Orthodontics on sale: fixed appliances on E-commerce platforms

Introduction: The sale of orthodontic materials, considered as medical devices, is regulated in order to protect patients. The availability of orthodontic products on e-commerce platforms, however, may go unregulated and compromise patient safety. Objective: The present study aimed to investigate the sale of fixed orthodontic appliances on a local and global e-commerce platform. Materials and Methods: A cross-sectional analysis of orthodontic materials sold on Shopee and Amazon was conducted using a specific keyword search for brackets, arch wires and ligatures. After deleting duplicates and irrelevant search results, the top 50 products for each keyword search were analysed. Product name, the type of product, seller, cost, star rating, the number of reviews, the number of sales, shipping location and brand identification were recorded. Brand registration with a medical device regulatory authority was checked. Collected data were tabulated in Google (spread)sheet to derive descriptive statistics and frequency tables. Results: A total of 800 search results were screened. Three hundred and forty-eight relevant results were identified, approximately two-thirds of which originated from Shopee. Ligatures generated the highest search outcome in both Shopee (39%) and Amazon (80%). Fixed orthodontic materials sold on Shopee resulted in a larger number of reviews, higher star ratings and a lower cost per item compared to those supplied by Amazon. Products on Amazon were more likely to have brand identification (97%) compared to Shopee (5%). None of the identifiable brands on Shopee were registered with regulatory bodies, whereas eight products listed on Amazon were registered. A large portion of shipping locations originated from China for both e-commerce platforms. Conclusions: Orthodontic brackets, arch wires and ligatures are more readily available on Shopee compared to Amazon. The quality and safety of these products cannot be assured as the majority of the products were either not clearly labelled or their registration was not identified under the regulation of medical devices. (Aust Orthod J 2022; 38: 22 28. DOI: 10.21307/aoj-2022.003)


Introduction
E-commerce has become increasingly popular in the 21st century. As a result of advances in internet coverage and access, as well as an increasing use of smartphones, the number of digital buyers and online transactions increases every year. More recently, the coronavirus (COVID- 19) pandemic has also led to a shift in consumer behaviour to favour online shopping as an alternative to physical shopping 1 . In 2020, two billion people made purchases online and global retail sales reached more than 4.2 trillion U.S. dollars. 1 Various e-commerce platforms are available for potential buyers to search, compare and buy online items. The most visited online platform worldwide is Amazon, accounting for 3.68 billion visitors in 2020. 2 Malaysia has a high adoption rate with 88% of its population actively using the internet. 3 With a total population of around 32.7 million, Malaysia is an appealing market for e-commerce in Southeast Asia because of its fast-growing economy, advanced infrastructure and acceptance of digital technologies.

FIXED APPLIANCES ON E-COMMERCE PLATFORMS
In 2020, Shopee was listed as the most used Malaysian e-commerce market followed by Lazada. With around 47.3 million annual 'clicks', Shopee is also the leading online shopping platform across Southeast Asia. 4 A large variety of items may be purchased online and even medical devices can be acquired from these shopping platforms. 5,6 The term "medical device" refers to any product intended for therapeutic use. It applies to a range of products from contact lenses to heart pacemakers. Apple Watches beginning from series 4 which was launched in 2018, are wearable technology that is considered as a medical device due to included features to measure the wearer's heart rate, heart rhythm, and blood oxygen saturation. 7 It is a legal requirement, however, for these devices to be registered with local regulatory authorities to safeguard the health and safety of patients and consumers. The Medical Device Authority (MDA) and the Food and Drug Administration (FDA) are responsible for regulating the sale of medical devices in Malaysia and the United States of America, respectively. 8,9 Equivalent regulatory bodies in Australia and New Zealand are the Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE). 10,11 The level of control depends on the classification of the devices, which are based on potential associated risks to the user. The intended use, duration of use, and the part of the human body involved, are all factors influencing the risk assessment. 12 For instance, an orthodontic arch wire has been categorised by the MDA as a low to moderate risk (Class B) as it is considered relatively invasive (present within a body orifice) and intended for long term use. 12 Similar to other medical devices, the sale of orthodontic products on e-commerce platforms, is increasing. 6 A search on Lazada or Shopee will identify the availability of orthodontic products, ranging from personal home care products to orthodontic equipment and materials intended for professional use. It is not uncommon for these items to be distributed from overseas and sold at very cheap prices. Many items may have bypassed regulatory bodies and are sold freely over the internet, which potentially jeopardises the safety of the consumer. Unqualified individuals have also purchased orthodontic materials and equipment commonly known as 'fake braces' or 'fashion braces' to provide illegal treatment. 13 Hence, the present study aimed to investigate the sale of fixed ortho-dontic appliances on a local and global e-commerce platform.

