Regulation in Aesthetic Medicine- past and future

 

Introduction

Aesthetic medicine is a term used by medical professionals to describe surgical procedures and medical treatments that aim to improve a person’s appearance or subjective well-being.[1]

Public appetite, celebrity endorsement and media fascination have helped cosmetic procedures, worth approximately £2.3 billion in 2010 in the UK, grow towards an estimated £3.6 billion by 2015. Social media and the internet take credit for the changing attitudes and resultant market growth. 

In the UK 6.5% of women had had cosmetic surgery and 45% wanted it.[2]

The Girls Attitudes Survey discovered that 25% were unhappy with their looks and 90% would change some aspect of their appearance.[3]

In 2013, 75% of all cosmetic procedures performed were non-surgical[4]. Subsequent estimates predicted this figure would rise to 90% by 2015.[1]

Health tourism has been an issue for some years, with 75000 UK citizens traveling abroad for cosmetic surgery in 2008.[5] Recently concerns have been raised that different regulatory standards within the UK may result in cross-border tourism for non-surgical cosmetic interventions (NSCI’s).[6]

 

Background

The PIP scandal has been credited with the change in public awareness to the risks of cosmetic treatments, this awareness accentuated by the lack of government regulation and inadequate self-regulation. In the immediate aftermath, UK patients were affected by a lack of insurance for removal/replacement, a lack of fully qualified surgeons to provide further surgery, and a lack of implant registry to inform or reassure women whether they had PIP implants.

More generally there were concerns regarding advertising, selling techniques, operative facilities and consenting procedures.

The non-surgical procedures were also highlighted as being in need of regulation, being subject to fewer restrictions than cosmetic surgery. Some of these treatments are delivered by nonregulated practitioners including beauty therapists.

The Medical Devices Agency, part of the Medicines and Healthcare Products Regulatory Agency (MHRA), is the Competent Authority in the UK for overseeing conformity of medical devices to European safety standards. It puts the onus mainly on manufacturers to ensure devices safety. Medical devices are awarded a CE mark of conformity by one of 80 independent european ‘notified bodies’ so they can be marketed and sold across the EU.

The MHRA first noted concerns about the PIP implant in 2008, 2 years after publicly reported concerns by surgeons. The Howe report exonerated the MHRA, saying they adequately dealt with concerns, reporting them to the inspection agency who eventually unearthed the scandal.[7]

What is noteworthy however is that the MHRA didn’t warn providers or the public until December 2011.

This compares poorly with French women who were immediately informed and advised to consult their surgeon, then later to have stringent surveillance, with implant removal if there was any suspicion of rupture.

In 2012, the french health minister planned an inquiry into failings of the EU licensing and inspection systems. Some would argue that while the French considered it a ‘scandale’, in the UK it was treated more like a scare.[8]

During the review process leading up to the Keogh report, stakeholders from all groups held the view that a new legislative framework was required to effect quality regulation.

Those having cosmetic procedures are often vulnerable and yet assume their provider has had specialist training, has appropriate insurance and provides aftercare.

The Keogh review [4] had key recommendations:-

High quality care

• New legislation should classify fillers as a prescription-only medical device

• The Royal College of Surgeons should establish a Cosmetic Surgery Interspecialty Committee (CSIC), its purpose to set standards for surgical practice and arrange formal certification of cosmetic surgeons

• Registration for all those performing cosmetic interventions

• HEE should develop accredited qualifications which should be tiered depending on the professional group and treatments concerned

• Re-establishment of a breast implant registry

An informed and empowered public

• The operating surgeon should take fully informed consent before the operation.

• The importance of development of evidence-based standardized patient information.

• Providers of NSCI’s should hold a record of consent.

• Prohibition of time-limited offers or financial inducements.

Accessible resolution and redress

1. The remit of the Parliamentary and Health Service Ombudsman (PSHO) should extend to cover the private healthcare sector.

2. Individuals performing cosmetic interventions must have appropriate professional indemnity insurance

 

Regulation

Regulation has become an instrument to solve a problem of a community seen to be, or which perceives itself to be at risk.

Effective regulation needs to manage actuarial, sociocultural and political risk. Actuarial risk management by regulation is evidence-led and quantitative, being more likely to avert future risk by ensuring appropriate, proportionate ongoing reform and compliance. Sociocultural risk management reassures a public that feels vulnerable, while political risk management prioritizes political legitimacy for future government success.[8]

The cosmetic surgery sector has already seen regulation take place as part of wider reforms, particularly the Care Standards Act 2000 which was enacted to better regulate private practitioners of aesthetic medicine[8]. Under the act, practitioners were required to either be on the specialist register or have undertaken relevant specialist training if they were practicing before 1 April 2002.

