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    The hidden danger of the gray market

    Why buying unauthorized, cheap dental products can be more expensive than you could dream.

    Imagine you're an average patient who's just gone in for a fairly standard procedure—maybe you got a new crown, or a small bridge. Your dentist placed a crown made of zirconia instead of gold, and you're happy about it—it's much cheaper than a gold restoration would have been, and your dentist explained how strong it is and how long it will last. Plus, it looks great.

    You head home, and in the next few days, you start to get headaches. You feel run down, and you're not really sure what the problem is. You wonder if you could be having a reaction to something you ate, or something you were exposed to. You trace back the last few days to see if anything had changed in your diet or activities. Nothing comes to mind, however, except … you just got a crown made of zirconia. And you wonder:

    What's in my mouth?

    This story might sound far-fetched, but in fact the possibility for it to happen might be more common than you think, at least according to many of the sources Digital Esthetics spoke to for this article. The reason it's a possibility is because of materials, equipment and dental supplies that enter the United States by skirting around regulatory, market and governmental standards. This shadowy availability of goods outside the normal modes of commerce describe something called the gray market. And all-too-often, dentists and dental technicians can be seduced by the low prices and false promises of the gray market.

    Related: 4 things to know about gray market products

    What IS the gray market?

    The gray market can be tough to accurately define, but, generally, in a dental context, it refers to any dental goods, products, supplies or equipment that somehow avoid the regulatory process. "When we talk about the gray market, we are talking about products sold through an unsecured supply chain," explains Simon Hearne, Vice President of International Business, 3M Oral Care. "There are three main categories these fall into:

    "1. Products that are diverted from an authorized channel: These products often don’t comply with local laws and may have compromised quality due to improper handling or storage conditions;

    "2. Repackaged or relabeled products: This practice often happens with products nearing the end of their shelf life. Gray market dealers may change or remove the expiration date and repackage the product in order to sell it to unsuspecting buyers. In some cases products may be sold years past their expiration date, which can lead to problems like improper curing or bonding;

    "3. Counterfeit goods: These are fake products designed (with varying levels of competence) to look like the real thing. This category is the least common but should be of the highest concern for the industry, as it poses the greatest risk to safety."

    Innovator Profile: 3M on the gray market

    The gray market increases the likelihood that unsafe products or materials can make their way to patients. "When customers buy gray market products, they have no guarantee that the products have been shipped or stored correctly, or that their labels have not been falsified to conceal an expiration date or important safety data," Hearne explains. "In addition to the risks posed by improper handling and storage, the formulation or labeling of these products may not comply with U.S. laws. Any of these factors can compromise product efficacy and patient safety. Furthermore, many channels that are providing gray market products also sell products that are counterfeit. Counterfeit products are of the highest concern because of the safety risk associated with buying a product with a truly unknown composition."

    Incorporating a gray market product into just one part of the workflow can compromise the entire restorative process. "Using a gray market component invokes several short- and long-term risks to consider," says Paul Patella, Director of Key Accounts, Lab Division, Straumann North America. "[Dental technicians face:] paying out-of-pocket on a case redo because many of these gray market companies offer no reimbursement for failed products [or the] potential for legal action; the loss of the referring clinician; and of greatest importance, the patient’s situation is now quite compromised and the laboratory can be at a significant legal risk."

    Next page: Financial concerns ...

    Ryan Hamm
    Ryan Hamm is the Editorial Director for Dental Products Report and Digital Esthetics.

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