Materials and methods
Ethical approval was granted by the Medical Ethics Committee, Faculty of Dentistry, Universiti Malaya (DF CD2113/0039(L)). This was a cross-sectional analysis of orthodontic material sold on the most common local e-commerce platform; Shopee, and the most common global platform; Amazon. Data collection was carried out from the 13th to 27th June 2021. To narrow the search, only the three main components of orthodontic fixed appliances were studied: brackets, arch wires, and ligatures. The following keywords were entered:

Results
After screening 800 search results, 348 relevant results were identified (Table I), with approximately two-thirds originating from Shopee. Ligatures ranked highest in the results from Shopee (39%) and Amazon (80%). Figure 1 indicates that the majority of the ligatures were of the conventional type. Similarly, more metal conventional brackets were offered on Shopee (77%) and Amazon (95%). There were three times more stainless steel arch wires offered on Shopee, than nickel-titanium wires.
Fixed orthodontic products available on Shopee generally received a greater number of reviews, higher star ratings, and cost less per item compared to those from Amazon. Figure 2 shows the average number of reviews posted for each orthodontic component category. Brackets and arch wires had a higher number of average reviews on Shopee (84 and 68 respectively) compared to Amazon (19 and 0 respectively).
Using a 5-star rating system, customers gave the highest average star rating of 4.87 (Shopee) and 4.36 (Amazon) for brackets (Fig. 3). There were no reviews or star ratings for arch wires catalogued on Amazon, as all three relevant search results lacked sales transactions.
Shopee's average price for orthodontic products was significantly less than Amazon (Fig. 4). The category with the greatest discrepancy was brackets, with a difference of RM73. There were only three relevant search results for arch wires in Amazon but they were excluded in the average cost comparison as the pricing displayed also included add-on items.
A comparison of the number of products with brand identification between the two e-commerce platforms is shown in (Fig. 5). Products on Amazon were more likely to have brand identification (97%) compared to Shopee (5%). None of the identifiable brands on Shopee were registered with regulatory bodies, whereas eight products on Amazon were registered.

