The shocking tendency to ' make ' Injectables

Raise your hand if you found yourself at your local B&Q on a bank holiday weekend, buying up half of the store for a DIY project on the spare bedroom...

As a nation, we think nothing of embarking on such do-it-yourself household projects in the vain hope that the money we will save on not employing a qualified builder, decorator, electrician, plumber etc. will more than make up for the less than professional finish to the job in hand!

Now, hands up those of you who would also be prepared to shun the expert advice of a cosmetic practitioner and instead opt to self-administer unknown cosmetic injectables...

Hopefully no-one raised their hands this time; but unfortunately with the global growth and reach of the Internet and recent economic hardships, the 'DIY cosmetic jab' is becoming easier and easier to obtain. Online retailers are springing up overnight to satisfy the growing demand in the USA and more recently the UK, for cheaper alternatives to in-clinic injectable treatments, which people seem more than happy to self-administer with instructions not dissimilar to those of a flat-packed wardrobe!

We investigate this worrying development.

Global Recession Hits Beauty Spend

The current economic collapse has come as a bit of a shock to the British and American public and led to some swift belt tightening and bargain hunting, with fewer of us making large purchases or spending as freely on luxuries, and foreign holidays.

In the boom years of the early 'noughties' we were all happy to 'splash the cash' and splurge on a bit of retail therapy and hard earned pampering, even if it was courtesy of Mr VisaR and Mrs MastercardR.

With more and more aesthetic clinics opening the length and breadth of the country in the last decade, and minimally invasive, non-surgical treatments, not only becoming more widely available, but more socially acceptable and affordable, we all rushed out to be at the front of the queue to look ten years younger, wallets waving in the air.

Then with the overnight collapse of many high street banks, the rise in unemployment figures, the drop in interest rates and the drying up of credit facilities, money has suddenly become a much more precious commodity to many households than it was before, and every penny is now being accounted for.

Needless to say, the UK aesthetic and beauty industries seem to be weathering the economic storm pretty well so far, despite the lack of available credit for many people. This appears to be primarily due to the effect of the 'baby-boomers' who are now coming of age, (currently aged 45 - 63), and their continued availability of disposable income, plus a desire to retain their careers and thus their youth.

However, surgical procedures, which do require a larger cash investment (often previously financed by loans), have seen a slump in demand according to some experts; with the British Association of Aesthetic Plastic Surgeons (BAAPS) admitting earlier this year that the industry is in the middle of a "slowdown" and that this year could see the first decline in cosmetic surgery audit figures.

Conversely, The Harley Medical Group, the UK's largest cosmetic surgery group with an annual turnover of ￡35million, recently reported a year on year growth to the end of June 2009 of 4% and has opened 6 more clinic locations in that time. Chairman, Mel Braham was quoted as saying; "Despite the recession we're seeing increases in surgical and non-surgical procedures at our existing clinics and that's why we've committed to an expansion programme".

Although a report published in May 2009 by analysts Research and Markets did note that the UK cosmetic surgery market had experienced only a modest growth in 2008, which was a change from its previously remarkable year-on-year increases between 2004 and 2007.

Despite these differing reports, many other industry participants are reporting a dramatic fall in the number of operations such as breast augmentation and cosmetic rhinoplasty in women under 30, who are typically being refused credit and have no other financial means for payment. This also appears to be the case with finance options previously provided by clinics for courses of non-surgical treatments such as laser hair removal, laser lipolysis and on-going treatment programmes.

Yet where the financial means dries up, the desire to look good and youthful (often at any cost!) still remains and unfortunately there seems to be a growing trend in America in the sale and use of Do-It-Yourself kits for cosmetic injectables such as dermal fillers and botulinum toxins, as well as high strength chemical peels and fat dissolving (injection lipolysis) kits.

