Scottish Cosmetic Interventions Expert Group Report July 2015

5. Summary of evidence gathered

a) Literature review

To inform the deliberations of the SCIEG's HQC subgroup, and in turn the SCIEG, a rapid literature review was conducted (methodology in Annex 3). In keeping with the broader SCIEG work, the following five categories of procedures were focused upon: botulinum toxins; dermal fillers; lasers, IPL and LED; chemical peels and skin rejuvenation; and hair restoration surgery.

The academic literature was searched to answer the following questions:

• What is the reported frequency of uptake of different procedures?
• What are the rates of complications for different procedures?
• What are the positive and negative impacts of different procedures?
• Are there any specific population groups who may be differentially impacted by cosmetic procedures?
• What regulatory approaches have been tried and what lessons can be learnt from these?

In October 2014 the Medline and Embase databases were searched for review articles in October 2014. Systematic review evidence was prioritised but individual studies were considered when no other available evidence was identified.

Overarching findings

The literature suggests there has been a very rapid increase in the use and variety of non-surgical cosmetic procedures that are used in high-income countries, but little robust data are available. Use of procedures appears most common amongst middle-aged women. However, there are indications that the target demographic may be expanding, with one author arguing that there should be a shift from asking 'when is it too early [to start treatment]?' to 'when is it too late?' [1].

In general, serious adverse events were reported to be exceedingly rare for non-surgical procedures, with most complications being mild and self-limiting. However, the quality of the evidence base for many non-surgical procedures was found to be poor. A high proportion of the scientific literature declared financial conflicts of interest, with many authors receiving funding from the manufacturers of cosmetic treatments. Overall, most studies report people are generally happy with the outcome of cosmetic procedures, although again noting the considerable limitations in the evidence base [2].

Several articles raise concerns about the marketing of cosmetic procedures. For example, one study investigated advertising of cosmetic procedures on Scottish websites [3]. Failing to adhere to marketing regulations was common (26 websites, 20.8%), with advertising of prescription only medicines on the homepage or dropdown menu (n=20) and offering enticements inappropriately (n=6). Over a quarter of websites did not display the qualifications of practitioners while only 16.6% of websites described the side effects of "anti-wrinkle injections" and 12.5% mentioned alternative treatments.

Botulinum toxins

The safety of botulinum toxin was investigated in a recent systematic review [4]. The authors identified 35 papers which provided a total of 8,787 subjects. The most investigated area was the glabella^[11] (51.4%), followed by the upper face (25.7%), crow's feet (11.4%), and lower face (11.4%). Adverse events included blepharoptosis^[12] (2.5%), brow ptosis^[13] (3.1%), and eye sensory disorders (3%) in the upper face and lip asymmetries and imbalances in the lower face (6.9%). In all cases, the events were reported as resolving without further treatment.

Dermal fillers

In general, the overall safety of dermal fillers appears good. In a retrospective study of medical records at a single American centre, 2089 injectable soft-tissue filler treatments were performed, comprising 1047 with hyaluronic acid, 811 with poly-L-lactic acid, and 231 with calcium hydroxylapatite [5]. Of these, fourteen complications were identified. Nodule or granuloma formulation was observed most commonly, with treatment using calcium hydroxylapatite having the highest complication rate. Cellulitis was seen in four patients and skin necrosis in one. The authors concluded that mild bruising, pain and swelling were commonly observed and expected side-effects, but true complications occurred rarely in their study.

Chemical peels and skin rejuvenation

Chemical peel and dermabrasion are two approaches to resurfacing the skin in order to bring about a more youthful appearance [6, 7]. Chemical peels are generally applied to a broad area of the skin (often face), while dermabrasion is most frequently used in the refinement and revision of scars as a local or 'spot' technique. There are typically three categories of chemical peel, based on depth: light, medium and deep (to generate a second-degree burn). Medium and deep chemical peels poses specific health risks while light chemical peels are safer but less effective. Patient selection was deemed to be important - with a past medical history of cold sores, herpes simplex virus and fever blisters being questions to specifically ask about. Following a deep peel, frequent post-procedure appointments are needed for the first two weeks, coupled with good wound care.

