Stockholm, SwedenIn October 2007, Nobel Biocare issued a safety notice after evaluating more than 2000
Nobel Direct dental implants involved with 1183 patients. Some patients were seen as having a lower-than-marginal bone level and the company concluded that the implants were not placed according to "the intended protocol."
When the implants were launched by the medical devices group in 2004, they were touted as a great innovation, as they could be screwed directly into the jawbone without having to first lift up the mucous membrane. In its marketing campaign, the company targeted less experienced dentists, emphasizing that an implant was easy to use and that it would also counteract marginal bone loss.
Fast forward three years and fewer smiles as the risk of implant loosening increased.
In another study, researchers in Sweden showed that eight percent of the implants failed. The team studied 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," said Par-Olov Ostman, a dentist who presented the study. Another expert noted 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."
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.
In 2006, the Medical Products Agency reviewed NobelDirect's dental implants and found "inadequacies in the instructions for use for the implants," that caused early degradation of the dentine.
The company was given a deadline of January 8, 2007 to explain how it planned to rewrite the instructions and was not permitted to market the product until the new information was available.
On February 26th, 2008 Nobel Biocare said it had been cleared to sell its Nobel Direct and Nobel Perfect implant products following a review by a medical agency. In a separate statement, Sweden's Medical Products Agency said the company had improved the instructions for use of the implants, which could now be sold "without restraint".
Nobel Biocare 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.
Taking into account that more than 70,000 Nobel Direct implants have been placed in the US since 2004, an
Nobel Biocare Dental Implant eight percent failure rate (as reported by the Swedish researchers) could potentially affect more than 5,000 people who may have failed implants or bone re-absorption.