Consent to medical treatment

1. Introduction and background
1.1 Objectives
This section sets out the law which applies in the UK concerning consent to medical treatment, and deals with the application of that law to women who undergo surgery for breast augmentation. On the assumption that only women who are in possession of the necessary competence to give consent are likely to be seeking treatment, the paper does not consider the legal position of incompetent women. The paper explores the wider context and concludes with recommendations as to the consent requirements for women who are to undergo breast augmentation with silicone gel breast implants.

1.2 A working definition of consent to medical treatment
"Consent is the voluntary and continuing permission of the patient to receive a particular treatment based on an adequate knowledge of the purpose, nature and likely risks of the treatment including the likelihood of its success and any alternatives to it. Permission given under any unfair or undue pressure is not consent." (Department of Health 1993).

Consent to medical treatment may be oral or written, express or implied. For the purposes of surgery it is usual to obtain written consent from the patient except in an emergency. Standard consent forms are routinely used for the purpose of recording patients' consent, and these are useful for evidential purposes in the event of a dispute, as proof that consent was obtained.

Some surgeons performing breast implant surgery provide their patients with detailed written information about the operation and the risks associated with it. However, one matter of concern is that it appears from the evidence presented to the Independent Review Group that there is no uniformity in the approach taken to patient counselling, and that in some instances patients are given far too little information about what to expect as normal both in the immediate post-operative period and in the long term. It appears that very few patients are informed about the more unusual risks associated with breast implants.

1.3 The purpose of consent
In the case of Re W (A Minor) (Medical Treatment) (1992) 9 BMLR 22, Lord Donaldson MR identified the following purposes of the obtaining consent to treatment. His exposition can be summarised as follows:

• The clinical purpose of consent is to enlist the patient's faith and confidence in the efficacy of the treatment. This is a major factor in contributing to the success of the treatment.
• The legal purpose is to provide those treating patients with a defence to a criminal charge of assault or battery, or a civil claim for damages for trespass to the person. However, it does not provide them with a defence to a claim that they have negligently advised or counselled a particular treatment or carried it out in a negligent manner.

Thus the notion of consent to treatment is essentially a very practical issue, and is advantageous to both doctors and patients.

1.4 Ethical considerations: The right to self-determination
The fundamental ethical principle of the right to self determination was stated by Mr Justice Cardozo in the United States case of Schloendorff v Society of New York Hospital (1914) 211NY 125 when he said:

"Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages".

This principle underpins the common law concerning consent to treatment in the UK.

In Re T (1992) 9 BMLR 46, Lord Donaldson set out the position as follows:

"An adult patient who suffers from no mental incapacity has an absolute right to choose whether to consent to medical treatment, to refuse it, or to choose one rather than another of the treatments being offered...This right of choice is not limited to decisions which others might regard as sensible. It exists notwithstanding that the reasons for making the choice are rational, irrational, unknown or even non-existent".

UK law recognises the absolute right of a patient not be treated against his or her will, and not to be treated in the complete absence of consent. However, the judges in the UK have not developed a full doctrine of "informed consent", such as that which exists in the US and other jurisdictions, requiring the patient to be given full information about all the material risks and alternative treatments which are available.

2. The legal framework
The law concerning consent in the UK has been developed for the most part by the judges. There are some statutory provisions dealing with consent in the context of children and mentally incompetent patients, but these are beyond the scope of this section.

One of two civil actions might be available in circumstances when consent is deficient. These are the actions for trespass to the person (assault and battery) and the action for negligence.

2.1 Trespass to the person
Assault and battery are forms of the civil action of trespass to the person. They are also crimes, though it is be very unusual for criminal proceedings to be brought against a doctor who treated a patient without consent.

Assault (putting a person in fear of an immediate battery), usually accompanies battery as a matter of course. The tort of false imprisonment may also be committed. for example, where a patient is anaesthetised or detained in hospital without having given consent.

Battery involves intentionally bringing about a harmful or offensive contact with the person of another without consent. The civil action has a dual purpose of providing protection to the individual against bodily harm and also against any interference with his or her person which is offensive to a reasonable sense of dignity. For this tort to be committed it does not matter that the interference was only trivial and did not involve pain. There need be no intention to hurt the plaintiff, but only an intention to apply physical force of some kind.