Complications of chemical peels and dermabrasion include herpes simplex, persistent erythema*, hypertrophic scarring*, pigmentation problems* and milia* [6]. Scarring following medium or deep peels has been estimated at 1% [8]. Caution is particularly necessary for people with dark complexion as deep peels bleach the skin and may result in hypertrophic scarring or keloid formation.

Lasers, IPL and LED

Lasers can be used for treating a broad variety of skin-related conditions [9]. Common uses of lasers include hair removal, vascular lesions, wrinkles, pigmented lesion, acne and tattoo removal. Complications from laser treatments that may occur, even when administered appropriately, include purpura^[14], hyperpigmentation, hypopigmentation, pain, erythema, oedema, blister formation, scarring, darkening of cosmetic tattoos and allergic reactions to liberated tattoo pigments [9]. It is also recommended that any pigmented lesion with atypical features should be biopsied to rule out the possibility for malignant degeneration.

A broader range of complications are possible if treatments are not delivered appropriately. Safe practice when using lasers is necessary, with errors posing considerable risks [10]. The administration of chlorhexidine may cause corneal ^[15]ulceration while the use of alcohol to clean skin, dry gauze, hairspray and make-up all lead to incendiary potential. In a survey of American dermatologic surgeons, 111/480 had seen patients with serious adverse effects from laser and light-based hair removal procedures by non-physicians, such as second- and third-degree burns, permanent nerve damage and scarring [11]. The majority of these severe complications were attributed to 'non-physician operators' ("such as cosmetic technicians, aestheticians, and employees of medical/dental professionals who performed various invasive medical procedures outside of their scope of training or with inadequate or no physician supervision").

Hair restoration surgery

Hair transplantation involves harvesting hair follicles from one part of the body to another. It has been most widely used to treat male pattern baldness and while its uptake appears to have increased recently, the procedure is not new [12]. Treatment involves harvesting hair follicles from a 'donor' site (typically elsewhere on the scalp, when treating male pattern baldness). Increasingly, micro grafts (one or two hair follicles) or mini-grafts (three or four hair follicles) are performed, with the treatment being time-consuming, as 1000-2500 grafts are often carried out per session.

Little robust evidence was found on complications, with identified review articles describing the range of complications possible, rather than providing quantitative estimates of rates of specific complications [13, 14]. Expert opinion noted that serious complications are uncommon if procedures are well-planned and well-performed, with temporary inconveniences (such as pain, pronounced oedema, temporary thinning within the surgical site, prolonged crust formation over operated areas and short-term hypo-aesthesia) far more likely. In particular, authors emphasised the importance of patient selection and pre-procedure counselling, with realistic expectations needing to be conveyed.

Table: Minimally invasive aesthetic procedures

Procedure	Indication	Treatments required and duration of action	Advantages	Disadvantages
Botulinum toxin A	Dynamic facial lines and wrinkles in the upper one third of the face	One treatment every three to four months	Short procedure time, dramatic results	Small margin for technical error with injection placement; high patient expectations
Dermal filler injection	Facial wrinkles and folds in the lower two thirds of the face; lip enhancement	One treatment every three to 24 months; duration of action varies with product composition and treatment area	Immediate results	Post-procedure swelling and bruising; injection proficiency and consistency of outcomes require practice
Laser hair reduction	Unwanted hair	Series of six treatments with at least one-month intervals; long-term reduction in hair growth of 50 % or more	Faster and less painful than other methods of permanent hair reduction, such as electrolysis	Risk of burns, hyperpigmentation, and hypopigmentation (particularly for people with darker skin); reduced effectiveness with fine, lighter-coloured hair
Laser photo-rejuvenation	Benign epidermal pigmented and vascular lesions	Series of two to five treatments every two to four weeks, based on severity of lesions and device used; results last up to several years	Highly selective for lesions without damaging surrounding skin	Risk of burns, hyperpigmentation, and hypopigmentation, particularly for people with darker skin
Micro-dermabrasion	Benign epidermal pigmentation, rough skin texture, acne, fine lines, superficial acne scars	Series of six treatments every two to four weeks with monthly or quarterly maintenance treatments; short-term Results	Safe for all skin types; few absolute contraindications	Worsening telangiectasia and erythema possible; minimal change with single treatment
Chemical peels	Benign epidermal pigmentation, rough skin texture, acne, fine lines, superficial acne scars	Series of six treatments per month with monthly to quarterly maintenance treatments; short-term results	Inexpensive: can give good results depending on patient selection, depth and clinician competence	Less control over depth of exfoliation; post procedure skin peeling; minimal change with single superficial treatment; risk of scarring, hyperpigmentation, and hypopigmentation with deeper peels
Hair transplant	Hair loss	Can be performed as a one-off but repeated procedures may be needed	Effective treatment	Time-consuming and expensive; broad range of potential complications; requires availability of hair follicles from a donor site

