Published 21 July 2009, doi:10.1136/bmj.b2923
Cite this as: BMJ 2009;339:b2923

Letters

Medical device industry

Dermal fillers are medical devices in the UK

The first 150 words of the full text of this article appear below.

Injectable dermal fillers are registered as devices rather than prescribable medicines in the United Kingdom, requiring only CE marking (which relates to production standards, not efficacy) for release on to the market.¹ In the United States they have to be approved by the Food and Drugs Administration (FDA) as medicines. Therefore over 140 injectable fillers are available in the UK compared with six in the US.

The lack of UK regulation means that dermal fillers need not be prescribed by a doctor and that anyone can inject them. As a consequence, members of the British Association of Aesthetic Plastic Surgeons (BAAPS) have seen an alarming number of patients with clinically significant harm from injection of fillers into the wrong site. Semi-permanent and permanent relate to the chemical constituents of fillers, not to the type of correction produced, as the public often thinks.

Most BAAPS members (96%) want the government to . . . [Full text of this article]

¹ British Association of Aesthetic Plastic Surgeons (BAAPS), Bristol BS1 4LF

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Dermal fillers, botulinum & lasers are potent treatments with the potential for serious adverse effects. They should remain in the medical domain

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