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July 24, 2002
Updated: August 14, 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. The cause of
meningitis in these cochlear implant recipients has not been established.
The design of the electrode is being considered as a possible factor.
Over a period of 14 years, 52 cases of meningitis have been reported
worldwide to Advanced Bionics Corporation and Cochlear Corporation. These
have occurred in children and adults ranging in age from 21 months to 72
years who have undergone cochlear implantation for severe to profound
deafness. A total of 12 known deaths have resulted from these cases. Two
implant surgeons, Drs. Noel Cohen and Thomas Balkany, have recently
surveyed cochlear implant centers and manufacturers in North America. They
identified 22 cases (of the 52 worldwide cases) of meningitis. Nine cases
were identified in patients with the Advanced Bionics CLARION device, 13
cases with the Cochlear Nucleus device, and no cases with the MED-EL
Corporation device.
Cerebrospinal fluid culture results are available in 14 cases. Although
most cases have been caused by Streptococcus pneumoniae (pneumococcus),
other organisms -- including Hemopohilus influenza, enterococcus, E. coli,
and S. viridans -- have been cultured. The vaccination history against
Pneumococcus was available in 6 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. Most of the patients have been
children, predominantly under the age of 5, but some adults with cochlear
implants have also developed meningitis.
The cause of meningitis in these cochlear implant recipients has not been
established. Some deaf patients may have congenital abnormalities of the
cochlea (inner ear) which predispose them to meningitis even prior to
implantation. Patients who become deaf as a result of meningitis are also
at increased risk of subsequent episodes of meningitis compared to the
general population. Other predisposing factors may include young age (< 5
years), otitis media, immunodeficiency, or surgical technique. The
cochlear implant, because it is a foreign body, may act as a nidus for
infection when patients have bacterial illnesses.
Design of the electrode is also being considered as a possible
predisposing factor. The Advanced Bionics CLARION device differs from
other currently marketed cochlear implants because it uses an additional
piece (i.e., a positioner) which is introduced next to the electrode into
the cochlea to facilitate transmission of sound information to the
auditory nerve. During an ad hoc meeting in Amsterdam on July 5, 2002, a
group of European physicians concluded that there were more cases of
meningitis with the CLARION device than with other cochlear implants and
that this difference may be attributable to the use of the positioner. The
organizers of this meeting recommended that the use of the positioner be
discontinued, and the regulatory authorities of several European countries
(e.g., France, Germany, and Spain) have accepted these recommendations.
Consequently, Advanced Bionics has agreed to discontinue use of the
positioner in these countries and will be marketing one of their current
electrode systems (HiFocus) without the positioner. The company has also
initiated a voluntary recall of the CLARION device in the United States
and has announced that it will be seeking FDA approval for the HiFocus
electrode without the positioner.
Cochlear Corporation, in reviewing all data from North American patients
implanted with the Nucleus device, claims to have an overall incidence of
reported meningitis that is comparable to the incidence of meningitis in
the general population. Cochlear Corporation noted that the majority of
the reported cases of meningitis in these implanted patients had
predisposing factors for meningitis (e.g., Mondini deformity, prior
history of meningitis).
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 (< 5 yr) and the elderly are most
vulnerable to meningitis.
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 appropriate prophylactic perioperative antibiotic treatment,
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. Cochlear implant patients should consult their
physicians about receiving immunizations. At least one cochlear implant
manufacturer provides reimbursement for vaccination.
* 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®) 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®23 and
Pneumovax®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.
Preventing Pneumococcal Disease Among Infants and Young Children
Recommendations of the Advisory Committee on Immunization Practices (ACIP)
October 06, 2000 / 49(RR09);1-38. |