b) Analytical Programme for Evidence Gathering

The IEP subgroup noting the lack of information available from routine sources, committed to an Analytical Programme for Evidence Gathering which includes five different mechanisms of primary data collection to find out about current cosmetic procedure uptake, benefits and risks in Scotland.

The analytical framework was developed and delivered by the Health Analytical Services Division (ASD) in the Scottish Government. When appropriate the different data collection methods mechanisms were piloted with the general public. The specific objectives for the evidence gathering process and the methods agreed are shown in Annex 4.

As part of the analytical programme an Omnibus survey^[16] was commissioned from YouGov (Executive summary in Annex 5). A number of focus groups took place across Scotland run by the Scottish Health Council^[17]. These provided evidence on the Scottish population's views, knowledge and experience of cosmetic interventions. Additionally two separate online surveys were conducted with consumers and with providers of cosmetic interventions in Scotland (tables with detailed results are available from the SCIEG secretariat). Lastly, a number of questions on cosmetic interventions has been introduced into the Scottish Health Survey (a repeated cross-sectional survey) which will provide a baseline for monitoring prevalence and developments of cosmetic interventions in Scotland.

While the results from the Omnibus survey are representative of the Scottish population, the focus groups and online surveys are more limited in this respect as those samples include a large proportion of self-selected respondents. Moreover, the number of responses for the questionnaires was low, with 37 people responding to the consumers' questionnaires and 43 people responding to the providers questionnaire. Therefore the evidence provided from the online surveys and focus groups needs to be considered with caution.

1) The consumer perspective: Summary of findings from the Omnibus survey, focus groups and online survey.

The Omnibus survey asked a question on was how familiar are you, if at all familiar with the following cosmetic procedure. For breast implants the responses were:

Not at all familiar	15%
Just heard the name	31%
Somewhat familiar	40%
Very familiar	12%
Don't know	3%

So while 82% are aware, just 51% were somewhat or very familiar. The assumption of the latter is those who are somewhat or very familiar have an understanding of what is involved in the procedure.

Using these answers the Omnibus survey found a significant proportion of the adult Scottish population were somewhat familiar with a range of cosmetic procedures, with the most common being:

• Cosmetic dental treatments (53% of population)
• Breast enlargements / reductions (51%)
• Nose jobs (47%)
• Surgical liposuction / sculpture (46%)
• Surgical neck/ face lifts (39%).

The Omnibus survey found that 4% of the adult Scottish population reported having had a private cosmetic procedure in their lifetime (varied between 3% in the 18-24 age group and 7% among the 25-34 age group), of which:

• 54% have had a cosmetic dental treatment
• 17% have had an injectable cosmetic treatment
• 16% have had a laser skin procedure

In the adult Scottish population:

• 1% had a cosmetic procedure in the last 12 months
• 4% plan to have one in the next 12 months

The ethnic group spilt followed nationally representative proportions of white and minority ethnic groups in the Scottish adult population ie 4% of those who has a cosmetic procedure are in the minority ethnic group, 96% in the white ethnic group. Geographically the split of those who have had a cosmetic procedure follows the population spread although those who had a procedure and live in Glasgow, are a larger proportion than the Glasgow residents are in the national population split (ie 18% compared to 12% in the national adult population).

The online survey shows that the most frequently used cosmetic procedures are non-surgical, with the exception of breast implants and laser eye surgery (note that many consumers had received more than one type of procedure):

• 70% injectable such as botulinum toxin (n=27)
• 60% dermal fillers (n=23)
• 20% injectable cosmetic dental treatments (teeth whitening or veneers) (n=9)
• 10% breast enlargement (n=3)
• 10% laser eye surgery (n=4)

The Omnibus survey asked which sources people would use to find information on cosmetic procedures, the results show that most would use their GP (50%) or do an internet search (49%), accessing specific websites such as the NHS Scotland (40%) or NHS Choices (29%) was also common. Around a fifth (21%) would use friends of family and a tenth (11%) use articles in newspapers or magazines.

