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Plastic and Not So Fantastic - New Cosmetic Surgery Regulations
Posted on Jun 13, 2013 by Sergio Ulloa (G+)
Cosmetic surgery is big business in the UK. According to the British Association of Aesthetic Plastic Surgeons (BAAPS), the number of facelifts, liposuction procedures, nose jobs and other surgical cosmetic operations in the UK totaled 43,172 last year, and the industry is predicted to be worth £3.6 billion in the UK by 2015. As cosmetic procedures are very rarely available on the NHS, those wanting to undergo cosmetic operations have to do so at their own cost, and must also conduct individual research to find suitable private clinics and surgeons.
There is no shortage of plastic surgery providers. Indeed, the increasing demand for cosmetic treatments has seen a staggering rise in cosmetic surgeons and, up until now, very little in the way of regulation and legislation to monitor and control their practices.
With increasing reports about how cosmetic procedures can have major impacts on health and wellbeing, the Department of Health was asked to step in and write a detailed review of the existing Regulation of Cosmetic Intervention in order to assess the existing policy and regulatory framework. At the end of April this year, Professor Sir Bruce Keogh, Medical Director of the National Health Service, published this review which highlights concerns regarding the safety standards of the cosmetic surgery industry in the UK. In particular, the report stressed the need for more governmental oversight, to bring plastic surgery closer in line with other British health and consumer practices.
This surprising lack of regulation was first highlighted by the PIP silicone breast implant scare which hit British (and international) headlines last year. There were reported health risks for up to 47,000 British women who had undergone breast augmentation or breast reduction operations and were fitted with PIP silicone implants (including one purportedly related death from cancer). The silicone implants were later found to have been produced with in-house manufactured industrial-grade materials, instead of the required medical-grade silicone. This revelation drew attention to the potential health risks associated with cosmetic surgery, and highlighted fact that there was very little in the way of protocol for the private companies providing surgical procedures and products.
Despite the PIP case, breast augmentation remains by far the most popular cosmetic procedure in the UK, with just under 10,000 operations in 2012. In response to this, the recently published Regulation of Cosmetic Intervention stated that over the next 12 months, a breast implant registry needs to be introduced in the UK with the aim of collecting the names of people who have undergone breast augmentation surgery, along with information about their implants to enable the Department of Health to have much more comprehensive data about the numbers of procedures and their locations. This way, if there was another quality and safety issue with implants or any other products or practitioners, patients could be notified quickly and directly. Initially, the register will record breast implant operations, but the intention is that it will soon be expanded to include other cosmetic surgery procedures.
Even more pressing than issues surrounding cosmetic breast operations was the review's focus on the filler products which are used in anti aging procedures to treat wrinkles, lines and folds. In the review, Bruce Keogh states that "dermal fillers are a crisis waiting to happen" because at present, there are no regulations controlling what products can and cannot be used as fillers and because anyone can buy syringes and fillers online. In the United States, only six fillers are licensed for use and they are classed as medicines by the Food and Drug Administration, but in the UK, there is no such list of approved products - and it is estimated that up to 130 different fillers are available. The UK review makes a strong recommendation that cosmetic implants like dermal fillers be added to the EU Medical Devices Directive, whereby all fillers would be classified as prescription-only medical devices. This will mean that in the future, dermal fillers should fall under the same controls as other implants, to ensure that only those fillers that have passed strict safety tests will be available to buy.
In addition to reviewing the quality of the products used in surgical and nonsurgical cosmetic procedures, the Regulation of Cosmetic Intervention review also calls for a thorough re-evaluation of the qualifications and skills required by those administering cosmetic procedures. Again, particular attention goes to filler injections because there is currently so little legislation that those selling and performing filler injections do not need to be qualified or even adhere to any code of conduct. While members of the public tend to be less wary of these non- surgical procedures, because they are not classed on the same level as surgical cosmetic surgery procedures, there is still an enormous risk involved. According to research by the British Association of Aesthetic Plastic Surgeons (BAAPS), there has been a rise in complications related to the use of fillers. Therefore, as a priority, the review asks that those training to be non-surgical practitioners should have a clear understanding about the importance of safe premises, and the responsibilities involved. In addition, the HEE will have to develop accredited qualifications for individuals and establishments which administer non-surgical treatments.
The review is also concerned with ensuring the skills and qualifications of cosmetic surgeons after a poll conducted by the Patient Liaison Group at the Royal College of Surgeons showed that most patients would not check the qualifications of a surgeon before consenting to an operation. The review recommends that in the future all practitioners must be registered centrally, and that The Royal College of Surgeons (RCS) set up an Interspecialty Committee on Cosmetic Surgery in order to ensure certain standards for training and formal certification for those working in the field.
Finally, the review identified the health risks of cosmetic procedures becoming normality in British society. Cosmetic operations and non surgical procedures which have been been regarded as big decisions in the past have now become quick beauty fixes which can be done during lunch hours or even at group parties. The cosmetic industry also contributes to this casual image by encouraging customers with marketing and advertising strategies like time-limited deals, financial inducements and package deals such as "buy one get one free." The Regulation of Cosmetic Intervention found these deals generally 'distasteful' and wrong for trivialising important decisions about surgery. It states that the amount of information available to the public is often misleading and therefore called for a code of ethical practice to ensure that advertising is conducted in a socially responsible manner, and does not encourage vulnerable people to make rash medical decisions without thinking about the long term health implications.