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.
Action that needs to be taken
Medical directors, Ears Nose and Throat departments, and staff involved in the management of patients with SerenoCem Granules are to action the notice by doing a number of things.
For patients with symptoms
- Undertake a clinical review and do a CT scan
- Consider revision surgery and removing the granules and obliteration of bone pate
- Repeat CT scan 2 years if granules remain implanted
For patients without symptoms
- Undertake clinical review and do a CT scan
- Repeat the scan in 2 years to assess the rate of absorption, for all patients with granules implanted for two years or less, if the initial CT scan shows no or limited reabsorption
- Undertake a risk versus benefit assessment if patients request removal of the granules
Action to have systems in place to take action must start from 11th of August 2016 and be completed by 24th of August 2016 – this is not the deadline for the completion of patient follow-up and imaging though.
A recommended distribution list can be found on the Gov.UK website of who should be altered.
All adverse events need to be reported to the appropriate Devolved Administration which can also be found on the Gov.uk website.
Source: https://www.gov.uk/drug-device-alerts/serenocem-granules-risk-of-bone-reabsorbtion-around-granules
UPDATE: PLEASE NOTE THAT WE ARE NO LONGER ABLE TO ACCEPT NEW CASES IN THIS MATTER.
The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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