The focus groups found people had good knowledge of cosmetic interventions, usually gained through newspapers, magazines, social media or friends' experiences. Most participants in the focus groups would make a judgement on the reputation of services through word of mouth and sharing of experiences with friends.

There were clear messages from the focus groups that advertising which used young attractive people could play on peoples insecurities. One person commented "it is outrageous and very misleading. Most look like they are from the same mould, airbrushed. Men would see this and think it is normal and girls would look at this as what they should look like". It was felt that the full implications of the procedures were never shown in advertising or marketing with no scars or swelling shown in photos.

In terms of who performed the procedures that consumers had, the online survey provided a mixed picture:

• Nurses and doctors were the most common providers of botulinum toxin (for example 'botox®') and dermal fillers, while beauty therapists and nurses provided similar amounts of the skin rejuvenating treatments such as chemical peels, microdermabrasion and skin resurfacing.
• Cosmetic dental treatments were mainly provided by dentists but almost 30% of procedures were provided by beauty therapists
• A quarter of non-surgical face / neck lifts were provided by doctors, three quarters by nurses (n=4).

The focus groups felt that doctors should do most of the work but were more accepting of the second procedure being delivered by a nurse.

Looking at consumers' experience of their treatment the Omnibus survey found over three quarters found their most recent private cosmetic procedure had achieved what they expected (78%). This is similar to the online survey which found that 75% found their service satisfactory, with the main reason (40%) for a lack of satisfaction being the procedure not making enough difference to their appearance. The benefits of procedures were mainly, according to the focus groups, "to give you a boost, makes you feel better, look better" and could help with jobs.

On reported health problems in the first month after a private cosmetic procedure more than a quarter (27%) of the Omnibus responders reported difficulties such as slow healing, bleeding or numbness.

On complaints, the Omnibus survey found the first point of contact if something went wrong would be the provider (40%) but with 22% saying their first point of contact would be the GP and 8% saying a solicitor. The view from the focus groups was that people did not always know where to go to complain. This seemed to be especially the case for some minority groups - Asians reported being less likely to complain as they had less knowledge of where to complain. This finding was echoed by the Omnibus survey, with 7% of adults belonging to minority ethnic groups saying they would turn to a hospital first, compared to 3% of white adults.

The online survey found that:

• 40% of those dissatisfied did not make a complaint
• 60% found out about their provider through word of mouth

In terms of their experience of consent, the online survey responses showed that:

• 100% felt they were able to make an informed choice with the information they were given. However only 61% were given written information on what might go wrong with the procedure
• 96% were asked for verbal consent
• 90% were asked for consent in writing

It should be noted that SCIEG members, as well as other approaches, were used to disseminate the survey and therefore the sample is likely to be atypical.

Some of the focus group participants thought patients should perhaps have a psychological assessment before surgery or consider other ways to think about how they view themselves, and then assess the options available. Others felt they benefited from attending some group meetings prior to the procedure to learn about what was involved. One comment from the focus groups was "anything that is done to the body needs to be explained in detail and may take longer to explain from start to finish with someone with learning disabilities" It was also noted that regular customers would already have built up a relationship with staff and have confidence in the service.

It was found that people's beliefs in terms of regulation and qualifications in this sector do not match the current situation in Scotland. The Omnibus survey found that: 43% believe cosmetic surgery is regulated, 39% believe cosmetic dentistry is regulated, 12% believe non-surgical cosmetic procedures are regulated - but these figures differed by age with young adults (18-29 year olds) and those with no formal educational qualifications being more likely to believe that non-surgical services are regulated (24% and 19% respectively). The online survey showed that: 60% of people think that currently all non-surgical cosmetic services are registered with an independent regulator and also that there is a regular inspection of services.

People showed strong support for the regulation of the sector with views from the online survey showing that 75% of people thought that there should be minimum training standards for staff and 65% of people supported a requirement to have insurance which provides compensation to customers if things go wrong with their procedures. This was supported by views from the focus groups.