This worrying consequence of an economic downturn is now lapping at the shores of Britain, due in the main to the ease with which cheap, copy-cat or generic products, often hailing from China, can be bought via the Internet (without prescription) and shipped around the world, escaping the watchful eyes of customs authorities.

We covered the growing Chinese industry for hyaluronic acid filler based products in last month's feature article - China- Country of Cosmetic Filler Counterfeiters or Genuine Commerce? - and it is this availability of cheap, generic products, along with botulinum toxins produced by the same Chinese manufacturers that is fuelling the growth in online sales direct to a price conscious audience who are convinced that 'eggs is eggs' when it comes to the contents of a syringe.

DIY Kits Available Online

We think nothing of turning to Google(TM), or other popular search engines, every time we want to find the answer to a burning question or source a product or local service, and it would seem that the availability of cosmetic injectables, direct to your door, is just as easy to find.

A quick 'Buy Botox', 'Buy Cosmetic Fillers' and 'Buy Dermal Fillers' search revealed a ready source of websites happy to supply substitute, generic, clone, copy-cat or even counterfeit products claiming to be just the same as well known brands, at a fraction of the cost of visiting your local clinic and sourcing the genuine products.

Prices start from around $150 (currently approx. ￡90) for a complete DIY kit which includes needles, saline for toxin reconstitution, 'helpful' directions, including a facial map of injection sites, and a 100 unit vial of botulinum toxin type A, or around $130 (approx. ￡80) for a 1ml syringe of hyaluronic acid.

Both of these types of kits are happily offered for shipping to the USA, Canada and the United Kingdom with claims of 100% success rate at getting the packages through customs and to the end purchaser. Such statements in themselves highlight the shady nature of this e-commerce activity.

One website, run by a woman from Dallas, Texas, claims that having visited a clinic three times she wondered if she could indeed do the procedure herself as it seemed so quick and painless. Plus, she reasoned that if she could do it herself, she wouldn't have to pay the high price charged at the clinic. From there she sourced the products through the clinic where she worked and set about offering the products to her friends and family for their own home-use. She now claims to be proud to be offering a method to obtain the same products and results for home-use, as is available where she works.

In fact so confident is she in her ability to 'help' individuals to 'do-it-yourself' that she has various videos on You Tube(TM) demonstrating just how to use the botulinum toxin kits that she sells and how to give yourself a lip augmentation using hyaluronic acid. Such videos, widely distributed by this video hosting site, are considered by them to be within their Terms of Service and Community Guidelines so do not attract enforcement measures, despite being undesirable and downright irresponsible.

More worrying perhaps is the fact that some of these sites are also selling PMMA (polymethyl and methacrylate) based dermal fillers direct to the public. This is a permanent filler substance more commonly known to practitioners as an ingredient in the FDA approved ArtefillR branded product.

As this substance is not metabolised by the body, as ultimately seen with neurotoxins and hyaluronic acids, the potential for serious adverse reactions and complications from self-administration is heightened yet further in non-medical hands and any results will of course be 'permanent'. Aside from the general risks of self-injection without medical knowledge, the DIY use of such substances could well result in problems such as product migration, infiltration into other tissues, such as vascular areas - causing blockage of arteries resulting in tissue necrosis, granulomas (small lump formation) and allergic reactions.

Even in the hands of professional clinicians, such permanent products are often felt to be less desirable treatment options as they can cause lasting complications, depending on injection techniques and individual tissue reactions. The British Association of Aesthetic Plastic Surgeons (BAAPS) reported in June of this year that 1 in 4 of its members had treated patients who needed surgery due to complications with permanent fillers in the past year.

Additionally, it was noted during our investigations that some of the online retailers offering hyaluronic acid based dermal fillers direct to the public are supplying them with XylocaineR, which is a 1% mix of lidocaine, a local anaesthetic for pain relief and epinephrine, also know as adrenaline, which restricts blood flow to the area injected to reduce bruising.

