UK becomes testing ground for dermal fillers
minefield as Britons unwittingly receive unlicensed dermal filler
procedures not available in the US, according to Independent
watchdog, Which? Magazine.
Due to weak legislation in the largely unregulated UK cosmetic filler market, companies are now thought to be using UK consumers to test injectable anti-wrinkle treatments that have not made it onto the more strictly regulated US market. The level of regulation regarding this booming market has been called into question following recent legal action threatened by a group of UK consumers regarding a dermal filler, Isolagen, with patients paying thousands of pounds for the treatment, that was withdrawn from the US market in 2002. Isolagen, a treatment that uses patient's own skin to smooth out skin, has since been withdrawn from the UK market, a relatively immature market for dermal fillers, with consultant dermatologist Dr Nick Lowe telling Which? that some fillers can cause bumps that need to be surgically removed. "Fillers are released in Europe without sufficient scrutiny, information and education on the best way to deliver them. In this country we learn by experience - we now know which fillers are good in lips and which ones produce bumps in lips". "Whereas the FDA produces stringent guidelines on where they should be used," he continued. The trend for dermal filler injections, such as Botox, is gaining in popularity in the UK. Over 400,000 UK consumers are opting for the non-surgical procedures each year, despite companies being able to self-certify or use independent testing laboratories to certify products under EU legislation. The UK has around 65 unmonitored treatments doing the rounds, in comparison to the US, which only has seven FDA approved dermal filler applications. An issue that, according to Which?, has the government deliberating over ways in which to further police the growing number of potentially dangerous products. Worrying statements have arisen by companies such as Isolagen, who are using statements in its American literature such as 'retrospective study, clinical trials and treatment of patients in the UK would improve the manufacturing process for America' according to Which? According to a spokeswoman from the UK's medicines and medical devices watchdog, MHRA, the EC has produced a scoping paper to look at the issue further, with the commission currently 'under discussion to arrive at a UK position on how the products should be regulated'. However, Which? has voiced concerns that this still does not fall in line with the strict US attitude that sees FDA experts checking all products match up with manufacturers claims.