CIs and Meningitis Risk
It appears that a CI might slightly increase the risk of
contracting meningitis, and also that some brands of CIs might be more susceptible
than others. Please click the links below for more on this situation.
Advanced Bionics Warns of Pneumococcal Disease
FDA Public Health Web Notification: Cochlear Implant
Recipients may be at Greater Risk for Meningitis
July 2002
Editor: Here's a press release from Advanced Bionics, makers of the
Clarion Cochlear Implant (CI), which warns of a slightly increased risk
of contracting pneumococcal disease among CI users. Please note that the
risk is minimal, but Advanced Bionics is recommending vaccination
against pneumococcal disease. It's probably a good idea for CI users to
check with their doctors.
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Advanced Bionics Corporation has initiated a public health campaign
to increase vaccination against pneumococcal disease, which includes the
potentially fatal pneumococcal meningitis. Advanced Bionics is leading
this campaign because many of its customers - cochlear implant users -
are demographically at higher risk for contracting pneumococcal
meningitis than the public at large; and because a very small number of
cochlear implant users have contracted the disease. Advanced Bionics'
end users rely on the company to assist with their overall health and
wellness. As such, it is our responsibility to educate them on serious
topics that may relate to their health.
Pneumococcal meningitis, the most dangerous form of pneumococcal
disease, was reported in four of Advanced Bionics' users in North
America during the last two years. Although this represents an incident
rate for adults and children of only 0.0005, or less than one-tenth of
one percent, Advanced Bionics initiated a thorough investigation to
determine what action, if any, could help protect our customers from
this dangerous disease. We learned that there is a new vaccine that is
highly effective against pneumococcal disease.
Advanced Bionics believes that communicating about the risks of
meningitis and the availability of this new vaccine is in the best
interest of people with cochlear implants. The company is working with
medical professionals and hearing health organizations on raising
awareness for vaccination.
Editor: A few weeks ago we published a warning from Advanced Bionics
regarding increased risk of meningitis in people who have received
cochlear implants. The Food and Drug Administration (FDA) has just come
out with a similar warning. Here are excerpts from it. The complete
warning is available at http://www.fda.gov/cdrh/safety/cochlear.html.
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July 24, 2002
(You are encouraged to copy and distribute this Notification)
The FDA has become aware of a possible association between cochlear
implants and the occurrence of bacterial meningitis. At least 25 cases
of meningitis have been diagnosed worldwide in children and adults
ranging in age from 21 months to 63 years who have undergone cochlear
implantation for severe to profound deafness. A total of 9 known deaths
resulted from these cases. At this time, 2 out of 3 companies have
reported cases of bacterial meningitis in patients who have been
implanted. FDA is following up with all the manufacturers of cochlear
implants. Surveys of cochlear implant centers currently underway suggest
there are additional, unreported, cases of meningitis in the cochlear
implant population.
Cerebrospinal fluid culture results are available in 11 cases. Seven
have grown Pneumococcus and four have grown Diplococci (most likely
Pneumococcus). The vaccination history against Pneumococcus was
available in 5 cases and none had been vaccinated. The onset of
meningitis symptoms ranged from less than 24 hours to greater than 5
years from time of implant.
Meningitis
Meningitis is an infection of the lining of the surface of the brain.
Early symptoms of meningitis include fever, irritability, lethargy and
loss of appetite in infants and young children. Older children and
adults may also manifest headache, stiff neck, nausea and vomiting, and
confusion or alteration in consciousness. Physicians are encouraged to
consider a diagnosis of meningitis in cochlear implant patients when
such symptoms exist and to begin appropriate diagnosis and treatment as
soon as possible.
The younger patient population (< 2 yr) and the elderly are most
vulnerable to meningitis.
Predisposition to Meningitis
A small percentage of deaf patients may have congenital abnormalities
of the inner ear which predispose them to meningitis even prior to
implantation. Other predisposing factors may include otitis media,
immunodeficiency status, prior history of meningitis, or surgical
technique. The cochlear implant, because it is a foreign body, may act
as a nidus for infection when patients have bacterial illnesses.
Cochlear Implants and Otitis Media
In some of the reported cases of meningitis in cochlear implant
recipients, patients may have had overt or sub-clinical otitis media
prior to surgery or before the meningitis developed. Physicians are
encouraged to consider prophylactic antibiotic treatment prior to
implantation, as appropriate, and to diagnose and treat otitis media
promptly in patients with cochlear implants.
Cochlear Implants and Vaccination
Cochlear implant candidates, as well as those already implanted, may
benefit from vaccinations against organisms that commonly cause
bacterial meningitis, particularly Streptococcus pneumoniae and
Haemophilus influenzae. The immunization status should be ascertained
for all candidates for cochlear implants prior to surgery as well as for
those with an existing implant.
Haemophilus influenzae conjugate vaccines are recommended by the
Advisory Committee on Immunization Practices (ACIP) for all children up
to age 5 years. Heptavalent pneumococcal conjugate vaccine (Prevnar(r))
is indicated for use in infants and toddlers, and is recommended by the
ACIP for all children less than age 2 years, and for children up to age
5 years who are at high risk of invasive pneumococcal infections. The
23-valent pneumococcal polysaccharide vaccines (Pnu-Imune(r)23 and
Pneumovax(r)23) are recommended for children over age 2 years,
adolescents, and adults who are at high risk of invasive pneumococcal
disease. For children age 2 years to 5 years of age who are at high risk
of invasive pneumococcal infections, ACIP recommends use of pneumococcal
conjugate vaccine followed at least 2 months later by 23-valent
pneumococcal polysaccharide vaccine, in order to provide protection
against a broader range of serotypes, although supporting data are
limited1. See individual product labeling for information on dosing and
scheduling of the vaccines. For additional information regarding
immunizations refer to the National Vaccine Program Office of the
Centers for Disease Control and Prevention (http://www.cdc.gov/od/nvpo/).
Reporting Cases of Meningitis in Cochlear Implant Recipients
We encourage you to report cases of meningitis in cochlear implant
recipients. You can report these directly to the device manufacturer or
you can report them to MedWatch, the FDA's voluntary reporting program.
You may submit reports to MedWatch one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/
by telephone at 1- 800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to
MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane,
Rockville, MD 20857.
FDA Contact
Nancy Pressly
Office of Surveillance and Biometrics (HFZ-510)
1350 Piccard Drive, Rockville, Maryland, 20850
Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov
Additionally, a voice mail message may be left at 301-594-0650 and
your call will be returned as soon as possible.
