Keogh review of the regulation of cosmetic interventions published

The cosmetic interventions sector is widely unregulated and rapidly growing.  Claims arising out of procedures going wrong – from non-surgical "high street" treatments to invasive surgical procedures – are on the increase.  Today sees the long awaited publication of the Department of Health review, led by Professor Sir Bruce Keogh, of the regulation of cosmetic interventions.

The "normalising" of cosmetic procedures

Those seeking cosmetic treatments often look to them as a way to "feel better" about themselves.  They are frequently vulnerable people at risk of exploitation from an unregulated industry, inexperienced practitioners whose focus is on profit, unscrupulous advertising and pushy sales tactics.  The report identifies that a wide range of social, economic and technological factors have driven demands for these procedures, which has resulted in cosmetic interventions becoming ‘normalised’.  

People now openly admit to having procedures, and even see them as something to celebrate or aspire to.  Treatments are becoming quicker and less invasive (the majority of recent market growth being seen in the non-surgical interventions sector) and something which can be undertaken with little forethought or research and with the assumption that if somewhere is offering a service they must be ‘ok’.  

The reality can be very different; the majority of cosmetic interventions can be performed anywhere, by anyone.  Providers all too frequently have inadequate or no liability insurance and fail to offer any sort of care or support if things do go wrong.  Someone having a non-surgical procedure ‘has no more protection and redress than someone buying a ballpoint pen.’  The repercussions of things going wrong can be profound, and result in permanent scarring or disfigurement and psychological injury.

The recommendations set out within the Report aim to ensure that changes can actually occur, setting out a new legislative framework proportionate to the potential risks of cosmetic interventions.  No fewer than 40 recommendations have been made by the Committee, some of key of which are summarised below.

High quality care

• Establishment of a Cosmetic Surgery Interspeciality Committee to ensure standards are developed and consistently and appropriately applied across all areas of cosmetic surgical practice.  This should work with various other bodies (such as the Parliamentary and Health Service Ombudsman and the General Medical Council) on dispute resolution, and develop a specific code of ethical practice for cosmetic surgery, to include guidance on advertising, insurance requirements and the psychological assessment for patients.
   
• All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures.  Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional.  
   
• Accredited qualifications for providers of non-surgical interventions should be developed.  
   
• All practitioners must be registered centrally.   
   
• Those training to be non-surgical practitioners should have a clear understanding of the requirement to operate from safe premises, and the responsibilities involved.

Ensuring safe products

• The scope of the EU Medical Devices Directive should be extended to cover all cosmetic implants, including all dermal fillers.  UK legislation should be introduced to make fillers a prescription only medical device.
   
• Manufacturers should inform the Medicines and Healthcare Products Regulatory Agency (MHRA) when bringing a new product to the UK market and the MHRA should publish a list of the cosmetic devices available in the UK.
   
• The MHRA should develop a system to enable assessment of implant performance and the tracking and tracing of patients in case of a safety alert.
   
• A framework should be developed to encourage and support the reporting of suspected device failure to the MHRA.

An informed and empowered public

• People should be managed as patients and not consumers when marketing to them, considering their suitability and when undertaking consent.
   
• Evidence-based standardised patient information should be developed.
   
• Patient Decisions Aids should be developed for cosmetic procedures; these should be piloted by the RCS Interspeciaility Committee on Cosmetic Surgery.
   
• The RCS Interspeciaility Committee on Cosmetic Surgery should develop and describe a multi-stage consent process for operations.  This should be undertaken by the operating surgeon and its use should be mandated as part of the Code of Practice.
   
• For non-surgical procedures, a record of consent must be held by the provider.

Responsible advertising and marketing

Development of a code of ethical practice for all practitioners of cosmetic interventions, including standards to ensure that any advertising is conducted in a socially responsible manner.

The Committee of Advertising Practice should extend its guidance note on cosmetic surgery advertising to cover non-surgical cosmetic procedures and the sponsoring of TV and other programmes.

Socially irresponsible advertising practices such as time-limited deals, financial inducements, package deals (e.g. "buy one get one free") and offering cosmetic procedures as competitions prizes should be prohibited.

Accessible resolution and redress

All individuals performing cosmetic procedures must possess adequate professional indemnity cover that is commensurate with the type of the operations being performed.

Patients’ rights should be protected even when a provider goes out of business.  In particular:

• Providers must enter a risk pool or have appropriate insurance/financial arrangements to provide treatment following certain complications.
   
• The NHS should be able to recoup costs for management of certain complications following cosmetic procedures if the provider has been found to have failed the patient following surgery.

The insurance of all practitioners should be displayed on the practitioner register.  

Overseas surgeons operating in the UK should have the same level of professional indemnity as UK-based surgeons.

Providers and practitioners should provide continuity of care.  Patients should be offered appropriate follow-up and after-care, rather than stand-alone procedures.

The government responds?

Health Minister Dr Dan Poulter has issued a statement confirming what many of us dealing with claims arising out of the cosmetic industries have known for some time – it is time for the government to step in. 

"There is a significant risk of people falling into the hands of cowboy firms or individuals whose only aim is to make a quick profit.  These people simply don't care about the welfare of the people they are taking money from… It is clear that it is time for the Government to step in to ensure the public are properly protected."

Dr Poulter has indicated that the government will respond to the report in detail in the summer.  In light of this report, and the somewhat shocking research which supports it, coupled with extensive work from the Royal College of Surgeons and IHAS over the past years, surely the time has now come for a proper legislative framework which does put the safety and wellbeing of patients first, grants them protection against things needlessly going wrong, and gives them redress when it does.