Following the recently published Keogh report reviewing cosmetic interventions in England, the talk of the town has been dermal fillers, both in terms of scrutinising the safety of the products themselves, as well as the people who want to administer them to the paying public. One of the main recommendations from Sir Bruce Keogh’s report was that dermal fillers should be made prescription only medical devices (this is distinct from prescription only medicines such as botulinum toxins).
So on 15th May 2013, the governance board of the Treatments You Can Trust Register of Cosmetic Injectable Providers (www.treatmentsyoucantrust.org.uk) assembled a panel of experts at the House of Lords for a meeting to discuss the ways to take the agenda forward on dermal fillers in conjunction with other stakeholders such as the MHRA and product manufacturers, whilst the Department of Health (the government department who will ultimately be responsible for any ‘action plan’ on fillers) formulates its implementation plans for later this year.
TYCT Chairman, Baroness Trish Morris of Bolton OBE DL oversaw contributions from Dr Andrew Vallance-Owen, a member of Sir Bruce Keogh’s Cosmetic Interventions Review team, John Wilkinson, Director of Devices at the MRHA, Dr Patrick Bowler, Co-Founder and Fellow of the British College of Aesthetic Medicine, and leading manufacturers including Tania Geldard, Regulatory Affairs Leader for Medical Devices for Allergan (maker of Juvéderm®), Lifestyle Aesthetics (on behalf of Teoxane, the maker of Teosyal®) and Merz Aesthetics (maker of Belotero® and Radiesse®).
The meeting also included an audience of industry leaders, members of the Department of Health Keogh Review Implementation team, the General Medical Council, the British Dental Association, practicing practitioners, press and TYCT Governance Board members.
Sally Taber, TYCT Director said of the meeting; “The very fact that the Department of Health Implementation team came to listen to the views of the industry demonstrates a willingness to engage with and listen to all stakeholders as the recommendations are considered. There is an industry wide consensus that patient safety should not get overlooked and in the meantime TreatmentsYouCanTrust.org.uk can continue to deliver this whilst also acting as a template and a working register with a set of high standards that ensure best practice.”
With Keogh recommending that dermal fillers be prescription only medical devices there was need for some definitions of what this actually means.
Currently dermal fillers do not automatically fall within the definition of medical devices, but under proposals for revising the EU legislation, they will. Although, it is worth noting that most dermal fillers that are used in the UK by reputable clinicians (the primary brands shall we say) have been subject to the medical devices regulatory process. Changing dermal fillers to become prescription only (medical) devices will require primary legislation which will take time to go through the legislative framework; however if this takes place it is felt that it will contribute to greater control over who is allowed to use dermal fillers. It was noted that this kind of legislative change has been rarely done before, but an example quoted to show that it is possible is with the case of prescription only glasses (which are a device).
John Wilkinson OBE, Director of Devices at the MRHA said; “A medical device is any instrument, apparatus, appliance, software, implant, reagent or other article, intended by the manufacturer to be used for one or more specific medical purposes. Under current legislation, not all dermal fillers fit into this definition. Legislative proposals set before the European Parliament will include dermal fillers along with other categories of products that serve cosmetic purposes to be regulated as if they were medical devices.”
The meeting also discussed several key points including the need for diligent data collection and recording within the industry to enable traceability and accountability of individual filler products, to monitor the number of filler treatments carried out and the number of providers and for there to be improved reporting of incidents where an adverse reaction occurs.
Dr Andrew Vallance-Owen, Member of the Keogh Cosmetic Review Team said; “The review recommendations cover a broad scope; however what is central is the ambition to make patient safety paramount and to ensure consumers are empowered to make a choice. The lack of available information on the number and descriptions of dermal fillers injected demonstrates the clear need for better data collection. Whilst we wait for the Government’s response to the Review and for the recommendations to be implemented, it is important that safety measures remain in place and Treatments You Can Trust should continue to do this.”
The resounding sentiment from the meeting was of a need for cohesive working within the industry to ensure the agenda of patient safety is taken forward and prioritised; this was highlighted by the willingness of manufacturers to work with organisations like TYCT to improve the industry.
Of those who attended the early morning meeting many took to Twitter to post their observations and thoughts on what was being discussed. Interesting points raised included one from Natasha Devan, Editor of the Journal of Aesthetic Nursing who raised the point that there was ‘lots of talk of the importance of health professionals administering (dermal fillers)’, yet this is in fact contrary to the actual Keogh report which seemed to recommend opening the doors to all, provided they had an ‘accredited qualification’ and were ‘supervised’. It will be interesting to see if the DOH Keogh Implementation team decide to take heed from the industry and backtrack on that recommendation or not. One to watch!
We should expect to see an implementation report from the Department of Health before their summer recess begins in mid-July.