Learning Objectives: Significant bone erosion has been detected in patients who have had mastoid obliteration using Serenocem granules. The lecture will discuss the issues regarding use of new materials. Advice will be given on how to report and investigate adverse reactions and the management of patients affected when things do not go to plan.
Serenocem granules are a ceramic granule produced by Corinthian Surgical in the United Kingdom. They have been marketed since 1997 as an ideal material for obliteration of the mastoid cavity. The author used the granules for mastoid obliteration in 40 cases over a 10 year period. Results were generally good however at recent revision surgery one patient was noted to have significant erosion of the temporal bone adjacent to the granules. Subsequent CT scanning of other patients found bone erosion to be a common finding, occurring in 75% of patients. The product was reported to the medicines and healthcare products regulatory agency (MHRA) and to the company. Other surgeons were contacted and similar findings were noted in their patients. The product was withdrawn by the company. Surgical findings will be illutrated with video. CT scans and histology will be presented. The possible aetiology will be discussed as well as the significant managment issues arising for the patients affected.