The act also stipulated that patients should be interviewed pre-operatively by the consultant and be given a pre-treatment cooling off period of 2 weeks before treatment.

The Health and Social Care Act 2008 emphasized the importance of consent, aftercare, sanitation and training. Individuals and employers providing surgical treatments, being already regulated by the Care Quality Commission (CQC), led to suggestions that this organization playing an inadequate role. Of note, the CQC doesn’t regulate non-surgical procedures.

France has already enacted legislative change, having reacted to healthcare scandals in the 1990s involving contaminated products. The Kouchner law (2002) devoted a chapter of the law to cosmetic surgery.

It has been argued [8], that the older Kouchner law was a much more thorough piece of legislation than the Keogh report and had already dealt with surgeon insurance, qualification and audit.

The french had also already addressed advertising, sales, consent, sanitation and to some extent, cosmetic medicine.

Before the PIP scandal, successive UK governments chose to ignore requests for stricter regulation of cosmetic surgery.[9] Private establishments were left to monitor surgical standards.

Before the introduction of medical revalidation (2012), doctors deemed themselves competent in a procedure. Although not perfect, medical revalidation provides an opportunity to strengthen cosmetic practice. A ‘Responsible Officer’ assesses a doctor’s competence and fitness to perform their current role, thereafter making revalidation recommendations to the General Medical Council(GMC)[4]. Nurses and dentists are introducing similar systems.

There are no current standards or accredited training for NSCI’s. Anyone may legally perform these procedures without qualifications.

Regulation should ideally begin by identify general training requirements. These then used to identify, for each professional group, which needs haven’t been addressed by prior training.

The following are considered essential points:-

• Training must ensure that practitioners can identify and manage complications of treatment.

• NSCI’s must be performed under the responsibility of an accredited professional.

• Anyone prescribing fillers or performing potentially harmful non-surgical cosmetic procedure should be professionally accountable.

• Practitioners must be centrally registered, with registration being subject to accredited qualifications, premises requirements, adherence to a code of practice and regular, annual appraisal.

Previous attempts to encourage cosmetic injectable providers to self-regulate were made following the Department of Health’s 2005 Cayton Review. “Treatments You Can Trust” held little interest for the providers.

Ultimately the UK government are seeking:-

• Safety

• A system that pays for itself / takes care of itself

• Reduced burden on the NHS (An increasing cost)

• Formal mechanisms for reporting complications

Regulation ensures political legitimacy and as such the regulatory endpoint must be robust against future scandal.

 

The Current Situation

Currently the Care Quality Commission (CQC) regulate independent clinics offering cosmetic surgery and laser lipolysis in England. NSCI’s are otherwise unregulated.

There is no formal regulation of independent clinics in Scotland. Health Improvement Scotland (HIS) has legal powers that relate to independent health care services through amendments to the National Health Services (Scotland) Act 1978 by the Public Services Reform (Scotland) Act 2010. These powers have not been commenced, and notably if they were, they would exclude independent nurse led clinics due to a requirement for the presence of a medical or dental practitioner[6].

The Scottish Cosmetic Interventions Expert Group (SCIEG) was set up in January 2014 to consider the requirement for regulation of cosmetic procedures following the publication of the Keogh Review. Their deliberations led to a desire for a ‘risk-based’ approach introduced in three phases. This will start with registration and inspection of health-care professionals.

Health Education England (HEE) exists to improve quality of care delivered. Mandated by the Department of Health (DH) to conduct a review of qualifications required for delivery of NSCI’s [10], attention was focused on the five main areas identified in the Keogh Report:-

• botulinum toxin injections

• dermal filler injections

• chemical peels and skin rejuvenation treatments

• laser, intended pulsed light (IPL) and light emitting diode (LED) treatments

• hair restoration surgery

They have presented draft education and training frameworks, providing indicative content, the consistent aim being to provide opportunity for all practitioners to attain necessary skills. HEE’s remit covers delivery of non-surgical, level 2 interventions.

Cosmetic surgeons don’t require specialist qualifications in plastic surgery, rather training in ear nose and throat surgery, eye surgery and plastic surgery includes aspects of cosmetic training.

The CSIC was created, it’s remit to cover invasive surgical procedures. This includes level 1a procedures potentially involving general anesthesia as well as level 1b, lower risk procedures.

 

The Future

Changes are imminent. The government has the appetite and, given the market growth, the public needs protection.

Surprisingly the DH doesn’t agree to statutory regulation of all cosmetic practitioners, rather “will look to strengthen standards through training and qualifications and how far supervision from regulated professionals can support self-regulation of the sector”.[11]

Meanwhile we await the Phase 2 report from HEE regarding recommendations for accredited qualifications and course delivery.