According to the online retailer, this prescription-only-medicine (both in the USA and the UK), can be mixed together with the filler substance using a syringe exchanger that they supply, as a means of reducing the discomfort from self-injecting into the lips or deep folds, such as the naso-labial region.

A standard 20ml bottle of XylocaineR is supplied, without the requirement to present a prescription, with instructions to mix 1ml of the XylocaineR with the purchased 1.1ml or 2.1ml syringe of hyaluronic acid filler.

Many of the large, mainstream brands available in the UK, such as JuvedermR ULTRA and RestylaneR now have products which come with a 0.3% lidocaine composition for increased patient comfort and recently it was approved by the U.S. FDA that practitioners may mix Radiesse(TM) (a non-HA filler) with 2% lidocaine using a syringe exchanger.

The manufacturers of XylocaineR note that special care should be taken in the use of this product as it must not be injected intravenously, i.e. into a vein or blood vessel. When injecting a product, medical professionals will (where possible) perform aspiration when using lignocaine directly i.e. for lip blocks, by pulling back on the syringe after inserting the needle to check for blood flow which would indicate entrance into a vascular area, to make sure that they were not injecting into a blood vessel. Non-medics, self-injecting would not be aware of this practice, or the risks involved with this product and could cause increases in heart rate if incorrectly injecting XylocaineR. The risk of overdose is minimal due to the quantities involved, but clearly harm could be done and should only be placed in the hands of medics.

Dr. David Eccleston, Medical Director of MediZen Ltd and medical advisor to The Consulting Room(TM) comments;

''When I read that people were actually considering ordering and using such products off the Internet, I had to read it twice more before I believed it. Of all the drugs used in medicine, lidocaine and adrenaline are two of the drugs doctors must use only with accurate dosing, proper patient counselling and past medical history all being taken into account. In these circumstances, such medications are safe and useful in cosmetic treatments in the hands of an expert. No-one should be given such drugs outside a registered HCC approved clinic or hospital, GP or dental surgery unless in an emergency situation. Using such products outside of this could easily lead to a fatality.''

Snake Oil?

The sale of ANY dermal filler or botulinum toxin to the general public is very worrying in itself, however it becomes even more concerning to think that often potential purchasers will be taking these websites on face value and trusting that what they supply is indeed what they say it is.

It is impossible to tell with the naked eye just what is contained within the supplied syringes or vials, which the online retailers market as simply generic 'alternative' products to the major brands. It may well be that genuine ingredients, (albeit unproven ones in terms of clinical safety data), are contained within the syringes and vials supplied, but they could also contain other, more unconventional substances or additives, simply labelled up as a pure neurotoxin or hyaluronic acid, to which a purchaser would be none the wiser.

Additionally, in the case of botulinum toxins, which are biological products, there exists a quality control route in the UK whereby the licensed brands, such as BotoxR, VistabelR, AzzalureR, XeominR & DysportR are checked to verify that the products actually are what they say they are. The National Institute for Biological Standards & Control (www.nibsc.ac.uk), part of the Health Protection Agency, checks each batch of toxin produced by a manufacturer before it is allowed into the supply chain. Tests are done on random vials within a batch to check for the calibration, i.e. that the actual number of units in a vial matches what is quoted on its packaging, as well as the potency of the toxin within. Certain benchmarks or tolerances are established for these tests, and should anything have gone wrong during production which means that quality control levels are not met; an entire batch would have to be destroyed in the interest of patient safety, before it ever got into the hands of practitioners.

As you can imagine, such rigorous checking does not exist in other less developed countries and certainly not in the case of the unapproved or unlicensed botulinum toxins now flooding the global market from Chinese sources. It is therefore impossible to verify the unit levels of the vials supplied by online retailers, or their potency, against what they print on the labels, assuming indeed that the vials contain botulinum toxin type A in the first place.

The use of cheap, unapproved botulinum toxins is not something just seen with the non-medical DIY injector.