Although the physical damage suffered by the plaintiff may have been trivial, the courts have the power to award exemplary damages to take account of the affront to the persons' dignity. Thus substantial awards are sometimes made for battery in medical cases.

In medical cases, examples of when battery may be committed include circumstances when the patient:

• Is treated against his or her will.
• Consents to one treatment but receives another or an additional treatment.
• Is given treatment without being told that this will happen.
• Is treated under duress.
• Agrees to treatment after being provided deliberately with information which is wrong.

An example might be the case of a woman who has consented to a mastectomy, and at the same time re-construction with a silicone gel implanted is performed without her consent to that procedure having been obtained before surgery.

The case of Williamson v East London & City Health Authority [1998] Lloyd's Law Reports Medical, illustrates that it is essential for the patient to be informed of the nature and extent of the proposed surgery. Here the court found that the Plaintiff consented to one form of treatment, but was given another more radical operation. The plaintiff was given silicone gel breast implants at the age of thirty in 1979 for cosmetic reasons. In 1982 she underwent a closed capsulotomy on her left breast, and three years later a similar procedure on her right breast. In 1988 under general anaesthetic she underwent closed capsulotomies on both breasts, but over the next three years she experienced further hardening of the right breast, and in June 1992 she consulted a plastic surgeon, a Mr. Kemble who was employed by the first defendants. He recommended a closed capsulotomy and warned of a small risk that the implant might rupture during this procedure. This was carried out in December 1992, and as a result silicone gel leaked from the right breast implant into the surrounding tissue. The plaintiff complained but no further investigation was carried out by Mr. Kemble.

In August 1993 the plaintiff consulted a Mrs. Neill, a plastic surgeon who was employed by the second defendants. She noted that the plaintiff's right breast was lumpy with marked capsular contraction, and expressed the opinion that the right implant might be leaking. A mammogram was performed, and arrangements were made for the plaintiff to have an open capsulotomy, for the lumps to be excised and for the implant to be replaced. The plaintiff signed a consent form for these procedures.

On April 26th 1994, after the plaintiff's condition had deteriorated further, she was examined by Mrs. Neill just before surgery, and lumps were discovered in her right armpit and down her right arm. Mrs. Neill stated in evidence that she had explained to the plaintiff at this point that a more serious operation would now be necessary, and that she would have to remove most of her right breast and possibly also the underlying muscle, though she could remember whether she had used the word "mastectomy". She said that it was her understanding that then plaintiff had understood very clearly what was involved and had accepted the changed situation.

The plaintiff denied that there had been any such explanation or that she had consented to more radical surgery. She did not countersign the original consent form, signed in January 1994, which had been altered to read "Bilateral replacement. Breast prosthesis. Right subcutaneous mastectomy. Excision biopsy. Gland axilla........"

The defendants produced evidence that when she excised the right breast there were multiple granulomas, that she had never seen a worse case, and that there was no option but to perform a mastectomy. The underlying muscle also needed to be removed. Later, a consultant pathologist diagnosed silicone granuloma.

The judge found that the plaintiff had not consented to such extensive surgery as had been performed, because on the balance of probabilities Mrs. Neill had not explained adequately her intention to perform a very different operation to that which had been considered appropriate originally. He found that the plaintiff was entitled to an award for of £20,000 for the injury suffered as a consequence of the "negligent" failure to acquire consent to the operation in question.

It is a little unfortunate that the judge used the word "negligent" in this context as the tort involved here was undoubtedly battery. It is assumed that the word was used to mean "reckless" or "careless", and that there was no suggestion that the tort of negligence (see below) applied. Battery is the appropriate action a different or more extensive medical procedure is carried out from that for which the plaintiff consented. Negligence is appropriate when the plaintiff is given the expected treatment but is not given appropriate information about the risks and side-effects attached to it.

2.2 Negligence
If the patient consents to a particular treatment but does so without having received appropriate information beforehand, the correct action is negligence.

