The Development of A Central Register for Side Effects of Biomaterials

Abstract

Examination of the interaction between biomaterials and tissues from a clinical realistic as well as scientific viewpoint to complement the highly advanced experimental and biochemical basis research is an undertaking that has suffered a considerable amount of neglect in the past.

Attempts to realize internationally a Central Registry for documenting clinically relevant side effects will be reported in detail. Implementation of the registry involves the review of present literature (prospective clinical studies retrospective studies and case reports). An “incompatibility incident report/questionnaire” has been developed according to the guidelines of the “Report on Pharmacological Side Effects” of the Pharmaceutical Commission of the German Medical Association. The aims of registering and evaluating these reports will be demonstrated and discussed in detail.