As recently as 2006, a U.S. doctor from Florida was sentenced to 3 years in prison and had his medical licence withdrawn for injecting himself, his girlfriend and two friends with an unapproved botulinum toxin that was manufactured for research purposes only, i.e. not for human use.

In an effort to procure cheap, generic toxin, the doctor in question, Bach McComb, ended up with a product with a potency much higher than is found in approved products for cosmetic use; thus when he prepared it he didn't dilute it sufficiently prior to injection and all patients, including himself, were hospitalised for poisoning by botulism which causes a paralyzing and life threatening effect. All recovered, but many maintained debilitating side effects for a number of years.

Mr. McComb was given a more lenient jail sentence than the 20 years he originally faced as he too was a victim of his own crime and pleaded guilty to all counts.

The husband and wife team who fronted the company, based in Arizona, which sold Bach McComb and more than 200 doctors around the USA, the research grade toxin, knowing full well that it was likely to be used to treat patients cosmetically, were eventually sentenced to 6 and 9 years in prison and made to pay damages of over $690,000. It was quoted by the FDA investigating authorities that in total they had managed to sell over 3,000 vials of their research toxin via sales conferences.

Several other U.S. doctors have since been fined and imprisoned when they have been found to be using this unapproved, research quality toxin on unsuspecting patients.

So, if a Doctor can make that kind of mistake or bad judgement call, it would be extremely easy for a lay person to think they're getting a good, value for money deal when buying toxin products over the Internet. The possibilities for overdose and serious harm are clearly evident, even in the hands of medically trained professionals who think they know what they're doing with the drugs.

Industry Fights Back

Despite this risk it would seem, from the number of companies advertising and supplying kits, that many consumers are happy to purchase these toxin and dermal filler products and are ready and willing to self-inject.

Nigel Mercer, the President of BAAPS, recently purchased a dermal filler kit over the Internet to see just how easily available these DIY solutions are to the general public. It arrived in a padded envelope with a pre-filled, unmarked syringe and a diagram with instructions on where to inject the product.

Amazed at how easy his purchase had been he said; "The public must understand that injecting fillers requires an expert knowledge of facial anatomy and a degree of dexterity that cannot be done by just anyone. A filler injected into the wrong part of the face can lead to lumps, facial disfigurement, or even cause a stroke."

Similarly, consumer champions, Which?, also investigated this growing trend earlier in the year and were able to buy a 'Botox Kit' via the auction website eBay from a woman based in Texas, (no doubt the same woman we came across in our investigations).

Sarah Kidner, Editor, Which? Computing said at the time; "We were appalled that we were able to buy a DIY Botox kit so easily and we are concerned that the internet is becoming a marketplace for cut-price cosmetic treatments."

Despite botulinum toxin being a prescription medicine in the UK, the medicines regulator, the MHRA are unable to stop anyone from shipping such products to the UK as online retail companies, operating in the USA, fall outside of its jurisdiction. The reliance is therefore on such packages being stopped and seized at UK borders by our Customs teams.

As you can imagine, many believe that this state of affairs is far from ideal and needs to be addressed by global governments, to crack down on the manufacture and shipment of unapproved, untested and potentially harmful pharmaceuticals. As always, it seems we will need a lot more people to get hurt, before action is taken.

Copyright c 2009 The Consulting Room(TM).

Lorna Jackson is Editor of The Consulting Room? http://www.consultingroom.com, the UK's largest aesthetic website providing clear and unbiased information to the public on a wide range of surgical and non-surgical cosmetic treatments, combined with a directory of UK & Ireland based clinics and surgeons. The Consulting Room? Shop http://www.consultingroomshop.com, is the first aesthetic online store backed by FACT not FICTION and offers a simple and secure online shopping experience for all the latest in at-home, clinically proven skincare, suncare, post cosmetic surgery after care, laser hair removal and hair growth devices, slimming garments and a wide range of other aesthetic products.