Category: Medical
SerenoCem Ear Cement and Granules – risk of bone reabsorbtion
UPDATE: PLEASE NOTE THAT WE ARE NO LONGER ABLE TO ACCEPT NEW CASES IN THIS MATTER.
Corinthian Surgical Ltd issued a Field Safety Notice in March 2016 about bone reabsorbtion around granules implanted in the middle ear. Patients that were implanted with SerenoCem Granules for destruction of the mastoid cavity are possibly affected.
Patients did not show any symptoms, but reabsorbtion showed up on a CT scan. The reabsorbtion varied from being limited to extensive.
There are clinical risks associated with bone reabsorbtion in the middle ear such as inflammation (that can be infective), which can lead to infection and inflammation of the middle posterior fossa dura, facial nerve, and the inner ear. This can lead to more serious risk such as meningitis, loss of hearing, and facial palsy. However there have been no report of these complications.
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