Orthodontics on sale: fixed appliances on E-commerce platforms

Abstract

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.

‘Fake Braces’: A Content Analysis of Instagram Posts by Unlicensed Providers

“…The cost of services was a fraction of costs quoted by legal practitioners with further reductions offered with promotions and value-added purchases. Cheap orthodontic materials are widely available on e-commerce platforms, with products almost universally not registered with local regulatory bodies (22). Various complications such as caries, gum disease, allergic reactions, unwanted tooth movements and even death, have been linked to fake braces (6).…”

Challenges in curbing illegal orthodontics: A qualitative study on dental enforcement officers in Malaysia

“…None of these products or equipment were registered with the Medical Device Authority (MDA) of Malaysia, raising concerns about their quality, safety, and authenticity. 26 These items were often inexpensive and primarily sold by overseas sellers, particularly from China, making enforcement by the MDA extremely difficult and beyond the scope of the Oral Health Legislation and Enforcement Section. This is not an isolated issue limited to Malaysia, as many e-commerce platforms have largely evaded accountability for the sale of counterfeit or defective products, although recent lawsuits in European countries have called for increased product liability.…”