Nobel Biocare issued a safety notice in October of last year, after evaluating more than 2000 implants involved with 1183 patients. According to the company, their conclusions showed that, on average, marginal bone levels around Nobel Biocare were normal and didn't deviate from what is typically seen around conventional, two-piece implants.However, some patients were seen as having a lower-than-marginal bone level. Nobel Biocare concluded that the implants were not placed according to "the intended protocol."
In other words, they may not have been installed correctly.
According to a December 20th report in ScienceDaily online, Nobel Biocare implant technology was touted as an implant that was easy to use, and therefore suitable for less-experienced dentists. The company has since revised the first page of its 'Instructions For Use (IFU)' with an emphasis that installation instructions and protocols be carefully followed. In addition, the field notice articulates the recommendation that all new users (dentists) attend a training course. Various procedures were clarified.
Nobel Biocare dental implants were launched to great fanfare in 2004 by Nobel Biocare AB, and were considered a landmark innovation as the titanium implants could be screwed directly into the jawbone without having to first lift the mucous membrane.
However, in the three years since the implants have been available there have been problems, to the point where researchers at the Sahlgrenska Academy in Sweden launched an investigation.
The study followed 48 patients who were amongst the first to receive the dental implants. "For each passing year, we have been able to see how the problems related to these implants have grown more and more," says Par-Olov Ostman, a dentist who presented the study just before Christmas.
After the first year, approximately five percent of the implants had been lost, and 20
percent of the implants that remained demonstrated bone loss of more than three millimeters. After three years, (the latest information available) the implant loss rate was up to eight percent, with 25 percent of the remaining implants showing bone loss of more than three millimeters.
"We believe that the problems related to Nobel Direct result both from the design of the implant and an uneven surface against the soft tissue in combination with the method of treatment recommended by the company," said Professor Lars Sennerby.
Invented by Professor Per-Ingvar Brånemark at the Sahlgrenska Academy in the 1960s, the dental implant is a type of artificial dental root made of titanium. The titanium screw is surgically inserted into the jawbone, and must become well secured there so that after several months, it can be used as a foundation for crowns, bridges and dentures. The uniqueness of titanium is rooted in its capacity to be osseointegrated.
Nobel Biocare implant patients with an interest in pursuing litigation for their implant problems will have their litigation plans compounded by a couple of issues: the fact that the implants may not have been installed correctly, which puts the onus either on the practicing dentist, or a combination of the dentist and the company, if the instructions for implant installation were lacking in any way.
And there is the matter of a potential patent infringement. As noted above, titanium implants have been around for about 40 years, and Nobel Biocare may not be the only game in town.
To that end, Materialise has launched a US lawsuit against Nobel Biocare for patent infringement. At issue are NobelGuide drilling templates, which Materialise infers is an infringement on its own, patented SurgiGuide technique.
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"With this lawsuit, we are protecting our technology," says Bart Swaelens, CEO of Materialise Dental. "Our 'SimPlant' software was launched in 1991, and was followed by our 'SurgiGuide' drill guides in 1999. The introduction of NobelGuide by Nobel Biocare, on the other hand, did not occur until 2005."The patent infringement lawsuit in the US is modeled after a similar lawsuit in Europe. This past August the District Court of Dusseldorf ordered Nobel Biocare AB and Nobel Biocare Deutschland GmbH to stop offering the NobelGuide drilling templates in Germany, finding that they infringed Materialise's analogous European Patent No. 0 756 735.
That decision is subject to an appeal by Nobel Biocare, which is pending at the Düsseldorf Court of Appeals. In the meantime, any litigation within the context of the failing Nobel Biocare dental implants would most likely have to wait until the patent suit, filed in the Central District of California, is decided.
