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Inside Dental Technology

January 2012, Volume 3, Issue 1
Published by AEGIS Communications

Counterfeiting Epidemic

Product substitution and counterfeit materials hold serious consequences for the patient as well as dental professionals.

By Mark C. Jackson, RDT

One of the most troubling trends in dentistry today is the free substitution of products by both foreign and domestic laboratories. Although, in the case of pirated name-brand products, China seems to be the most common offender—the global menace of counterfeit goods is increasing. The free flow of goods across the world, lack of regulation, and socio-economic conditions are the major factors impacting the sale of counterfeit goods. Coach® handbags, Rolex® watches, and Gucci® eyeglasses are sold at much higher quantities than the actual number of items produced by these manufacturers each year. The counterfeits look remarkably like the authentic products but move through an illegal distribution channel to the consumer. Not only does such counterfeiting activity cheapen these brands, it hurts the actual sales of their products and impacts the bottom line of these companies.

However troublesome the sale of counterfeit watches, handbags, and eyewear is, these products pose no health risk to the consumer. The effect could be much more serious when counterfeiting spreads to healthcare products. Currently, cases of counterfeited healthcare goods, such as medications and medical devices, are assuming critical proportions. The Organization for Economic Co-operation and Development (OECD) and the World Health Organization (WHO) estimate that approximately 6% to 8% of the total global medical devices market comprises counterfeit goods. This percentage does not consider unaudited and unaccounted markets where the problem might be more serious.

Dangerous Dental Products?

The dental industry is not immune from counterfeit products or from fraudulent material substitutions. The author recently spoke to a dentist who said he tried a BruxZir restoration and was not impressed with the material. This was not just surprising, but startling, because in every case the author has been involved in this product, the opposite reaction from clients has been true.

By investigating further, the author found that some laboratories are claiming to have a material “just like BruxZir” and then substituting conventional isostatically pressed and bound framework zirconia, which is not the same material formulation or manufacturing method used to produce BruxZir. The author has also been asked to make adjustments to an IPS e.max® crown fabricated by another laboratory, only to have it ruined in the oven on a regular firing cycle. The failure indicated the crown was fabricated using an ordinary pressed-ceramic material and not IPS e.max lithium disilicate. This could have been a case of material substitution or the purchase of a counterfeit material. Captek™ restorations have been counterfeited for years by substituting very high-noble alloys or gold plating for the real product. Neither produces the bacteriostatic effects that differentiate Captek from cast-metal substructures.

Not only is material substitution fraudulent, altering a doctor’s prescription is also illegal. A serious consequence of counterfeit materials and material substitution is that any resulting product failure cannot be accurately reported and traced because there is no proof that the failed product was in fact the material requested or from where the material originated. Manufacturers are realizing that mislabeled restorations or consumables and product substitution are a serious epidemic. companies such as 3M ESPE have instituted material authentication programs in an attempt to halt the use of counterfeit Lava™ products or the substitution of non-Lava zirconia for framework construction. Steps like these from the manufacturing community as well as the FDA will help crack down on such illegal activities and will continue to increase going forward.

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Figure 1  Note wide flap reflection necessary for titanium mesh removal and implant placement. The apical extent of the flap is necessary not only to remove the mesh but also two fixation screws that need to be placed at a safe distance from the apic

Figure 1

Figure 2  Tenacious soft tissue incorporates around titanium mesh, which is used for ridge augmentation and removed at time of implant placement.

Figure 2

Figure 3  Pre-extraction situation. Tooth Nos. 24 and 25 were planned for extraction, and simultaneous ridge augmentation was planned. Implant placement in these two positions at the conclusion of active tooth movement was also planned.

Figure 3

Figure 4  Cross-sectional views of tooth Nos. 24 and 25 failed to demonstrate the presence of labial and lingual bony cortices.

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Figure 5  Cross-sectional views of tooth Nos. 24 and 25 failed to demonstrate the presence of labial and lingual bony cortices.

Figure 5

Figure 6  Following extractions, it was possible to visualize the facial and lingual bony walls.

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Figure 7  Bone allograft (FDBA) was placed to obturate the extraction sites.

Figure 7

Figure 8  Resorbable mesh was shaped and affixed to the labial cortex with two PLGA resorbable fixation screws. The mesh was passively adapted over the edentulous crest and provided graft containment on the lingual aspect of the grafted defect.

Figure 8

Figure 10  Primary wound closure was achieved; the patient subsequently presented to the orthodontist to replace the archwire; two denture teeth were attached to brackets for esthetic purposes.

Figure 10

Figure 11  Six months after extraction and augmentation, orthodontic therapy was completed and the patient returned for implant placement. Adequate hard and soft tissues were present.

Figure 11

Figure 12  Flapless, computer-guided implant placement was performed. A transmucosal healing mode was chosen, with the placement of standard healing abutments.

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Figure 13  Pretreatment panorex demonstrating hopeless condition of maxillary dentition as well as mandibular molar teeth.

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Figure 14  Severe periodontitis and periodontal abscess on the facial aspect of tooth Nos. 7 and 8. All maxillary teeth were hypermobile and the patient was symptomatic in the anterior sextant.

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Figure 15  Fixed provisional bridge supported by the maxillary second molars and canines.

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Figure 16  The edentulous anterior sextant. Portions of the facial bony wall remain in the maxillary left central and lateral incisor region. The long-standing abscess associated with tooth Nos. 7 and 8 has resulted in total loss of the bony plate in

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Figure 17  The extraction sites of tooth Nos. 9 and 10 were obturated with rhBMP-2/ACS. The presence of a portion of the facial cortex provided space maintenance for bony regeneration. The same biomaterial was placed into site Nos. 7 and 8, but a res

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Figure 18  Primary closure was achieved after bilateral sinus grafting and anterior ridge augmentation. The fixed, provisional bridge was then relieved to avoid pressure on the healing sites and recemented.

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Figure 19  Scanning appliance worn by the patient for CT scan (Fig 19). Fabrication of a surgical template for flapless, computer-guided implant placement would be based on digital information obtained from the scan. Fig 20 demonstrates the cross-sec

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Figure 20  Scanning appliance worn by the patient for CT scan (Fig 19). Fabrication of a surgical template for flapless, computer-guided implant placement would be based on digital information obtained from the scan. Fig 20 demonstrates the cross-sec

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Figure 21  Five months after sinus and ridge augmentation healthy soft tissues were evident and the maxillary ridge was symmetric in the anterior sextant, where one side was originally deficient in ridge width.

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Figure 22  Surgical template, supported by the four remaining teeth and soft tissues. Sequential computer-guided implant placement was used to further stabilize subsequent implant insertions.

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Figure 23  Implant placement in the Nos. 7, 8, and 9 positions. Because the mesh did not require removal, flapless placement was possible. Note that it is visually impossible to distinguish between which side (right or left) was augmented with rhBMP-

Figure 23