Unlicensed products – fake fillers and faux-tox

www.securingindustry.com

Aesthetic treatments continue to be increasingly popular, but along with this the number of counterfeit facial aesthetic products available is increasing. Last week discoveries of counterfeit botulinum toxin being supplied to clinics in the US brought up once again the problem of fake facial aesthetic products being available to the public. Although in this case the products came through an unlicensed supplier, these potentially dangerous materials are normally found online, often for what seems like a remarkably low price, but what is in the packaging will not be worth the money paid out. An online search for containers of botox and dermal fillers soon came up with a range of results, the majority being from the manufacturers themselves or via practitioners. However products that could be mailed to a home address with ‘diy’ instructions on how to use them were also available. Large, reputable sites such as Ebay and Amazon had no listings, but searches in European, Chinese and US sites found providers for botox and fillers with no questions asked, only payment. The volume of counterfeit injectable aesthetics products over last 10 years is enormous – $75bn worldwide of fake pharmaceuticals is estimated to have been sold.

So what is in counterfeit facial aesthetic products and what are the potential effects? The simple answer is that it is very hard to tell as counterfeit products could be made anywhere with anything. Even if the correct medications are present the dosage is very unlikely to be accurate. The result of this is that the effects of using unregulated products is also very hard to tell, but infection is much more likely as non-sterile material and/or needles are pretty much a certainty. And as it is impossible to provide a correct dosage, the effects are pure guesswork with a real possibility of an overdose.

How can black market products be spotted? The most obvious clue is a price for products or treatments that is consistently very low compared to recognised providers. There may be legitimate offers but these would be noted as such and the prices for other treatments would be average amongst reputable practitioners. Botox that does not need a prescription, according to the provider, should also be treated with suspicion. Botulinum toxin is a ‘prescription only medicine’, although large clinics may order it in bulk legally using a single prescription. In 2004 the US Food and Drugs Agency jailed several people, including some doctors, for using botox vials which were for research use but passed off as Allergan Botox Cosmetic. The vials had the markings for the manufacturer Allergan but also “For Research Purposes Only. Not For Human Use” stamped on them. Fillers and peels can be ordered through companies although the Keogh report reviewing the Regulation of Cosmetic Interventions published in 2014 recommended that fillers should also be prescription only medicines, but this recommendation was rejected by the government.

There have been reports of dermal filler materials being drawn from large containers into syringes for use and these would be counterfeit products. All legitimate fillers are packaged in small syringes with amounts varying from 0.55ml to 1.8ml which are produced in an aseptic (surgically clean) laboratory environment. Sometimes small amounts may be placed in sterile syringe via a sterile connector or mixed with anaesthetic solution (with Radiesse and Sculptura this is commonly done) but usually fillers are used in the original packaging.

Names of facial aesthetic products are multiple. For botulinum toxin the major manufacturers are Botox Cosmetic (Allergan), Xeomin, Bocouture (both Mertz), Dysport (Ipsen) and Azzalure (Galderma). Myoblock is a very rarely used type of botulinum toxin manufactured by Solstice. Fillers are manufactured by a number of companies and the best known are Restylane, Juvederm, Teosyal, Radiesse and Sculptura. As there are over 200 fillers that have been awarded the CE mark, some fillers legitimately manufactured may not be known to even the most experienced practitioners. This makes fillers harder to spot as counterfeit, but the treatment should always be carried out by a qualified practitioner who will know about the product they recommend and would be able to provide reassurance that could be checked online. There are a huge range of creams and lotions on the market, including homeopathic ones that have not gone through any recognised testing procedure. Recognised, established websites are useful for reviews of their effectiveness but advertising claims are often pitched at an aspiration instead of a reality. My personal preference is for SkinTech products, but ranges such as the Obagi and Glo lines are also very popular. I have also commented on news stories about creams on my Facebook site.

Creams containing ingredients such as alpha hydroxyl acids, beta hydroxyl acids, hyaluronic acid can be found in shops and online. There is a wide variety of manufacturers and any unknown cream claiming remarkable results should be viewed sceptically. There are no clinically recognised creams with botulinum toxin on the market but clinical trials are taking place. ‘Botox creams’ may prove to be beneficial for hyperhidrosis (excessive sweating) in the future, but are very unlikely to be effective for wrinkle reduction. The creams incorporating hyaluronic acid, the main ingredient in the most popular dermal fillers, can be bought in shops or online. It is worth noting that the hyaluronic acid in a cream is no more than a good moisturiser which will only help with very fine lines as it cannot penetrate through the skin.

Counterfeit products are normally provided by unqualified practitioners, frequently working without any legal insurance. All treatment should be in an area where cross-infection can be controlled with gloves and antiseptic skin-wipes are used. Consent forms should be used and qualifications visible. Unfortunately this degree of training is part of the cost of the treatments, but the cheap alternative can turn out to be much more expensive and damaging.

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