I welcome and laud the AJO-DO on the inception of an alert system ( AJODOAlert@gmail.com ) for reporting issues related to the safety of orthodontic products and treatment. It is interesting to realize how the clinicians of yesteryear faced certain problems with reference to the quality and the safety of the orthodontic materials. I share Dr Behrents’ views about the blessings bestowed on us and how technology has made orthodontic practice better than ever. There is enormous potential in every aspect of orthodontic science and practice, but not without a dark side. Gray-market and counterfeit dental and orthodontic products have appeared in the Indian market, and they represent a booming business.
In 2001 when I was a postgraduate student, I witnessed the use of orthodontic products that had undergone rigorous testing for human use. However, a serious concern was the high cost, which was not on par with the Indian economy. Most of the products were imported from the United States or Japan. By 2005, many orthodontists used legitimate products routinely in their practice. When the demand for the products increased and more practices emerged, a sudden shift happened. The Indian market was bombarded with products that were not legitimate. It became a booming business, and orthodontists could choose low-priced or high-priced products, depending on their situation. Low-priced products were preferred by orthodontists who practiced in suburban or rural areas, where paying capacity is low. Today, I see that gray-market products are prevalent, and it is disheartening that even high-profile practices use low-priced gray-market products. It is a dark side in Indian orthodontics.
In these times, whether the economy is tough or flexible, everyone is looking for a good deal. Although orthodontists may be tempted by dealers offering products at discounts of 10% to 50%, they should be aware that the old maxim most likely applies: if it seems too good to be true, it probably is. If the goods are gray market, there is a possibility that they might be counterfeit, or the formula or ingredients of the product, while bearing the same name, may not be the same as the legitimate products. In a global scenario, Christensen noted that aggressive competition in clinical practice and potential economic crises drive the orthodontic practice market with the differences in terms of quality of care. Cost seems to be valued more than quality, making the dental marketplace ripe with opportunities for the sale of less-than-optimal products.
Counterfeit materials that haven’t gone through proper protocols and testing (biocompatibility) could fail, resulting in cracks or leaching of material in a patient’s mouth. It has been reported that these products (orthodontic brackets and archwires) could leach significant amounts of lead. This is an alarming situation because lead poses a serious health hazard. It was a cringe-worthy moment when 600,000 counterfeit antimalarial tablets were intercepted by the Nigerian government in June 2013. Produced in and shipped from China, they bore an unexpected label: “Made in India.” Even the fakes were being faked. It was a new low.
Patients trust dentists to provide the best care possible, and dentists need to be able to trust that the dental materials they use perform as they are intended to. Elaborate safeguards are in place at different stages of the journey of a dental material from its conception to delivery to a dental office. However, some events in recent years have indicated that unscrupulous operators can subvert these safeguards and bring either illegal or counterfeit dental materials to market. When do we draw the line?