About the 2002 Study
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Background
In summer 2002, the U.S. Food and Drug Administration
(FDA) began receiving reports of bacterial meningitis occurring among
people who had cochlear implants. In response, the Centers for Disease
Control and Prevention (CDC), with the FDA and the health departments of
36 states, the District of Columbia, Chicago, and New York City, began an
investigation.
Conducting the Study
The purposes of the study were (1) to find out how
many children who had cochlear implants got bacterial meningitis
afterwards and (2) to find out what factors might make it more likely that
someone would get meningitis after getting a cochlear implant. The study
was limited to children who were 6 years of age or younger when they got
their implant because the majority of cases reported were in children in
this age group, and because children in this age group will receive most
implants in the future. Children who had received their implant during the
period from January 1, 1997, through August 6,
2002 were included. Potential cases of bacterial meningitis were
identified from reports to implant manufacturers, the FDA Adverse Events
Reporting System, and CDC and state and local health department tracking
systems. In addition, study researchers contacted the parents of all the
children in this group to ask them if their child had been seriously ill
since getting the implant.
Some Basic Facts About the Study
-
A total of 4,262 children 6 years of age or younger
received a cochlear implant during the period from January 1, 1997,
through August 6, 2002. This large study group was used to estimate how
many of the children with cochlear implants got bacterial meningitis. This
number was then compared with the number of children of this age in the
general population who got bacterial meningitis.
-
A smaller study group was used to find what factors
made it more likely for someone with an implant to get meningitis. This
smaller study was made up of all 26 children with confirmed bacterial
meningitis and a random sample of 200 children with implants who did not
get bacterial meningitis after receiving the implant.
-
Detailed interviews of parents were done only for the
small study group. A review of medical records was also done.
-
The study was limited to children who received their
cochlear implants in the United States.
Study Findings and Conclusions
The study found that:
-
Bacterial meningitis occurred more often in children
with all types of cochlear implants than in children of the same age group
in the general population.
-
The majority of cases of meningitis were caused by S.
pneumoniae, a type of bacteria.
-
Children with an implant with a positioner were much more likely to get
bacterial meningitis than children with other types of cochlear implants.
(The implant with a positioner was voluntarily taken off the market by the
manufacturer in July 2002.)
-
Because the study was not able to find out how the
positioner increased the risk for bacterial meningitis, it was not clear
whether removing the implant would lower the risk and we cannot make
recommendations about that. The removal procedure could place the child at
risk for meningitis or other related complications following surgery.
-
Children with a cochlear implant who had inner ear
malformations and cerebrospinal fluid leaks were at increased risk for
bacterial meningitis.
Recommendations
-
Children should be up to date on vaccines at least 2
weeks before having a cochlear implant if they are not already up-to-date
on these vaccinations. (Specific vaccine recommendations for children with
cochlear implants are included in the Questions and Answers.)
-
Parents of children who have already received an
implant should check with their child’s doctor to ensure that their child
is up to date on all vaccinations.
-
Doctors and other health care providers should review
vaccination records of their patients who are cochlear implant recipients
or candidates to ensure that they have received pneumococcal vaccinations
based on the age-appropriate schedules for high risk people and that they
have received age-appropriate Hib vaccinations.
-
Parents of children with cochlear implants should be
watchful for possible signs and symptoms of meningitis (which are listed
in the Questions and Answers) and seek prompt
attention for any bacterial infection their child might
have. Any questions parents have about their child’s health should be
discussed with the child’s doctor.
-
Parents of children with cochlear implants should also
be watchful for signs and symptoms of an ear infection, which can include
ear pain, fever, and decreased appetite.
-
Parents should seek prompt medical attention for any
possible ear infections.
-
Parents should talk about the risks and benefits of
cochlear implants with their child’s doctor and should discuss whether
their child has certain medical conditions that might make him or her more
likely to get meningitis.
Home
| About the 2002 Study |
About the 2004 Study |
Recommendations |
Questions and Answers | Resources (pdf)
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Date:
October 27, 2006
Content source: National Center on Birth Defects and Developmental
Disabilities