There is a dangerous trend afoot in the medical aesthetic space – counterfeit medical devices, including fake dermal fillers. Year after year, The Medicines and Healthcare products Regulatory Agency (MHRA) reflects on the successes of global action against the illegal trade in fake medicines and medical devices, consistently seizing large quantities from organised operators.1 It has also been estimated that 41.1% of practitioners have encountered counterfeits and 39.7% have experienced patients with adverse events from them.2
Counterfeiting affects many products, medical devices and cosmetic classifications, with a rise in UK imports of imitations of well-established dermal filler brands. The attraction for counterfeiters seems to stem from fillers’ status as the most in-demand cosmetic products within a global consumer-driven sector that has grown exponentially.
Counterfeiting in healthcare
Selling counterfeit pharmaceuticals is an attractive prospect for criminals, with high-profit margins, low chance of detection and prosecution and the ease with which they can deceive end users. In 2016, international trade in counterfeit pharmaceuticals reached US $4.4 billion, according to the Organisation for Economic Co-operation and Development (OECD).3
According to the World Health Organisation (WHO), ‘Counterfeit products may include those with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging’.4 WHO set up the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) in 2006 to raise national governments’ awareness of medicine and medical device counterfeiting, and to call for improvements to legislation.4 In 2010, WHO believed more than 8% of medical devices in circulation were counterfeit.5
Similarly, the trade in counterfeit pharmaceutical products in the EU has been increasing over recent years, according to the European Union Intellectual Property Office (EUIPO) and the European Union Agency for Law Enforcement Cooperation (Europol).6 In 2014, the European Regulatory Agencies intercepted counterfeit versions of Allergan’s dermal filler Juvéderm ULTRA 4. Galderma also reported that in 2017, it intercepted a number of counterfeit Restylane products from various locations destined for the UK.8
In 2020, medicines were the seventh most-seized products at the EU’s external border. They noted that criminals rely primarily on post and parcel services to ship counterfeit pharmaceutical products, which are mainly traded online.9
IBSA Derma warned as recently as January 2023 that it had received reports of counterfeit Profhilo circulating in Europe and Asia, affecting UK and Irish markets. It noted that the packaging was so similar to the genuine article as to be undetectable unless examined by the manufacturer.10
The forgers have clearly been honing their craft over the years, but law enforcement is taking the matter seriously. As part of ‘Operation Pangea’, coordinated globally by Interpol each year to tackle the illegal online sale of medicines and medical devices,11 the UK’s MHRA reported that more than 113,000 illegally operating websites and fake online pharmacies were shut down globally, 43 of which were in the UK.12
Similarly, this summer, the MHRA was involved in a joint operation with Greater Manchester Police where raids on commercial and residential premises in Bolton and Wigan seized unlicensed botulinum toxins and dermal filler products from an authorised beauty supplier. Three people were arrested for offences under human medicines legislation and money laundering.13
Parallel imports vs. counterfeit products
Market saturation within medical aesthetics, with actively competing healthcare and non-healthcare practitioners, a global online marketplace and consumer demand for cheap deals, has driven down prices for medical devices, particularly soft tissue fillers.14
Grey market products, though not illegal nor counterfeit, are those which are imported from another country without the permission of the intellectual property owner; thus, they carry batch numbers for products destined for another territory. Parallel imports pose a nonconsequential risk to patient safety because they are derived from unauthorised and non-tracked supply routes. End-to-end product traceability is lost, correct storage and handling cannot be guaranteed and products could be damaged or compromised in some way that affects efficacy or safety.15
The use of grey imports will leave you unsupported by the UK distributor or manufacturer subsidiary in the event of a problem, and it can inadvertently invalidate your medical indemnity insurance, leaving you high and dry in the event of a claim. More worryingly, counterfeit products can be easily mixed into this grey supply route unnoticed.16
For more information, go online to read our latest article on parallel imports.15
Beating the counterfeiters
The organised criminal gangs behind counterfeiting operations are getting smarter and will go to great lengths to copy product features, with the aim of making their fakes very difficult to distinguish from the real thing.17 Packaging is commonly cloned using the same ink colours, fonts, logos and paper type. Genuine tracking numbers are often copied and printed on the outside; these are usually replicated across a batch of fakes which helps manufacturers and authorities to uncover the deception.17
Many manufacturers have shared that there may be some tell-tale signs upon opening the packaging; package inserts may be different and syringes may appear more generic than the proprietary product, but only noticeably to those who are familiar with or have another to compare. Even needles can be bought from reputable sources for inclusion within fake products.
