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Government “paying lip service” to sector warnings

Government “paying lip service” to sector warnings

Patient safety high on industry agenda

 

Nearly a year after the publication of the Keogh report, the Government has responded to the report and its numerous recommendations. However, the reaction from the industry to the response has been less than enthusiastic, with many believing that the Government wasted an opportunity to implement safeguards into the market, particularly in relation to medical devices such as dermal fillers.

The Keogh report was launched following the scandal into PIP breast implants. Following its review of regulation in the cosmetic interventions sector, the group behind the report made 40 recommendations for the industry—in particular, highlighting dermal fillers as a cause for concern.

The Government backed the majority of the recommendations and has even begun to make some headway in their implementation. The Royal College of Surgeons has established a cosmetic surgery interspecialty committee and “work is underway”, new advertising guidelines on cosmetic interventions have been published, and the Health Education England is undertaking a “call for evidence” and held a round table to develop training and accreditation programmes.

In addition, there is recognition that recommendations concerning record-keeping are good practice or statutory in the medical field.

However, the two recommendations that many believed were key to reigning in “Wild West” cowboy practitioners—a registry of practitioners and making medical devices such as dermal fillers prescription only—were rejected by the Government.

The Government believes that a registry would be an unnecessary duplication as nurses, doctors and dentists would already be on their respective registers and that patient safety would be better served by improving clinical standards. However, there is no explanation as to how it expects non-healthcare professionals to be accredited and regulated, although it states that legislative options are still being explored.

While the Government says it supports “the principle that dermal fillers and other non-surgical cosmetic products should be prescription only”, it says it is hamstrung by EU law which defines the products as medical devices.

There are currently proposals to bring dermal fillers and the like under the EU framework for medical devices but this is unlikely to come into legal effect until 2015 at the earliest.

This may require manufacturers to seek authorisation for products before they can enter the EU market, but there is no indication that it will lead to dermal fillers being prescription only in the UK.

Mr Rajiv Grover, president of The British Association of Aesthetic Plastic Surgeons, says the association is appalled at the lack of action taken so far.

“This review…represents yet another thoroughly wasted opportunity to ensure patient safety. 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 directive 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. It’s business as usual in the Wild West and the message from Government is clear: roll up and feel free to have a stab,” Mr Grover says.

Sir Bruce Keogh, while welcoming the Government’s response to his eponymous report and noting the benefits that training and clear standards will bring, highlighted that “…this is the beginning of a journey, not the end.”

Author: bodylanguage

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