Sir Bruce Keogh Cosmetic Surgery Review: Response

Following the fall-out from the PIP breast implant scandal during 2011-2012, which brought the cosmetic surgery industry to the forefront of public awareness and concerns, the Health Secretary Andrew Lansley asked the Department of Health to investigate the whole industry. This job was given to NHS Medical Director, Professor Sir Bruce Keogh along with an expert panel and was officially launched on 15th August 2012 with a ‘call for evidence’ which ran until 15th October 2012.

The ‘call for evidence’ was designed to include experiences and views from both the industry and patients in order to assist the inquiry. It asked for people’s views on the regulation and safety of products used in cosmetic interventions; how best to ensure that the people who carry out procedures have the necessary skills and qualifications; how to ensure that organisations have the systems in place to look after their patients both during their treatment and afterwards; how to ensure that people considering cosmetic surgery and procedures are given the information, advice and time for reflection to make an informed choice; and what improvements are needed in dealing with complaints so they are listened to and acted upon.

On 31st December 2012, the Department of Health published details of the responses to the call for evidence. They received over 180 responses from a wide range of individuals and organisations, which broke down as 63% individuals (either professional working in the sector or member of the public), 10% industry bodies, 6% professional bodies, 4% charities, 4% private providers, 4% regulators, 3% insurers, 2% devolved administration, 2% manufacturers, 1% lawyers and 1% membership.

The DOH noted that the report was designed to present the key messages received from respondents on the various themes discussed; however they point out that “this summary cannot cover in detail all the responses or reflect all the perspectives put forward, nor is it intended to present an indication of the Review Committee’s emerging recommendations However, all responses have been analysed in depth and the data and evidence supplied will be used to inform the final recommendations, which are due to be published at the end of March”.
 
The summary document states that there were a wide range of views on the future regulation of cosmetic interventions but some consistent key messages emerged from respondents. These included:

• the current regulatory framework was inconsistent and did not reflect the many changes and innovations in such a fast-growing and dynamic sector
• training requirements were felt by many to be disproportionately weak compared to the potential risks of a procedure and more specialised training was welcomed
• dermal fillers and intense pulsed light and laser procedures were highlighted by many as an area where there was insufficient legislation to protect the public
• respondents were concerned about the lack of data being collected on implants, procedures, adverse incidents and outcomes
• the Review was timely and an important part of restoring public trust in the cosmetic interventions sector following the issues with PIP breast implants

The summary report also highlighted some of the suggestions put forward by respondents which they wanted to see implemented by the Review recommendations. These included:

• banning free consultations for cosmetic surgery so that people don’t feel obliged to go through with surgical procedures
• ensuring consultations are with a medical professional, not a sales adviser
• imposing tighter restrictions on advertising including banning two-for-one, time-limited deals and cosmetic surgery as competition prizes
• requiring a two-stage written consent for surgery so people have time to reflect before making a decision
• providing better information for patients including photos of expected bruising and scarring, and more detail on the risks associated with surgery

Of more interest to the non-surgical sector of the aesthetic marketplace were the sections of the report which focused on responses in relation to dermal fillers and lasers and light treatments. This showed that many respondents felt that the current regulation of fillers was inadequate and tighter regulations were needed in terms of both the safety and administration of the product, as well as a need for greater regulation of lasers and light treatments given the potential risks to consumers.

There was strong support for tighter regulation for fillers used in cosmetic interventions. Most respondents felt that those not currently treated as a medical device, because they only had cosmetic and not medical applications, should be reclassified as devices. It was suggested that this could be done through revisions to the EU Medical Devices Directive but some felt something needed to be done sooner and that the Government should act to reclassify them as prescription only medical devices.

Some respondents also called for manufacturers to be required to tell the Medicines and Healthcare products Regulatory Agency (MHRA) or Notified Body when they brought a new filler product to market in the UK to help ensure better surveillance of product safety. Some suggested that new devices should be subject to the same surveillance processes as new medicines through the MHRA ‘Black Triangle Scheme’.

Respondents all agreed that those administering fillers should be required to have some kind of accredited training but there were differing views about whether the administration of them should be restricted only to certain healthcare professionals, all healthcare professionals or all those who have undertaken accredited training. There were also concerns that any legislation in this area would need to keep pace with new and emerging procedures such as ‘vampire facelifts’ or injectable stem cell treatments.

The regulation of laser equipment was felt to be inconsistent and not in line with the possible risks of improper use. For many, the growing popularity of these treatments increased their concerns about unscrupulous or ill-trained providers springing up to take advantage of consumer demand.

There were concerns that laser and light treatment providers were no longer regulated by the CQC and some respondents felt that there had been an increase in adverse incidents (mainly burns) as a result. Trading Standards and Environmental Health officers do inspect some premises but resources make it very difficult for this to be a priority and some highlighted that the nature of such inspections were better suited to a healthcare regulator.

A large number of respondents suggested that accredited training for practitioners should be made mandatory. Some noted that insurers had withdrawn cover for beauty and dental therapists due to concerns about risks. Most respondents said that performing laser and light treatments didn’t need to be restricted to medical professionals only.

Commenting in the report, Sir Bruce Keogh stated; "The responses to the Call for Evidence send a clear message that the current regulatory framework doesn’t do enough to support consumer rights or patient safety. The supply and demand for procedures in this fast-growing sector has outgrown the existing legislation around the products used, the people providing treatments, and the information and advice available to the public.

Over the next few months we’ll be using information gathered from the Call for Evidence alongside our engagement with the sector to formulate our recommendations. I hope what we propose will deliver a cosmetic interventions industry that will lead the world in terms of patient care without stifling consumer choice.”

The full report is available at:
www.gov.uk/government/uploads/system/uploads/attachment_data/file/126843/Call-for-Evidence-Summary-Report1.pdf.pdfdf