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Don't let cosmetic surgery stitch you up

New 'Evidence Pyramid' unveiled to evaluate science v hype in new techniques

Research unveiled today at the Annual Scientific Meeting of the British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk) shows that despite a rise of 8,000% in cosmetic surgery reporting in the mainstream media over the last twenty years, many products and techniques promoted directly to the press and public actually have very few, if any, published scientific articles behind them.

A new study presented at the conference which looked into some of the most popular treatments not only found clinical papers on them to be scarce, but those studies that did take place followed very low numbers of cases (one trial just tracked two patients) usually for a very short amount of time, and well over a third of the authors involved admitted to conflicts of interest. The BAAPS is calling for the media and public to use a measuring system similar to those used in surgical journals which ‘grades’ the levels of evidence behind new procedures and claims.

Research* presented at the conference reveals that in 1991 there were only 45 articles in national newspapers dealing with cosmetic surgery – by 2013 there were 3,568 (nearly 10 per day), a rise of 7,900%. Yet when the amount of mainstream coverage achieved by just four of the most popular aesthetic devices was twenty-four times the number of clinical papers** behind them (almost 600 articles in the consumer press, v just 25 in medical journals).

Yet even the actual peer-reviewed data can be surprising if examined in detail – the study’s evaluation of high-profile non-invasive liposuction technologies showed the number of patients studied varied wildly: from just two cases to a few hundred (only 16% involved more than 100 and more than half involved <50), and all but one were based on less than six months’ follow-up. Only one trial followed patients for five years (just two patients, however). In addition, more than a third (36%) of authors disclosed a financial or conflict of interest – which means the device company either made a payment, provided the equipment or the author has a financial interest in the business.

The way the surgical arena evaluates – even early or experimental – data published in respected outlets such as the Aesthetic Surgery Journal (ASJ) and the Plastic and Reconstructive Surgery (PRS) is by using a colour-coded ‘Evidence Pyramid’ which classifies the level of research behind study conclusions. These can range from the most basic expert opinion or claim (lowest tier) through to small studies, then more exhaustive trials and long term analysis (highest). The Pyramid is being presented to surgeons today at the conference, and in turn the BAAPS is offering a simplified version for the media and public to be able to accurately gauge the amount of proof behind new product claims.

According to consultant plastic surgeon and outgoing BAAPS President Rajiv Grover;

“We know that due to the ‘normalisation’ and growing acceptance of aesthetic treatments there has naturally been a stratospheric rise in media reporting in this area. Journalists in the consumer press have had their work cut out - increasingly addressing issues such as risks, complications and the importance of regulation in the sector. I don’t envy the challenges of reporting credible developments from such a murky field, but that doesn’t mean the cosmetic surgery sector should be allowed to stitch people up.”

Media reports of complications and regulation in cosmetic surgery have risen by over 17,000% and 20,000% since 1991, respectively. Three quarters of consumer press coverage involves publicity driven by a commercial provider or practitioner offering the treatment and 15% involved celebrity endorsements.  Rajiv continues;

“As the research presented today shows, much of what is communicated will inevitably be led by manufacturers, commercial providers or individual practitioners, occasionally making grandiose claims. In the clinical world, there is widespread use of ‘tiers’ which allow us to determine how much research backs findings, so we can make informed decisions based on evidence that goes further than skin deep. However, without a similar filter, there are pitfalls for those who might be swayed by weak data, manipulated photos or paid-for celebrity endorsements. There urgently needs to be a traffic light or warning system for new devices and techniques promoted to the public.”

The pared-down version of the Evidence Pyramid (the fully detailed one used by journals being presented to surgeons at the conference) broadly offers four levels of ‘evidence’:

Top tier:

•      Has been studied for more than 5 years, easily researchable with more than 50 non-sponsored studies in medical/scientific journals

•      Examples include botulinum toxin (commonly known as Botox), and cohesive gel implants

Second tier: 

       Has been studied for between 2-5 years and has more than 20 non-sponsored studies in medical/scientific journals

       Examples include the CoolSculpt (fat freezing) device and surgical facial treatment ‘Silhouette Lift’

Third tier: 

       Has been studied for at least a year, with a minimum of 5 non-sponsored papers in medical/scientific journals

       Examples include novel fat transfer technique ‘nano-grafting’ and body contouring filler Macrolane, which was taken off the market after being promoted for use in the breast

Below Surface (or ‘BS’) level:

       Has been studied for less than one year and may be based on a single case study. Information on the treatment is found almost exclusively via promotional channels rather than presented to peers via scientific conferences or publications

       Vague or unrealistic claims ‘Boob Job Serum’, ‘Electrode Facelift’, ‘[Insert celebrity name] Lift’, ‘Fat dissolving/melting/zapping/bursting’

 

Rajiv concludes;

“Whilst arguably many long-established, proven techniques started with an adventurous expert opinion and one humble case study, it’s only fair for people sampling a product billed as ‘boob job in a bottle’ or ‘lipo in a can’ to be aware of how much real scientific evidence has been established first. This is where the Evidence Pyramid (or ‘BS Filter’) comes in – it is, at its most basic, a call for common sense and a reminder to ask questions. When was the treatment launched? How many people were involved in trials and for how long were they followed? Where has the data been published or presented, and was it sponsored (paid for)? This is an invitation for journalists and the public to cut into bombastic claims – even from surgeons!”

 

According to Preston-based consultant plastic surgeon and BAAPS trainee member Reza Nassab, who conducted the studies titled ‘Evidence-Based Hype’ and ‘Cosmetic Surgery in the Press’;

“The evidence supporting many new devices is of low level and the results are variable. The public may not be aware of all research findings and results – increased education is needed to ensure people understand treatments may not be as effective as portrayed in their marketing materials. Organisations such as the BAAPS and the new National Institute for Aesthetic Research are ideally placed to promote education in this area.”

The National Institute for Aesthetic Research (www.niar.org.uk) was launched a year ago as a joint initiative by the BAAPS and leading charity the Healing Foundation.

According to consultant plastic surgeon and new BAAPS President Michael Cadier;

“New so-called ‘clinically-proven’ treatments promising unbelievable results are launched almost on a daily basis. We believe that asking the right questions, doing a bit of research and engaging in a dose of scepticism is the healthiest approach for the public.”

*via LexisNexis

**via PubMed

 

ENDS

The BAAPS (www.baaps.org.uk), based at the Royal College of Surgeons, is a not-for-profit organisation, established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit. Members undergo thorough background screening before they can join. Information about specific procedures and surgeons’ contact details can be found on the website, or by contacting their office at 020 7430 1840. Further materials can be posted to members of the public seeking specialised information. BAAPS is also on Twitter: www.twitter.com/BAAPSMedia  and Facebook: www.facebook.com/BritishAssociationofAestheticPlasticSurgeons

For all media enquiries, please contact pr@baaps.org.uk

 

 

 

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