COSMETIC treatments such as dermal fillers and Botox injections will be more strictly regulated in England under new government plans.
The move follows concerns raised in an independent review last year, led by Sir Bruce Keogh, that dermal fillers could cause lasting harm but were covered only by the same level of regulation as ballpoint pens.
The government has promised to more carefully regulate the industry, which will be worth an estimated £3.6 billion by 2015 and is dominated by non-surgical procedures such as dermal fillers, Botox and laser hair removal.
In its official response published yesterday, the government said it “fully accepts the principles” of the Keogh review and the “overwhelming majority of its recommendations”. Discussions are ongoing with administrations in Scotland, Wales and Northern Ireland in the hope all four countries will support the measures.
Under the new rules, people providing injectable anti-ageing treatments will have to undergo specific training. Recommendations on the training and qualifications required will be published by Health Education England in April. Those administering fillers will have to do so under the responsibility of a named doctor or nurse.
But while Botox is currently prescription-only, the government stopped short of introducing UK legislation classifying dermal fillers as such – a decision branded a “missed opportunity” by surgeons.
The government’s response instead voiced support for proposals put forward by the European Commission in September 2012 to extend the EU medical devices directive to cover all cosmetic implants, including dermal fillers. If the proposals are accepted, dermal fillers would become subject to controls by UK medicines regulator the MHRA.
Other measures include the launch of a new register to record every breast implant operation. This follows the recent PIP breast implant scandal in which a lack of records meant some surgeons were unable to tell which patients had been fitted with the substandard products.
The government is also keen for patients to receive “independent and evidence-based information” to help them make informed decisions about treatments. The report adds: “Redress is a key theme here and we are looking at this in more detail.”
In terms of patient consent, the government said it supports a “multi-stage consent process” in line with current NHS practice. This means consent could be sought by an operating surgeon, rather than the lead operating surgeon.
The Royal College of Surgeons has also taken action by setting up an inter-specialty committee to ensure standards for cosmetic surgery. They will work with the General Medical Council on a code of ethical conduct.
There will also be a tougher stance on irresponsible advertising with the help of the Advertising Standards Authority.
Despite the measures, the response document has been criticised by the British Association of Aesthetic Plastic Surgeons (BAAPS) who said they were “appalled at the lack of action taken”, adding: “This review… represents yet another thoroughly wasted opportunity to ensure patient safety.”
BAAPS president Rajiv Grover said: “With all the evidence provided by the clinical community, choosing not to reclassify fillers as medicines with immediate effect or setting up any kind of compulsory register beggars belief. Legislators have clearly been paying only lip service to the sector's dire warnings that dermal fillers are a crisis waiting to happen.
“Most shockingly of all, the fact that there is no requirement for the actual surgeon involved to provide consent for the procedure makes a mockery of the entire process. It's business as usual in the Wild West and the message from the government is clear: roll up and feel free to have a stab."
In a statement, Sir Bruce Keogh said: “This is the beginning of a journey, not the end, but I am confident these changes will create a much safer and skilled cosmetic industry which should reassure both consumers and practitioners."
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