There was a general consensus across the focus groups that providers of cosmetic interventions should be regulated. There was surprise at the lack of regulation with comments such as "you would think that if you had to deal with injections that you would have some training/licence to practice". There was a view that there had to be accountability on the part of the provider. For example if a procedure went wrong under the NHS it would be expected that the NHS would meet the cost of rectifying the mistake. But was this the case in the private sector? The same standards were expected for private practitioners as for the NHS. Participants thought there should be a regulatory body to inspect clinics and make sure they are meeting the required standards and have the power to close them down if they don't.

There was a mixed response as to whether there should be any age restrictions for receiving cosmetic procedures. Some felt older people could be manipulated or younger people may not be emotionally mature enough. Others thought each case should be assessed on an individual basis.

There were strong views about whether the NHS should treat people unhappy with the outcome of their procedures: "absolutely not"; "yes but then seek the costs from where the original surgery took place"; " why should we pay for someone's incompetence?" There was agreement that the NHS should provide treatment for medical emergencies and sometimes the NHS has a greater role. For example, in the case of the PiP breast implants, to remove the implants, but not to provide treatment if it was not an emergency and had no medical indication.

This was also borne out by the Omnibus survey which showed that 67% did not agree that it is acceptable for the NHS to cover the costs of caring for someone whose private cosmetic procedures has gone wrong. Again however there was a marked difference between the age groups with more young adults (48%) agreeing with the principle that the NHS should cover these costs.

2) The provider perspective: Summary of findings from the surveys, and discussions with the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Scottish Colleges representative.

• The large majority of providers undertake non-surgical procedures, with 25% of respondents doctors (60% surgeons, 30% GPs) and the rest mainly nurses and dentists.
• The age ranges of people that use these services are generally similar for surgical and non-surgical. While consumers' ages ranged widely, providers reported mainly delivering services to people in their late 30s to late 50s, with some services given to people in their 20s and 30s. This is supported by the results from the Omnibus survey which shows that 13% are in the 18-29 age group, 29% are in the 30-49 age group, 40% are in the 50-69 age groups and 8%% are in the 70 plus age group.
• Both males and females are clients, using a similar mix of surgical and non-surgical services, with male clients seen less often. This is corroborated by the results from the Omnibus survey which found that 71% of those who had a cosmetic procedure in their lifetime are women, 29% are men.

From the online survey it was noted that:

• There was an interesting spread of premises used for delivering procedures, especially for non-surgical (20% in clients' homes).
• Very high consent rate and high levels of refusal in both surgical and non-surgical provision: 60% of providers sometimes refused potential consumers of surgical services, 75% sometimes for non-surgical. The overwhelming reason for refusal was procedure being unlikely to meet client's expectations; although for non-surgical services, a significant proportion (30% of refusals) was due to the client having another medical condition (including pregnancy).
• 100% of surgical providers reported they routinely arrange a follow-up appointment, and 75% of non-surgical providers.
• Of all the providers, 40% offered deals or discounts once or twice in the previous year, and 10% every couple of months for non-surgical procedures.

The survey also provided views on regulation from providers:

• There is a high compliance with indemnity insurance in this self-selected sample of providers
• Amongst providers, 75% think the overall level of regulation for cosmetic services is too little.
• Regular inspections were thought to be necessary by a majority responding to the questionnaire, with inspection required for both premises and practitioners.
• There were differing views on the amount of regulation required in free text responses to the questionnaire, although the majority still favoured more regulation.
• 90% have qualifications for cosmetic interventions, with the most common (30%) being a certificate course lasting less than 2 days.

The MHRA reported that from their adverse incident database there were 194 adverse incident reports for dermal fillers and 2,702 reports for breast implants between 1 October 2009 and 1^st October 2014. Inclusion in the MHRA adverse incident database only indicates a report has been received and cannot be interpreted as a summary of known or proven adverse reactions to the device^[18].

It is estimated that Scotland produces up to 1,400 beauty therapists a year, according to figures provided on the entry rate to all Scottish Colleges for beauty and hairdressing and specific figures on types of courses and pass rates from one specific college. This excludes those who may gain qualifications through a private training provider.