Weak Cosmetic Regulation Makes Guinea Pigs Out Of Brits, UK

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Dermatology
Article Date: 10 Aug 2007 - 3:00 PDT

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America's stringent rules on cosmetic fillers1 - injectable substances used to reduce wrinkles - mean companies are turning to Britain to test out new products2.

As reported in this month's Which? magazine, there are just seven cosmetic fillers that contain hyaluronic acid - found naturally in the skin - approved for use in the US, compared to around 65 in Britain3.

Every year 415,000 people undergo non-surgical cosmetic treatments such as fillers4. This boom has led Which? to call on the Government to strengthen the weak regulatory system that may allow potentially useless or even dangerous products through the net.

Isolagen - an example of weak regulation in practice

Despite Isolagen (a treatment that used patients' own cells to smooth out skin) being withdrawn in the US in 1999, it was still introduced to Britain in 2002. The company has since used information gathered in Britain to support its pending licence application in America.

Isolagen was not covered by any regulation in Britain at all meaning that, before it was withdrawn in 2006, the company was able to:

-- Describe the product as 'natural' despite patients' cells being stored in foetal calf serum.

-- Claim it had been cleared by the health regulator, even though Isolagen didn't fall under any British regulation.

-- Use experiences of British patients in its American literature, stating that 'retrospective study, clinical trials and treatment of patients in the UK' would improve the manufacturing process for America.

Jenny Driscoll, health campaigner, Which?, says:

"At the moment Britain is effectively a testing ground for cosmetic treatments. Consumers here do not benefit from the effective and stringent regulation systems that Americans have. New products are coming onto the market all the time and the regulation needs to keep up with the science.

"If the Department of Health doesn't step up and recognise the flaws in the system, it is leaving Brits potentially at risk."

Which? has been involved with an online support chat room, the Isolagen Action Group, where people affected by Isolagen can share experiences and problems. Other people affected can leave their story at www.which.co.uk/cosmetic and Which? can put them in contact with this action group if requested.

Further information

-- Most cosmetic fillers in the UK are covered by EU medical devices legislation.

-- This legislation is incredibly weak - allowing companies to self-certify or use independent testing laboratories.

-- Isolagen was not even covered by this regulation as using the skin's own cells meant that it was not a medical device.

-- Isolagen has now closed its European operation and has withdrawn from the British market leaving hundreds of people without the treatment they paid for.

1. Cosmetic fillers - also known as dermal fillers. Dermal fillers plump up the skin when injected in and therefore are used to smooth lines and make the skin appear younger.

2. American companies need test results as without evidence of a filler's effectiveness and safety they cannot apply for a licence from the Food and Drug Administration (FDA) for its use in America.

3. An estimate of the number of fillers containing hyaluronic acid (found naturally in the skin) by a consultant dermatologist who has clinics based in the UK and the US (taken from Which? magazine, August 2007).

4. Cosmetic Surgery Market Intelligence study from June 2006 published by Mintel International Group Limited.

http://www.which.co.uk