The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products.The MPA decision directs Nobel Biocare to clearly describe possible causes for the breakdown of the jawbone in the instructions for use and training programs. In addition, the company must describe how the risk for breakdown can be avoided. In sales and promotion information and instructions for use, the company shall indicate the user qualifications and skills required so that a dentist can use the implants safely. Nobel Biocare may not actively market the dental implants until the information activities are carried out.
The MPA`s report gives an interesting insight into the basis and timeline of this investigation.