Cosmetic interventions under the knife – the impact of enhanced regulation

New guidance for cosmetic procedures

The General Medical Council (GMC) has published new guidance directed at all doctors who offer cosmetic procedures or "interventions" in the UK. A cosmetic intervention is any procedure or treatment carried out with the primary objective of changing an aspect of a patient’s physical appearance. The new guidance covers both surgical and non-surgical procedures, ranging from breast augmentation and cosmetic genital surgery to Botox. The guidance came into force in June 2016.

Background

After the manufacturer of PIP breast implants was found to have supplied devices filled with industrial rather than medical grade silicon – which affected 47,000 women in the UK – the Government commissioned The Keogh Review of the regulation of cosmetic interventions. The report "highlighted major problems with unsafe practices in the cosmetic sector, including poor follow-up care and record keeping, and misleading and inappropriate advertising and marketing techniques," and recommended that the GMC develop new guidance for the ethical conduct of cosmetic surgery.

The demand for cosmetic surgery has grown rapidly in recent years and is no longer a niche area of medical practice but a widely available service. Inevitably, of course, a greater number of procedures means a greater potential for things to go wrong and the new GMC guidance aims to ensure a high standard of care among all cosmetic surgeons.

The Review

The GMC set up the Task and Finish Group (TFG) to conduct this work. Its membership comprised doctors with expertise in both surgical and non-surgical cosmetic interventions, a nurse and lay members. The TFG undertook a consultation process on its draft of the new guidance, and after analysis of the responses alterations were made to the guidance. The final draft was approved by the GMC in February 2016.

Professor Terence Stephenson, chair of the GMC, said: "it is a challenging area of medicine which deals with patients who can be extremely vulnerable.... Our new guidance is designed to help drive up standards in the cosmetic industry and make sure all patients, and especially those who are most vulnerable, are given the care, treatment and support they need."

The recent Regulation of Cosmetic Interventions Report shows an increasing demand for cosmetic surgery amongst teenagers and young adults and people with certain mental health conditions such as body dysmorphia who are vulnerable to being sold multiple procedures and undergoing unnecessary surgeries to correct perceived imperfections – meaning tighter monitoring is even more important.

What practitioners must do

In order to meet the requirement of the updated guidance from the GMC, there are a number of key areas in which practitioners must ensure they reach a higher standard of care. These increased standards can be identified in four main areas:

Knowledge, skills and performance

Consultants undertaking cosmetic interventions must recognise the extent of their competencies. Where a procedure is outside of the limits of a consultant’s own expertise a patient must be referred to a professional colleague who can safely meet their needs.

If carrying out a procedure for the first time, a practitioner must carry out the intervention safely. This could include receiving training on the procedure or by carrying it out under supervision. In this regard, consultants must ensure they constantly maintain and increase their competence in the areas in which they practice. This will include ensuring they are up to date with the law, clinical and ethical guidelines where they are applicable and follow them.

Consultants must ensure that they both solicit and act on feedback from patients in order to improve the quality of their work. This should include views on both the physical and the psychological outcomes of the procedures undertaken. Consultants must also ensure that their annual appraisal is comprehensive and encompasses the full extent of their practice.

Safety and quality

Practitioners in this field must ensure that they follow the general guidance of the GMC (as set out in good medical practice) to maintain high standards of safety for patients. In this regard, deploying systems which improve service delivery and ensure high quality practice is of high importance. They must comply with statutory regulations involving reporting duties and contribute to systems for monitoring the quality of practice nationally as well as any device registries where relevant.

The regular monitoring of outcomes for patients and reporting on at least an annual basis is imperative, as is reporting any product concerns to the relevant regulatory bodies.

Important information about cosmetic interventions which is relevant to other practitioners in the field should be shared with the aim of improving safety for patients. In this regard, patients must be informed of the ways in which complications and adverse reactions to procedures should be reported. Practitioners must seek to act on information about improving safety received from other professional colleagues so that their practice is always based on the latest evidence about the risks and other issues involved.

Practitioners must ensure that the environment within which they practice is safe and complies with any relevant regulations. If a patient suffers or could suffer harm or distress as a result of a complication during a procedure practitioners must be open and honest with them or those close to them.

Communication, partnership and teamwork

Pre-operatively

Practitioners must communicate effectively with their patients, considering whether they require any support in the decision process and listening to their concerns. It is essential that practitioners seek the consent of their patients themselves to the procedures to be undertaken and do not delegate this responsibility. This is to ensure that there is a mutual understanding of both the expectations and the limitations of any cosmetic intervention.

Practitioners must consider the medical history of any patient seeking a cosmetic intervention and, based on this, assess the appropriateness of the procedure for the patient and whether the outcomes are likely to be satisfactory for them.

If it is the practitioner’s belief that the intervention is unsuitable for the patient and not in their best interests, they must discuss these concerns with the patient. If the practitioner is still of the belief that the intervention will not be beneficial for the patient they must not provide it but instead discuss other available options and explain the right the patient has to seek a second opinion.

It is also imperative that a practitioner considers the vulnerabilities and needs particular to the patient, and must be satisfied that the request for the intervention is a voluntary act of the patient concerned.