In the leading case of Chatterton v Gerson [1981] QB 432, the position was explained by the judge in the following terms:

"It would be very much against the interests of justice if actions which are really based upon a failure by the doctor to perform his duty adequately to inform were pleaded in trespass".

"Once the patient is informed in broad terms of the nature of the procedure which is intended, and gives her consent, that consent is real, and the cause of action on which to base a claim for failure to go into risks and implications is negligence, not trespass. Of course, if information is withheld in bad faith, the consent would be vitiated by fraud".

2.2.1 The elements of negligence
It is more difficult to prove negligence than trespass to the person. In order to succeed in negligence the plaintiff must establish that:

• s/he was owed a legal duty of care by the defendant, and
• that the defendant was in breach of that duty, and
• that the breach of duty caused the damage of which s/he complains.

In actions concerning the issue of failure to provide adequate treatment information the focus is usually on one or more of the following points:

• the scope of the duty to disclose.
• breach of the duty to disclose.
• causation - whether the breach of the duty to disclose caused the damage.

2.2.2 Duty of care
In the context of consent to breast augmentation treatment it can be assumed that a duty of care is owed by the doctor to the particular patient. The crucial questions concern breach of duty and causation.

2.2.3 Breach of duty
In an action concerning consent to treatment, in order to establish breach of duty, the Plaintiff needs to prove that she had been given inadequate or inappropriate information before surgery about the procedures to be performed and the material risks attached to them and about the immediate and long-term effects of the surgery.

This turns on the important question of what information is "appropriate" in the circumstances. While in some jurisdictions the rule is that a person must be provided with full information on which to base a decision about treatment, in UK law the rule is that the appropriateness of the information is determined by the test laid down in the case of Bolam v Friern Hospital Management Committee [1957] 2 All ER 118, (the Bolam test). This is a peer-group test by which a doctor is judged not according to what the court considers would have been reasonable in the circumstances, but according to what a responsible body of medical opinion skilled in that particular field of medicine would have considered appropriate.

In the leading case on consent to medical treatment, Sidaway v Governors of Bethlem Royal Hospital [1985] 1 All 643, the House of Lords, confirming that the Bolam test applied, ruled that how much and what kinds of information a doctor should disclose in order to inform a patient before obtaining consent, is a matter of clinical judgment. Thus the information to be given to the patient before surgery is not a matter of meeting criteria which have been objectively determined, but a matter for the doctor to decide. Moreover, it is irrelevant that there is an alternative body of medical opinion which would have provided the patient with more information, as long as a body of opinion exists which supports what the defendant did. Ultimately this is a matter for expert evidence, but providing a doctor can demonstrate that a reasonably competent practitioner in a similar situation would not have mentioned a certain risk, he or she will escape liability.

There have been one or two cases in the UK (e.g. Smith v Tunbridge Wells Health Authority [1994] 5 Med LR) in which the Courts have taken a more pro-patient approach to the issue of information provision, but these have been decided only at High Court level and the Sidaway principle remains firmly entrenched in UK law.

The House of Lords has recently modified the Bolam test in the case of Bolitho v City and Hackney Health Authority (1997) 39 BMLR 1, in which it was decided that a judge may on certain rare occasions choose between two bodies of medical opinion, if one is to be regarded as "logically indefensible". However, for the time being this new approach does not extend to cases involving consent to treatment. Lord Browne Wilkinson specifically excluded consent cases when he said: "In cases of treatment and diagnosis there are cases where, despite a body of professional opinion sanctioning the defendant's conduct, the defendant can properly be held liable for negligence (I am not here considering questions of disclosure of risk)."

Since the Sidaway case, incorporating the Bolam test still applies to consent to silicone gel breast implant surgery the question of what risks are "material" and should be disclosed would depend upon medical opinion at the time the implant was inserted. In the light of today's knowledge, it would certainly be advisable to warn about the possibility of bleed of gel from the implant, of rupture, and of the need for replacement implants at some future date. Any information provided to a patient is only to be judged in the light of scientific knowledge available at the time the advice is given (Roe v Ministry of Health [1954] 2 QB 66, and section 4(1)(e) of the Consumer Protection Act 1987).