There are many manufacturers that have retaliated by introducing more sophisticated security features to their packaging to thwart counterfeiters and help practitioners spot a fake. Examples include adding holograms, embossed logos and shiny, glossy, lacquered or foiled elements within the packaging design that make replication difficult and cost-ineffective for forgers to target an individual brand.18 QR codes may be added for traceability via online apps.19 Many security measures are specific to the country of intended supply and managed within the final stages of the authorised supply chain. Anything sold within a country that does not have the required features will be either a parallel import or a counterfeit product.
Pharmaceutical companies have been using holograms on packaging for many years, but, despite their apparent sophistication, the counterfeiters soon learnt how to do it too. The same struggle occurs with currency. The Bank of England says that counterfeiting has substantially reduced since 2019 because of the introduction of more robust and counterfeit-resilient polymer banknotes and the withdrawal of older cotton-paper designs.18
Pharmaceutical companies are being drawn towards working with the same people responsible for developing enhanced security for banknotes and passports in the hope of winning the battle against filler fakers. The global security firm Giesecke+Devrient, for example, uses innovative, micro-optical technology with dynamic effects that are applied directly to packaging with high-precision embossing tools. The authenticity of a product can be verified quickly and easily across every part of the supply chain – from the brand owner through the various distribution channels to the end customer.19
The risks of counterfeit products
Counterfeit medical devices pose a significant risk to patient safety. Registered medical professionals will be held accountable in a medical hearing or tribunal by their individual professional, statutory and regulatory bodies (PSRBs) if they use them intentionally or unintentionally on a patient. Fitness to practise could be called into question, and insurance cover will not pay out if the worst happens. In the event of a claim on your policy, your insurer will request proof of the manufacturer and the batch code of the product used.15
In some cases, they may also require a purchase invoice.15 If it transpires that the product was not purchased from an authorised supplier, the claim can be repudiated and your policy may be cancelled because you, as the policyholder, have violated policy conditions in relation to product sourcing.15 Practitioners should mitigate their risk of purchasing fake injectables by using authorised stockists.
If you have already bought medical devices from outside approved channels and never had a problem, arguably, you were lucky; but please, do not do it again. You cannot guarantee you have a genuine or counterfeit product. It could be benign and ineffective, leaving the patient disappointed, but at the other end of the scale, the harm could be immeasurable.
Avoiding counterfeit products
The best way to guarantee genuine product authenticity and handling is to avoid grey imports where counterfeits may also lurk. Only purchase medical devices from authorised stockists and wholesale pharmacies approved by the manufacturer or their territory distributor, or buy directly to ensure traceability. Approved lists can usually be found on company websites, by contacting manufacturers and distributors directly or through their sales representatives.
If you choose to purchase from unauthorised wholesalers or other online sources, you will almost certainly be buying grey imports. You also significantly increase your chances of buying a counterfeit product. Often, there is little price difference between a genuine and a fake offering. Unauthorised suppliers may also lie about the source of their products to secure a sale – caveat emptor. You should also not leave the buying power in the hands of other clinic staff without first ensuring an adequate understanding of the dangers of cheaper deals or availability from unauthorised stockists.
Fighting back
If you suspect you have received a counterfeit medical device, you can report it directly to the brand owner (manufacturer subsidiary or territory distributor) and to the MHRA’s medical device compliance team (devices.compliance@mhra.gov.uk) or through the Yellow Card Scheme.22 When you submit a Yellow Card report online, you will receive a notification of submission which will contain your unique reference number. Your report will go into their database after a quality check, and you may be contacted for more information.22
Counterfeiting will not go away and will continue to pose a danger to the future of medical aesthetics without combined action to uphold supply chains, maintain traceability and control the safe use of medical devices. Maintain safe practices by always buying your medical devices, including dermal fillers, from authorised stockists.
Disclosure: Lorna Jackson was commissioned to provide a generic commentary on the subject of medical device counterfeiting by HA-Derma Ltd.
