctrine of informed consent is not recognised as there is no absolute obligation to inform the patient of all possible risks. However, whether sufficient risks have been disclosed to the patient will be considered in light of the Bolam test. In the case of O Keefe v Harvey-Kemble 8 the Court of Appeal upheld a decision that the Defendant surgeon had failed to provide the Claimant with sufficient information about her desired breast augmentation surgery and the relevant associated risks. 8 [1998] 45 BMLR 94 6

7 As noted above, even at the time of writing the Government s review has been unable to come to any clear conclusion as to the increased risks or otherwise of the use of the PIP implant. Barring the standard advice that should have been given to any patient as regards rupture and other risks following such cosmetic/reconstructive surgery, it is unlikely that the court would find that the patient had not been provided with sufficient information at the material time if there was an omission of advice in relation to the use of the PIP implant when particular evidence regarding PIP implants was unavailable. Causation and Remoteness Even on the presumption that breach of duty could be established, it would have to be demonstrated that not only was there foreseeable injury, but that there was a causal connection between the two. If there had indeed been any rupture or other injury due, on the balance of probabilities, to the use of the PIP implant then such negligence would be a cause of the subsequent injury. If there were several concurrent or successive causal factors contributing to the patient s injury, in clinical negligence cases it has been established by the House of Lords that the patient would have to demonstrate that the negligence had actually caused or contributed to the injury; it would not be sufficient to show that the negligence had increased the risk of injury 9. This contrasts with the employers liability cases of McGhee v National Coal Board 10 and Fairchild v Glenhaven Funeral Services Ltd 11 where it was held that a material increase in risk of injury was sufficient to establish causation. 9 Wilsher v Essex Area Health Authority [1988] 1 AC [1973] 1 WLR 1 11 [2003] 1 AC 32 7

8 Conclusion The primary cause of action would have been against PIP directly for the defective and negligent manufacture of the breast implants. However, the company has now gone into administration. A Department of Health spokesman has said: Private providers have legal obligations to their patients. The NHS will offer a package of care for its patients, and we expect the private sector to do the same. The matter is clearly not as straightforward as espoused. Had the Government not stepped in and required the NHS to provide free removal of the PIP implant and put pressure on private health companies to do the same, whether there would have been a legal obligation to have done so is unlikely. Nevertheless, the question of legal obligation would primarily have been dependent upon when the procedure took place and whether a responsible body of opinion at that time, with a logical basis, would have accepted the use of the PIP implant as proper. The correct view would appear to be that in reality there is a moral obligation on the relevant treating clinics and clinicians to remove the PIP implant, together with business common-sense, but no legal obligation to do so. This further provides some reasoning as to why pressure is not being put on private health companies to also replace the breast implants. That is not to say that any injury that is caused as a result of a negligent act/omission during the treatment of a patient undergoing breast implant or other cosmetic surgery has no cause for redress but the use of the PIP implant in itself may be unlikely to lead to legal redress 12. RUWENA KHAN Zenith Chambers 7 th January Johnson v Fourie [2011] EWHC QB (QB) a record award of over 6 million was made in a cosmetic surgery negligence claim where liability was admitted by the Medical Defence Union on behalf of the negligent surgeon who damaged branches of the claimant s right facial nerve and caused disfigurement of the left breast which was also operated on at the same time. 8