Nobel Direct Dental Implants Increase Profits and Lawsuits

Yorba Linda, CANobel Biocare may be reaping the profits from its Nobel Direct titanium dental implants but the "world leader in innovative evidence based dental solutions" (according to its website) might want to put some of its profits away for a rainy day—lawsuits are on the way. The company has received numerous complaints about its implants loosening and/or significant bone loss linked to the implants.

According to Millennium Research Group, implants with orthodontic mini screws, such as the Nobel Direct one-piece implants, are one of the fastest-growing segments in orthodontics and this type of dental surgery is predicted to exceed 30-40 percent from 2007 to 2011.

However, with this growth, complaints about the implants are also increasing. These small-diameter implants involve less surgical time and are allegedly more cost-effective than other traditional implants, but for some patients, the cost of Nobel Direct implants far exceeds the initial price tag, especially when pain and suffering is taken into account.

Orthodontic mini-screws can be placed by orthodontists and tend to be an entry product for orthodontists who are adopting implant treatment. But as of January 31, 2008, orthodontists, their patients and all regulatory bodies worldwide were issued a safety notice from Nobel Biocare and the Swedish Medical Product Agency (MPA), giving notice of clarifications and changes to the instructions for use.

The following statements are part of the enclosed field safety notice:
"The investigation showed that, on average, the marginal bone level around NobelDirect(tm) was normal and did not deviate from what is typically seen around conventional two-piece implants"..."However, some cases were identified where a lower than expected marginal bone level was observed. These cases were analyzed and the conclusion was that the implants were not placed according to the intended protocol. To avoid these problems, clarifications in the instructions for use were found necessary."

The field safety notice further states:
"There is no potential hazard associated with the continued use of the NobelDirect(tm) and NobelPerfect(tm) one-piece implant to the patients, provided the instructions are followed."

Nobel Biocare, headquarted in Zurich, Switzerland, has over 2,200 employees and recorded revenue of more than $883 million USD in 2006. Production takes place at five production sites located in Sweden, USA and Japan.