Imagine that you are an ordinary patient and have just entered a fairly standard procedure - maybe you got a new crown, or a small bridge. Your dentist has placed a crown made of zirconia instead of gold, and you are happy about it - it is much cheaper than gold restorations, and the dentist explains its strength and duration. In addition, it looks good.
After you go home, in the next few days, you start to have a headache. You feel tired and you are not sure what the problem is. You want to know if you can respond to what you eat, or what you have touched. You go back to the past few days and see if there is any change in your diet or activities. However, nothing but ... you just got a crown made of zirconia, nothing to think of. You want to know:
This story may sound far-fetched, but in fact it may be more common than you think, at least according to digital aesthetics and many sources for this article. This may be because materials, equipment, and dental supplies enter the United States through regulatory, market, and government standards. The shadow availability of such goods outside of normal business models describes something called the gray market. Dentists and dental technicians are often lured by the low prices and false promises of the gray market.
What is a grey market?
The gray market may be difficult to define precisely, but usually in the dental context it refers to any dental product, supply or dental equipment that somehow avoids the regulatory process. "When we talk about the gray market, we talk about products that are sold through unsecured supply chains," explained Simon Hearne, "These fall into three main categories:
"1. Products transferred from authorized channels: These products are usually not in compliance with local laws, and may be degraded due to improper handling or improper storage conditions;
“2. Repackaged or Relabeled Products: This practice usually occurs on products that are close to the end of their warranty period. Grey Market distributors may change or cancel the expiration date and repackage the product to sell it to unsuspecting buyers. Selling for several years before the due date, this may result in incorrect curing or adhesion problems;
"3. Counterfeit products: The design of these counterfeit products (with varying degrees of capability) looks like real things. Such products are the least common, but they should be the industry's most concerned issue because it poses the greatest threat to security. risk".
The grey market has increased the possibility of unsafe products or materials that may lead to patients. Hearne explained: "When customers buy grey market products, they cannot guarantee that the products have been properly transported or stored, or that their labels have not been forged to hide expiration dates or important safety data." "In addition to incorrect handling and storage In addition to the risks involved, the formulation or labelling of these products may not be in compliance with U.S. law, and any of these factors may affect product efficacy and patient safety. In addition, many channels also provide counterfeit products for sale in gray market products. Counterfeit products are the most affected. Concern, because buying a product is really a security risk for unknown components. "
Including grey market products as part of the workflow may jeopardize the entire recovery process. "Using the grey market component raises some short-term and long-term risks that need to be considered," said Paul Patella, principal head of Straumann’s North American Laboratory Division. "[Dentist technicians face:] redo cases out of pocket, because many of these gray market companies do not provide the cost of reimbursement for failed products [or] possible legal proceedings; the cost of referring clinicians; and, most importantly, the patient's condition Now that it is already dangerous, laboratories may face significant legal risks. "
In addition, there are economic consequences of buying from unclear sources. "The lab owners should be very concerned because if they buy products from unauthorized dealers, they may not get what they paid for," said Wayne O. Ledford, vice president of sales at Ivoclar Vivadent. “In addition, if there is a problem with the product in the laboratory or in the mouth, where does the lab ask for support?
In the U.S., gray market goods are usually sold or shipped to avoid notification from the regulatory agency, the Food and Drug Administration (FDA). The FDA is responsible for isolating harmful medical supplies in the United States and ensuring that the materials and products used in the patient's mouth are safe for dental teams and patients. Typically, this means that the FDA must approve all items that enter the patient's mouth, including dental materials. How can unapproved things pass through the final consumer?