Nobel Direct – too risky to use except with `great care`

Sweden`s Medical Products Agency has made a preliminary finding that Nobel Biocare AG`s dental implant Nobel Direct, is too risky to use except with `great care`. The regulator said it will over the next few weeks come to a final view on Nobel Direct and what eventual warnings will be attached to the implant. The agency issued its statement after investigating the results of Nobel Biocare`s own two year study and said this study was not based on a representative sample, and that up to two thirds of the requisite information from the study was not included in the report it received. `Against this background, …. it is our view that implants of the Nobel Direct type should only be used with great care,` the agency said.

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