WASHINGTON (Reuters Health) Jul 25 - The US Food and Drug
Administration (FDA) on Wednesday warned that it has become aware of a
possible association between cochlear implants and the occurrence of
bacterial meningitis.
The FDA said at least 25 such cases of bacterial meningitis have
been diagnosed worldwide in patients ranging from 21 months to 63
years of age. Of those cases, nine have resulted in death.
At this time, two out of the three companies cleared to sell
implants in the US have reported cases, but a survey of implant
centers suggested that there are additional unreported events, the FDA
said in a public health notification posted on its Web site.
But in issuing the warning, the FDA also observed that a small
percentage of deaf patients may be predisposed to inner ear
infections, and that the implants may just be serving as a nidus for
existing infections.
The FDA said physicians should consider a diagnosis of meningitis
in cochlear implant patients when they show symptoms of fever,
irritability, lethargy and loss of appetite. Older patients might also
experience headaches, stiff necks, nausea, vomiting and confusion or a
change in consciousness.
Cochlear implant candidates, and those already implanted, the
agency said, could benefit from vaccinations for streptococcus
pneumoniae and haemophilus. The FDA also said it is encouraging
physicians to consider prescribing pre-implantation antibiotic
treatment to patients with predisposing factors such as a history of
ear infections or a compromised immune system.