Non-therapeutic procedures
It has been suggested in some cases at High Court level that if a treatment is non-therapeutic there is a stronger case for requiring the doctor to disclose as much information as possible about the treatment, especially if the patient specifically asks about the risks involved, (Gold v Harringey [1987] 2 All ER 888). However, this has not yet been accepted in UK law, as the view was rejected by the Court of Appeal. In any event, it appears from the evidence presented to the Independent Review Group that the use of breast implants should be regarded as therapeutic treatment. The overwhelming opinion of the experts in the field and of women themselves is that successful augmentation and reconstruction of the breasts results in enormous benefits in terms of quality of life.

The need for guidelines identifying objective standards
The present trend towards evidence-based medicine and the use of guidelines to direct clinicians as to what is "best practice" affords the opportunity for identifying and applying objectives standards in medical practice. Ideally guidance should be given to General Practitioners and Surgeons as to what information should be provided to patients about silicone gel implants. This could be achieved by means of patient-information leaflets and the use of checklist during pre-operative consultation.

2.2.4 Causation
There are two aspects of causation:

1.    The plaintiff must show that it was at least 51% likely that if she had been given adequate information she would not have had the breast implant. The onus is not on the defendants to prove that she would not have refused. It is not clear from the UK cases whether a subjective or an objective test must be used to decide whether the plaintiff would have had the treatment if she had known of the risks, but is likely that the court would take into account the person's temperament and general characteristics when considering this point. The Commonwealth Courts support a subjective test, asking would this individual, rather than a notional reasonable person, have undergone the treatment had she known what was involved?

2.    If she is successful in establishing the first point, the plaintiff would also have to prove that on a balance of probabilities the implants caused or materially contributed to the illness of which she complains. This is a matter of scientific proof by examining the testimony of expert witnesses.

In America there have been claims involving silicone gel breast implants in which it has been possible to convince juries on this second causation point. However, since juries are not used in negligence claims in the UK the position is entirely different. It would be a good deal more difficult to convince a judge that the symptoms from which the plaintiff was suffering were caused by silicone implants and not by some other factor. If there are several possible causes of an illness it is for the plaintiff to prove that it was the defendant's breach of duty which was a material cause (at least 51%) of her illness. It is notoriously difficult to prove causation when there is more than one causal agent at work, especially when the aetiology of various illnesses is not fully understood by the medical experts who give evidence.

3. Actions in contract Law
As many breast implants are performed privately there is the possibility of action for breach of contract by a woman on the basis that she was not properly informed about the risks involved in the operation. However, the same basic principles would apply as in the action for negligence, and for the most part there is no particular advantage in suing in contract.

4. The wider context
4.1 Throughout the world the question of information provision before treatment has been treated differently, but the UK law tends to be very conservative in its approach, leaving the matter up to the clinical judgment of the doctor.

4.2 In Australia the case of Rogers v Whitaker [1992] 67 AWR 47, has established that where a patient requests detailed information about all risks, even those which a doctor would regard as remote, that information must be provided. In English law the rule still prevails that a patient who asks specific questions about a particular treatment is not automatically entitled to full answers to those questions, because the Bolam principle would again apply, (Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151).

4.3 In America there has been a doctrine of informed consent for some time. This doctrine requires that people about to undergo medical treatment be provided with all material information needed to make an informed decision, (Canterbury v Spence (1972) 464 F (2nd) 772). The determining factor as to what risks are material is that of the "prudent patient", rather than the doctor's assessment of what should be disclosed. There have been several well-publicised cases in America in which women have succeeded in claims against the manufacturers of silicone gel breast implants. The vast majority of these have not concerned the consent issue.

4.4 In Canada the doctrine of informed consent is well-established (Reibl v Hughes (1980 114DLR (3rd) 1 in general terms, and there has been consideration of the question directly in connection with silicone gel implants. The case of Hollis v Dow Corning ((1995) 129 D.L.R. (4th) 609) decided by the Supreme Court of Canada is of great importance for Canadian law. The plaintiff underwent breast implantation surgery when she was aged 23 years and was not warned by her surgeon of possible post-operative complications, including rupture. Her implants ruptured in 1985 and were removed later that year, but she continued to suffer from pain and breast lumps. She underwent a double mastectomy in 1987 and in 1989 she sued Dow for negligent manufacture of the implants, and alternatively for failing to give adequate warning of the risk of rupture.