Discussion
Conventionally, clinicians purchase orthodontic products directly from representatives of dental supply companies or via official supplier websites. Clinical products can now be purchased online from local or international suppliers through a variety of e-commerce platforms. A 2018 Goldman Sachs industry survey estimated that approximately 11% of the dental supply market has shifted to online transactions. 14 The Medical Device Act 2012 (Act 737) states that all suppliers in Malaysia must register medical devices in their inventory with the MDA. 15 When medical devices are imported, it becomes the responsibility of a local representative to ensure that the products are registered with local authorities. Those who fail to comply may be fined up to RM300,000 and or receive a jail term of not more than three years. 15 Dental professionals who knowingly purchase counterfeit dental material or equipment may be held accountable for any adverse patient effects. 16 Regulating online platforms can be challenging due to the sheer number of sellers and products. A study of Tmall, a leading e-commerce platform in China, revealed the widespread sale of medical devices, specifically dementia-related health products on its website. 5 Similarly, the present study found orthodontic products available on Shopee and Amazon sites. It was also found that more sellers were promoting   orthodontic products, specifically, components of fixed appliance systems on Shopee compared to Amazon. This could be due to the implementation of the Professional Health Care Program by Amazon in which products for professional or prescription use may only be sold by sellers participating in the program and to appropriately licensed healthcare customers who have Amazon Business accounts. 17 This undoubtedly influenced the study's findings, as a personal account was used to simulate a public consumer when searching through Amazon's catalogue. Although fewer relevant search results were generated from Amazon compared to Shopee, it was evident that orthodontic products were being sold despite efforts to regulate their sale. On Shopee, unregistered medical devices are classified as prohibited items due to infringement of local regulations. Sellers with violations risk having their listings removed, being issued penalty points, or the termination of their accounts with the possibility of legal action. 18 It is clear that despite such policies, prohibited items are still being sold on the platform.
The leading e-commerce platform in Australia, eBay, adopts a similar approach to Shopee in which penalties and suspensions are given to sellers who promote medical devices that do not have a valid Australian Register of Therapeutic Goods (ARTG) number. 19,20 Orthodontic ligatures appeared to be the highestselling item on both platforms, with arch wires and brackets sold on Shopee not far behind. Keyword searches on Amazon yielded lower results for brackets and search results were almost non-existent for arch wires. The majority of ligatures sold were the conventional elastomeric type (95%) which were also found to be cheaper than other designs. The other designs included colourful Kitty, Mickey or Flowershaped ligatures which are commonly associated with 'fake braces' or 'fashion braces', as the emphasis is placed on appearance rather than function and the ability to maintain adequate oral hygiene. Products on Shopee were more likely to have no identifiable brand name in the product description or on the images provided. It is a legal requirement for medical devices to have appropriate labelling and packaging to convey safety and performance-related information to consumers. 21 Furthermore, only eight products from Amazon were identified as registered with the FDA, whereas none of the products found on Shopee were registered with the MDA. Products that are registered should bear the registration number on their packaging. 21 Both the MDA and FDA have compiled a list of registered medical devices readily available to the public online, in order to improve transparency and to encourage the reporting of unregistered products.
The orthodontic items listed online were relatively cheap and most were shipped directly from China.
With roughly 50% of global e-commerce transactions, China had the largest e-commerce market throughout 2021. 22 This is concerning because it was reported in 2015 that, at least two out of five products sold online in China, were counterfeit or of poor quality. 23 Without appropriate item registration, it is unclear if the products are safe to use. A local study identified increased metal ion release from orthodontic brackets bought from online suppliers. 24 The brackets are also presented with rough surfaces, making them prone to corrosion and breakage. 25 Two deaths in Thailand have been linked to the use of 'fake braces', which are commonly sold online. 26 Dentists and the public in the United Kingdom have been advised about buying dental equipment using the internet after the Medicines and Healthcare products Regulatory Agency (MHRA) enforcement officers raided and seized several potentially dangerous counterfeit dental instruments. 27 An additional potential hazard is the existence of online grey market products. This refers to registered products sold by unauthorised distributors who have obtained the items through the black market. Hence, there is no guarantee that the products have been stored or transported correctly, according to the manufacturer's guidelines, and therefore potentially compromise product efficacy and patient safety. 28 Overall, most products in the present study received positive ratings of above three stars, with one ligature product from Amazon receiving over 1245 reviews. The impression was that the products were being purchased and were viewed favourably. However, it is of concern that the results of the present study may be affected by fake product reviews. Fake reviews can be bought in private internet groups such as Facebook, to significantly improve star ratings. A recent study by He et al. found that low-quality products were more likely to manipulate star ratings to deceive consumers. 29

FIXED APPLIANCES ON E-COMMERCE PLATFORMS
The findings of the present study suggest that the enforcement of medical device regulations on e-commerce platforms is still considered poor, especially in Malaysia. It is important to raise public awareness about the importance of verifying with regulatory agencies before purchasing medical products on e-commerce platforms. That the search for orthodontic materials was limited to brackets, arch wires, and elastomeric ligatures provides an additional limitation of the present study. Furthermore, searches were conducted on only two online platforms, Shopee and Amazon, hence the full extent of orthodontic material being sold on e-commerce platforms is unknown. Moreover, some data extrapolated in this study may be vulnerable to fake reviews and transactions.

Conclusions
From a consumer perspective, Shopee has a larger selection of orthodontic brackets, arch wires and ligatures compared to Amazon. A large number of the products were either not clearly labelled or were not registered with appropriate regulatory organisations for medical devices. Consumers are advised to avoid online orthodontic purchasing due to the questionable quality and safety of products that have not been registered.