In Scotland, changes to regulation begin soon:-

Phase one- Beginning in 2016 involving the commencement of existing powers to allow inspection of independent clinics provided by regulated health-care professionals. Statutory arrangements for independent clinics and the capacity for Healthcare Improvement Scotland to receive complaints from the public will foster improvement in the delivery of high quality care.

This will also help align regulation in Scotland with that already in existence in England.

Phase two- Will focus on cosmetic practitioners without membership of a statutory register. While details have not been finalised, SCIEG are hopeful that a combination of UK-wide policy and compulsory local authority licensing will provide the best option.

Phase three- to consider options for additional health professional. e.g. Clinical scientists supervising or performing aesthetic laser procedures.

As already noted, a major concern is the lack of regulation of dermal fillers. Only some cosmetic surgery implants fall under medical device regulations. e.g. Breast implants do, while buttock implants and dermal fillers do not.

The European Commission Proposal 14493/12 of 2015 recommends that products with aesthetic or other non-medical purposes such as body implants and fillers should be regulated within medical devices legislation. Time will tell how the proposals and those of the review committee will be implemented in the UK.[12]

Interesting too the growing trend for “request for treatment” using Patient-centred Consent Forms. Demonstrating capacity and consent, requesting treatment while acknowledging risks and complications, all by the patient’s hand certainly puts the patient at the centre of their care.[13]

Melanie Latham, from a middle-of-the-road feminist perspective regarding regulation, opined-

“the type of autonomy I want to promote as a principle of regulation then is one that entails fully informed consent; constructive dialogue and counselling that builds self-trust and recognise structural oppression; professional self-awareness and ideally an institutional commitment to work against damaging social and cultural pressures”[9].

I believe this applies to both sexes.

Ultimately, while a plethora of guidance is available, guidance is not regulation.

 

Bibliography

1. Tan KBH. Aesthetic medicine: a health regulator's perspective. Clinical Governance: An International Journal. 2007;12(1):13-25. Available from: http://dx.doi.org/10.1108/14777270710725364 [Accessed 15/11/15].

2. Molina AR, Baker RH, Nduka C. ‘What women want’—the UK's largest cosmetic surgery survey. European Journal of Plastic Surgery. 2012;35(8):607-612. Available form: http://link.springer.com/article/10.1007/s00238-011-0635-5#/page-1 [Accessed 16/11/15].

3. Girlguiding UK. Girls Attitudes Explored- Role Models. Available from: https://www.girlguiding.org.uk/pdf/GirlsAttitudesExploredRoleModels_FINAL.pdf [Accessed 16/11/15].

4. Department of Health. Review of the Regulation of Cosmetic Interventions. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/192028/Review_of_the_Regulation_of_Cosmetic_Interventions.pdf [Accessed 12/12/15].

5. Treatment Abroad. A world of medical opportunity:special report on health tourism. Available from: http://www.treatmentabroad.com/medical-tourism/a-world-of-medical-opportunity [Accessed 14/12/15].

6. Scottish Cosmetic Interventions Expert Group Report July 2015. Options for regulation. Available from: http://www.gov.scot/Publications/2015/07/2616/8 [accessed 3/12/15].

7. Howe FRPC. Review of the actions of the Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health. Department of Health. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216537/dh_134043.pdf [Accessed 18/12/15].

8. Latham M. ’If it ain’t broke, don’t fix it?’: Scandals, ‘Risk’, and cosmetic surgery regulation in the UK and France. Med Law Rev. 2014;22(3):384-408. Available from: doi:10.1093/medlaw/fwt033. Epub 2014 Jan 9. [Accessed 16/11/15].

9. Latham M. The shape of things to come: feminism, regulation and cosmetic surgery. Med Law Rev. 2008;16(3):437-57. Available from: doi: 10.1093/medlaw/fwn019. Epub 2008 Jul 18. [Accessed 10/12/15].

10. Health education England. Review of qualifications required for delivery of non-surgical cosmetic interventions. Available from: http://www.bdng.org.uk/news/Nonsurgical_cosmetic_interventions_-_Report_on_Phase_1_-_final_(2).pdf [Accessed 17/12/15].

11. Department of Health. Government Response to the Review of the Regulation of Cosmetic Interventions. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/279431/ [Accessed 16/12/15].

12. Council of the European Union. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. Available from: http://www.consilium.europa.eu/en/press/press-releases/2015/09/pdf/st12040-re01_en15_pdf/ [Accessed 1/12/15].

13. Shokrollahi K. Request for treatment: the evolution of consent. Ann R Coll Surg Engl. 2010;92(2):93-100. Available from: doi: 10.1308/003588410X12628812458851 [Accessed 10/12/15].