An appeal by Dow Corning against a finding of liability because they had failed to provide adequate warning of the risk of rupture was dismissed. The Supreme Court ruled that consumers are entitled to full and up-to-date information about the risks which are attached to the ordinary use of any product, and that is a continuing duty. The manufacturer could, however, discharge that duty by ensuring that any intermediary, such as a surgeon, is fully appraised of the risks and is kept up to date about new information coming to light about the product. There had been a delay in communicating new information which had been discovered between 1983 and 1985, about the greater possibility of rupture and the extent of its consequences. The Supreme Court also decided that the correct test to apply when determining causation was a subjective test, and there was sufficient evidence here of the plaintiff's temperament to indicate that she would not have had the implants had she known of the risks. The Court held that it was not open to Dow for them to claim that even if they had passed on new information to Dr Birch, the surgeon in the case, he would not have communicated it to the plaintiff.

This Canadian case has only persuasive authority in the UK, but may be taken into account by UK courts considering what information should be provided to women before implant surgery. However, it must be remembered that Canadian law goes considerably further towards advancing patient autonomy, and in UK law there is at present no requirement that all possible risks, however small must be disclosed.

4.5 A potentially significant development lies the Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, which has been issued by the Council of Europe (European Treaty Series/164, 4,IV.1997). This Convention opened for signature in April 1997.

Article 5 of the Convention states:
"An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks, The person concerned may freely withdraw consent at any time".

The explanatory report issued with the Convention espouses the view that patients should be able to give free and informed consent to medical treatment, and states that the information provided to the patient should include relevant facts about the proposed treatment, the purpose, nature and consequences of the intervention, and the risks involved, including risks involved in alternative treatments and those related to the individual patient, such as age or the existence of other pathologies. The document advises that requests for additional information be adequately answered.

Member states will only be bound by the Convention if and when they ratify it, and the guidance appears to go beyond the consent requirements in the present UK law, but it is evidence of a general drive towards patient autonomy in the developed world.

5. Summary and advice
5.1 The main focus for concern is the issue of how much pre-operative information should be provided to breast implant patients about the usual course of progress after surgery and about any material risks connected with silicone gel breast implants.

At present there is no commitment to a doctrine of informed consent in UK law, and the general rule is that while a patient is entitled to receive information concerning the material risks associated with treatment, the amount of information which should be provided is determined by the Bolam test which still applies in this context. As long as a doctor is found to have acted in accordance with a responsible body of medical opinion there can be no finding of negligence. It is possible under the present legal regime for a doctor to escape liability for negligence if the patient considers that insufficient information about remote or uncertain risks, or risks about which medical opinion is divided, was given to her before surgery.

However, once a doctor provides information it is up to the patient to decide whether to accept the treatment. That decision will be valid even if it is irrational, and consent should be recorded in writing as a matter of routine, together with a signed statement by the patient to the effect that pre-consent counselling has been given. Any proposed variation in treatment should be countersigned by the patient.

5.2 The Patients' Perspective.
Despite the fact that UK law does not require full and detailed provision of information to patients before treatment, for the following reasons full information about the risks and benefits of silicone gel implants should be provided to patients before surgery:

5.2.1 There is a drive towards patient autonomy in many jurisdictions. This is reflected in the European Biomed Convention outlined above. In line with this trend and developments in other countries it would be wise to establish good practice in the UK by allowing women to make informed choices about surgery. As long as details about all known risks can be provided without causing alarm to women, so outweighing the benefits of breast augmentation, it would be wise to provide the fullest possible information about silicone gel implants, both orally and in the form of an information leaflet before surgery. Any new information coming to light at a later stage should also be provided if possible.

