The recent PIP breast implant furore has resulted in questions not just about the regulation of cosmetic surgical procedures but also about regulation of injectable intradermal fillers. Injection of intradermal fillers is one of the most popular cosmetic procedures in the UK with hundreds of thousands of procedures performed annually, compared to less than 10,000 breast augmentation procedures.

A recent article in the Times1 states that there are160 injectable fillers certified for sale in the UK and that they can be purchased and administered by anyone, including those with no medical training. The BAD is concerned about both the safety of some of these products and also the absence of direct regulation of who is allowed to inject them. Significant changes are required in order to safeguard patients and the public.

Intradermal fillers are classified in the UK as a medical device; the requirements to obtain a CE mark to allow certification for sale are minimal. This puts the public at unnecessary risk. Intradermal fillers are not “inert” and have been shown to cause physiologic changes in the deeper layers of the skin. Debilitating long-term reactions to various products are well documented in the medical literature. In order to improve patient safety, adequate safety and efficacy data should be a requirement for any intradermal filler prior to entry into the market.

Injection of intradermal fillers is a medical procedure, albeit for a cosmetic indication. The trivialisation of these medical procedures by absence of direct regulation of who is allowed to administer them is hazardous. Facial anatomy is complex and includes elaborate networks of nerves, blood vessels and other important structures; any injection using a hypodermic needle can potentially cause serious or irreversible complications. Those injecting should have the breadth of medical knowledge to not only safely administer the intradermal filler, but also to understand the potential complications with the ability to treat them appropriately should they arise. Absence of this specialist knowledge may unduly burden the NHS.

As a consequence the BAD would call on the government (via the offices of the Department of Health and the MHRA) to:

1) Reclassify all injectable intradermal fillers as drugs/medicines OR significantly increase the requirement for evidence-based safety and efficacy data prior to their approval as medical devices.

2) Ensure that intradermal fillers may only be prescribed by medical practitioners (such as dermatologists and plastic surgeons) who have not only been trained in their indication and administration but have the breadth of knowledge to understand the evidence-base for their use. In addition, prescribers should have the ability to recognise and understand the pathomechanisms of any complications which might arise in order to treat them appropriately. This is particularly important in the light of potential financial implications to the NHS if private practitioners are unable to recognise and treat complications which arise in their own patients.

3) Ensure that patients or “customers” seeking these procedures receive appropriate counselling regarding the risks and benefits of the procedure by a practitioner who has the specialist professional knowledge to understand the potential benefits, complications and treatments thereof, which are based on scientific evidence.

4) Recognise that injectable treatments are a cosmetic application of a medical procedure. As such, a core foundation of medical knowledge is required to administer them appropriately and safely.

5) Recognise that as medical procedures, excessive advertising and financial incentivisation (both for the patient and the practitioner) is inappropriate.

6) Produce guidelines reflecting these changes which specify exactly: who can prescribe intradermal fillers; who can administer intradermal filler procedures and; what levels of appropriate professional training are required.

7) To make clear both to the cosmetic industry and the public what these changes mean and why they are important to patient safety.

This statement has been prepared by the British Association of Dermatologists in conjunction with its affiliated specialist group, the British Cosmetic Dermatology Group, and is endorsed by the British Academy of Cosmetic Practice.