Any follow-up care or monitoring must be explained at the outset of the intervention including the need for the replacement or removal of medical devices used in a procedure and a timeline for these needs.

Patients must always be told about alternative interventions that present fewer risks and are available, including those provided by other professional colleagues.

Patients must be informed of any side effects that could result from any cosmetic intervention and any related procedures (such as anaesthesia) in accordance with the GMC’s general guidance on consent. There must be clear and accurate information provided about the potential impact of the intervention being ultimately unsatisfactory to the patient or something going wrong.

Patients should always be given sufficient time and information to consider the intervention so that they reach a considered decision about whether the procedure should be undertaken. Practitioners must be aware that the amount of time and information required will vary with the nature of the intervention in question and the alternatives available to them. Patients must be aware that they can change their mind at any stage.

Complex consent issues

If the patient involved is an adult who lacks capacity then the GMC’s general guidance on consent in such circumstances should be followed in order to ensure compliance with legal requirements for such situations. The clinician must also consider the views of those close to the patient as well as any information available to them about the patient’s wishes and values.

If the intervention sought is for a child, then the GMC’s guidance for the treatment of those under 18 years of age should be consulted. Special care should be taken to ensure that the environment is suitable for the treatment of children and, where necessary, care should be delivered in conjunction with practitioners with expertise in paediatric care. Interventions must only be provided where it is in the best interests of the child. Even where the child has capacity, the involvement of their parents should be encouraged. Where the child does not have capacity, the decision can be made on their behalf by a parent, but care should be taken to involve the child as much as possible in the decision process. If the consultant believes that the child does not want the procedure to be undertaken, it should not be performed. Children and young people must not be the target of any marketing activities concerned with cosmetic interventions.

Involvement of GP

Always consider whether it is necessary to consult the patient’s GP regarding the request for a cosmetic intervention, and, if so, seek the patient’s permission. Should they refuse, clinicians should encourage the patient to let them do so. If this request is still refused then this should be recorded and borne in mind in considering whether the intervention is beneficial for the patient and should be performed.

Delegation and funding

If any care is delegated to another medical professional, then ensure that they have all the necessary knowledge, training, skills and supervision required to provide it. Practitioners must work effectively with other professionals providing care, and support colleagues to deliver safe and high quality treatment to patients. If a patient has a health condition which is outside of the expertise of the practitioner, then advice must be sought from professional colleagues who are knowledgeable in the relevant field. Practitioners must endeavour to build a network of professional colleagues to provide advice and support in circumstances such as these.

Clinicians must explain in full and in clear terms the financial implications of an intervention, including the costs of any follow-up or monitoring treatment that will be required after the procedure has taken place. They should make sure that all patients understand the need for follow-up treatment where necessary, and ensure that any medicines or equipment required for self-care are provided to the patient. The patient must be made aware of how to contact either the consultant performing the procedure or another qualified professional if they require medical assistance.

In conjunction with this requirement, patients should be given sufficient information about the procedures undertaken to allow another medical professional to take over their care, including information regarding the medicines and devices used. If the patient consents, this information should also be sent to their GP. If this consent is not given then this should be recorded in their medical notes, and the consultant will remain responsible for their follow-up care.

Such medical records should be organised in a fashion that allows for the identification of patients treated with a particular medicine or device should regulatory or product safety concerns arise at a later date. All records should be kept securely and in line with data protection requirements, the GMC’s guidance on confidentiality, and the guidance published by the UK health departments (even where the treatment is provided outside of the National Health Service).

Maintaining trust

It is also essential that consultants consider whether it would be appropriate to refer the patient to another professional colleague, in recognition of the limits of their own competence. Clinicians have a responsibility to seek advice where necessary in this regard, and to be open and honest about their capabilities.

Practitioners have a responsibility to market their services responsibly without using promotional tactics that might encourage patients not to consider fully the procedure to be undertaken. The risks involved in interventions must not be trivialised and the claims made about the beneficial impact of procedures must be justifiable. Procedures must not be offered as a prize and practitioners must not allow others to misrepresent or offer their services in a manner which would contravene this guidance.

Practitioners must be open about any potential interest that could impact on their advice to patients regarding the interventions they provide. Furthermore, they must not allow any financial interests to impact on either advice given to patients concerning cosmetic interventions or to the standard of care provided to them.

Good medical practice

As medical professionals, clinicians must also comply with the general guidance given by the GMC which advises that all doctors must treat patients with dignity and respect. The safety of patients is paramount, which must be an active concern of professionals who must report any concerns they have in this regard.

They must keep up to date with and abide by the relevant law and guidance in their field, work effectively with colleagues, and be transparent with regard to their professional skills, experience, fees and any conflicts of interest.

Conclusion

It is tempting to see new guidance as merely red tape or reinventing the wheel. In fact, the latest stipulations represent carefully thought out responses to crises within the cosmetic surgery industry and reflect the problems which have led to record numbers of claims within this sphere. By taking the time to read these rules and adhere to them, practitioners will understand their patients better and ultimately improve patient experience and increase patient safety. In turn, this will make practitioners even better at their jobs and protect them from avoidable litigation. From a broker’s or underwriter’s perspective, it would be sensible to send copies of the guidelines out to clients and offer discussions and training around the topic.