5.2.2 The medical profession in the UK is now moving towards requiring recognition of patient autonomy. For example, The Medical Defence Union advises its members that:

"Notwithstanding the legal principle, members should be aware that there is an increasing view among healthcare professionals, lawyers and the public that patients should be advised of all possible risks. The MDU continues to advise that it is all the more important that the nature, purpose and material risks of the procedure are explained to patients in non-technical language."

The GMC has stated its intention to issue new guidelines to doctors indicating that they have a duty to provide frank explanations to patients when treatment does not proceed as expected. This in effect amounts to a commitment by the medical profession to respect patient autonomy.

5.2.3 The Patients' Charter advises patients that they are entitled to full information about the treatment which they receive. This has raised patients' expectations generally about their entitlement to information.

5.2.4 With the emphasis on evidence-based medicine there is increasing use of guidelines which define good medical practice. These are frequently available to patients as well as to healthcare professionals. Technological developments and improved communications systems facilitate the dissemination of such guidelines, and there has never been a better opportunity to draft and disseminate authoritative guidelines on pre-operative advice which should be provided to patients.

5.2.5 The Review Group has received evidence that some women are placed under considerable sales pressure, especially at cosmetic clinics. It appears that frequently too little time is devoted to counselling of patients and that advice is inadequate as a basis for consent. The members of the Review Group also heard that some women do not even tell their families that they are intending to have breast augmentation surgery, and prefer not to seek referral through General Practitioners. This makes such women particularly vulnerable to high pressure sales techniques, and some are wrongly led to believe that minor surgery is involved and that it only takes a matter of a few weeks to recover from the operation.

It is essential that women have the opportunity to make informed decisions about their treatment to enable them to assess the risks and benefits of silicone gel breast implants in the light of realistic information which is factually accurate about the operation and about the implants themselves.

5.2.6 The media coverage of the perceived problems with silicone gel breast implants has provided an unreliable basis upon which women can make decisions. Information available on the Internet is not always reliable. Clarification of the scientific evidence of the risks and benefits in clear and unemotive lay language is required.

5.2.7 Since research suggests that many patients have poor recall of oral information, written information should also always be provided. Ideally this should be information should be uniform throughout the NHS and private healthcare. The information provided should be comprehensive.

Patients receiving implants should also receive a copy of the manufacturer's information leaflet which defines the product lifetime and gives other information about the type of implant to be used and compliance with the EC Directive on medical devices (93/42/EEC)

5.3 The Doctor's Perspective
The responsibility for providing patients with information rests with manufacturers, general practitioners and surgeons, but the ultimate responsibility for pre-operative counselling must be taken by surgeons. General practitioners should be aware that there is a possibility that an adverse reaction can occur in some women, and that even the normal recovery period after breast implant surgery can sometimes be long and difficult.

5.3.1 It is necessary to distinguish between what women can expect to be the "normal" outcome of surgery and the usual progress during the recovery period, and "material risks" associated with breast augmentation. What constitutes a "material risk" in this context is for medical experts to identify. The doctor should state the advantages of implant surgery in the light of these risks, and should counsel patients in that context. Patients should also be told that further surgery may well not be available on the NHS, and should be made aware of the possibility of further expenditure if the implants need to be removed or replaced.

5.3.2 In order to assist members of the medical profession, guidance for women containing details of the risks and benefits of silicone gel breast implants should be drafted and distributed to general practitioners and surgeons. The information contained in this guidance and a checklist of topics to be covered should assist all medical professionals who counsel patients before breast implant surgery. Details should be provided about the usual progress of patients post-operatively, of risks which may arise and of the long-term prospects. Even the unsubstantiated claims of anti-silicone groups should be stated, (with appropriate caveats), but the use of emotive terminology should always be avoided. If doctors follow well-drafted guidance which complies with good medical practice they are unlikely to be found negligent. Accordingly, there would be a reduction in litigation on the issue of consent to treatment.

5.3.3 By respecting autonomy and providing sound information which allows patients to make decisions in full knowledge of the risks and side-effects of proposed treatment, the prospect of litigation would be reduced. There is less likelihood of a dispute about what information was communicated to the patient if there are standard written information leaflets. A checklist containing an outline of the matters which need to be discussed should be attached to consent forms.