Introduction

Earlier this month it was announced that Sir Bruce Keogh, the NHS medical director, will lead a review into the cosmetic surgery industry. The review comes at the request of former Health Secretary, Andrew Lansley, following the industry’s recent adverse press coverage. Keogh previously led the review into PIP breast implants which, in June 2012, revealed that the implants did not cause any long term health threats, but nevertheless raised some serious questions about the industry and its regulation.

It has emerged that the Government is concerned both about regulation and the way patients view cosmetic surgery. It appears that when individuals choose to have cosmetic surgery, cost is a greater concern than safety. A recent survey of 1,762 people, conducted by ComRes, indicated that only just over half of those surveyed would take a practitioner’s qualifications into consideration when considering plastic surgery, whereas two thirds were concerned about the cost. Keogh has said: “I am concerned that too many people do not realise how serious cosmetic surgery is and do not consider the lifelong implications that it can have”.

The review

The review panel consists of 8 members and includes a plastic surgeon, a clinical psychologist, the former medical director of Bupa (Andrew Vallance-Owen) and the editor of Marie Claire magazine (Trish Halpin). As part of the process the panel have issued a call for evidence both to members of the industry and the public. This has asked for people’s views on:

  • the regulation and safety of products used in cosmetic interventions;
  • how best to ensure that the people who carry out procedures have the necessary skills and qualifications;
  • how to ensure that organisations have the systems in place to look after their patients both during their treatment and afterwards;
  • how to ensure that people considering cosmetic surgery and procedures are given the
  • information, advice and time for reflection to make an informed choice;
  • what improvements are needed in dealing with complaints.

These views will be collated and analysed and will be included in the panel’s recommendations, which are due to be reported to the Government in March 2013. The review will also look at whether clinics’ marketing is too aggressive and whether this should be more tightly controlled.

The review has specifically been asked to consider an implant register, so that those who have received cosmetic implants can be easily identified and the details of their procedures located.

The medical profession’s reaction to the review

One Edinburgh based surgeon has summed up the view of many and highlighted the need for a tightening of the law in this area.

“There is a lack of regulation and a Wild West approach out there. Any qualified doctor, under the current legislation, can pick up a scalpel. There’s nothing to stop someone with no surgical experience or training to do surgical procedures. Equally, there’s nothing to stop nurses injecting products which they have no experience or knowledge of.”

This concern is shared by the Royal College of Surgeons and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) and the British, Association of Aesthetic surgeons (BAAPS) who have all welcomed the review and indicated that they will co-operate. However, BAPRAS have warned that the review’s remit is huge and that they believe it will be difficult to satisfy and reassure the public that things will change, unless a huge amount of legislation is implemented as a result.

BAAPS asserted in a statement:

“We would like the review to take this opportunity to draw a clear line between cosmetic treatments that are seen as a commodity and cosmetic surgery that is a serious medical treatment which must be provided by fully trained and qualified surgeons. We also welcome the establishment of a compulsory independent national register for breast implants and other implantable materials including those that are given through injections.”

Commentary

Given the amount of press attention it has received, it seems highly likely that the review will lead to an increase in regulation.

Currently much of the litigation arising from cosmetic surgery concerns pre-operative advice, rather than the performance of the surgery itself. An increase in regulation may give patients additional grounds on which to bring claims in cases where they feel dissatisfied with the service provided. This could lead to an increase in the number of claims brought against providers of cosmetic procedures. It is vital that providers, their insurers and defence organisations are fully up to date and familiar with any changes to legislation. We shall look at some of these possible changes and discuss the likely effects.

Improvements to the consent process and the information provided to patients prior to treatment

As mentioned above, failings during the consenting process are currently the primary cause of claims within the industry. As with any medical procedure, it is vital that patients are advised fully and openly of the risks and benefits of all the various options. It is already established that advising fully as to one option, but failing to refer to other available alternatives may result in a finding that informed consent was not obtained. The provision of written information is advisable, but is not a substitute for a face to face meeting.

It is also envisaged that the new regulation will include a requirement to complete psychological screening on vulnerable patients.

A codification of the consenting process may bring clarity to the standards required and any breaches of those standards may then become more apparent. Nevertheless, it will remain the case that, in order to succeed in a claim for compensation, a claimant would have to establish both that the pre-operative advice was negligent and that they have suffered injury as a result of that advice.

Minimum training requirements for surgeons

This will mean clinics will need to ensure that their practitioners are suitably qualified and keep up to date with their training. This should reduce the risk of claims. It may change the wording of professional indemnity policies. Insurers will want to ensure these include warranties that require clinics to have controls in place to ensure that the required training standards are met.

Requiring clinics to have a built in “cooling off” period before patients undergo procedures

A requirement of this nature would work in tandem with the improvements to the consenting process and clinics will need to redraft their pre-operative information to ensure this period is catered for. A failure to comply with this “cooling off” period would lead to an obvious basis for a claim.

Regulations strengthening complaints systems

Such regulations are likely to control the information that patients must be given before they sign up for treatment and the procedures to be followed if patients are dissatisfied with the results. This will mean clinics and patients will need to follow formal complaints procedures before claims are issued. As a result, insurers may wish to inspect and/or include warranties regarding providers’ complaints procedures before agreeing to grant cover.

Forcing the industry to adopt a national “travel agency style” insurance model that every company would pay into and that would fund any remedial surgery necessary

In order to assess the likely effect of this change, we need to have more detail about the proposal. If bought in it is likely, in the short-term, to increase the costs of companies operating in the industry.

Tightening the rules on anti-ageing dermal fillers

Currently these can be administered by anyone and often are implanted at beauty salons. Stricter regulation should mean that the underwriting risk of insuring beauty salons will decrease as they will no longer be permitted to undertake such procedures.

It is not yet clear what form the new legislation or regulations will take. However, it will be vital that come March 2013, all those with an interest in the cosmetic surgery industry play close attention to the panel’s recommendations.