July 25, 2002 -- Nine people have died from a deadly
infection linked to hearing devices called cochlear implants, the FDA
warns. At least 25 children and adults worldwide have developed
bacterial meningitis after receiving the implants.
Three companies manufacture the devices. So far, two of
these companies have reported cases among patients who received their
brands of the device.
The FDA says that an ongoing, urgent survey of cochlear
implant centers suggests that "there are additional, unreported cases of
meningitis in the cochlear implant population." About 60,000 people
worldwide have cochlear implants.
People who have the implants should consider getting
vaccinated against the kinds of germs that most often cause bacterial
meningitis. The FDA says that everyone with an existing implant or who
is about to get one should check to see whether they already have been
vaccinated.
Meningitis is an infection of the fluid and tissue
surrounding the brain and spinal cord. Bacterial meningitis is generally
considered more severe than the viral form.
Cochlear implants aren't your average hearing aid.
Designed for people with deafening nerve damage, the devices are
surgically implanted deep within the ear. They turn sound waves into
electric signals that are passed to nerve fibers leading into the brain.
The devices have restored hearing to many people who cannot be helped by
other types of hearing aids.
Exactly why a cochlear implant might be linked to
bacterial meningitis is unknown. The device itself appears to be germ
free. The implant goes close to the brain, but it seems unlikely that
the device itself is creating a new pathway for germs. It seems more
likely that germs invading the inner ear can cluster on the device and
then get into the bloodstream.
A single kind of germ -- pneumococcus -- causes nearly
all cases of bacterial meningitis. Of the 11 cochlear-implant cases of
meningitis analyzed so far, seven are definitely and four are "most
likely" pneumococcus.
There's already an effective pneumococcal vaccine.
There's one version for adults and children age 2 years and older.
Another form of the vaccine (Prevnar) can be given to children as young
as 2 months old. Because Prevnar is relatively new -- it hit the market
in March 2000 -- many children remain vulnerable. The CDC already
recommends this vaccine for all children.
These cases of bacterial meningitis often occurred a
year or more after implantation. This suggests that vaccination of all
children and adults who get cochlear implants might protect them from
getting bacterial meningitis.
Pneumococcal infection often begins in the middle ear.
The link between implants and meningitis means that people with implants
-- particularly children and elderly adults -- should get immediate and
aggressive treatment for all ear infections.
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
