Dermal fillers are medical devices in the UK
BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b2923 (Published 21 July 2009) Cite this as: BMJ 2009;339:b2923Injectable 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 adopt FDA approval for dermal fillers. The Department of Health is in favour of self regulation by market forces because government regulation would be too costly for a problem that has minimal impact on the NHS. In 1968 the government passed a law controlling tattooing in the UK on the grounds of public health. The market for dermal fillers is much larger in terms of volume, and it must be regulated to reduce the risks of harm to the population.
Notes
Cite this as: BMJ 2009;339:b2923
Footnotes
Competing interests: None declared.