CI with Positioner Poses Continuing Meningitis Threat
Editor: The FDA has just issued a notice warning that children
who received a cochlear implant with a positioner continue to be at
increased meningitis risk beyond 24 months after implantation. Here's
the information as posted at http://www.fda.gov/cdrh/safety/020606-cochlear.html
~~~~~~~~~~~~~~~~~
FDA Public Health Notification: Continued Risk of Bacterial
Meningitis in Children with Cochlear Implants with a Positioner Beyond
Twenty-Four Months Post-Implantation
February 6, 2006
Dear Healthcare Provider:
This is to call your attention to updated information on the risk of
bacterial meningitis in children with cochlear implants, and to provide
recommendations for decreasing the risk. A new CDC/FDA study has shown
that children with cochlear implants with a positioner remain at
increased risk of bacterial meningitis caused by Streptococcus
pneumoniae beyond 24 months post-implantation. Cochlear implants with a
positioner were manufactured only by Advanced Bionics Corporation. None
have been implanted since July, 2002.
The new study, published in Pediatrics, (February 2006, Vol. 117,
Issue 2, http://pediatrics.aappublications.org/) followed the same
cohort of children identified in an earlier CDC/FDA study for an
additional 2 years. After 24 months post-implantation, children with
cochlear implants with a positioner continue to be at greater risk of
developing bacterial meningitis than children with cochlear implants
with no positioner or children in the general population. Six children
developed meningitis after 24 months post-implantation. All of those
children had cochlear implants with a positioner.
These findings underscore the importance of continued monitoring and
prompt treatment of bacterial infections in children with cochlear
implants beyond two years post-implantation, particularly among children
whose implants have a positioner.
It is still unknown whether the risk of meningitis in patients whose
implants have a positioner might be reduced if the implant were removed
or replaced by a model that does not have the positioner. Any potential
benefits of explantation surgery must be weighed against the risks for
operative complications, including perioperative meningitis. The present
study concludes that there is currently insufficient information to
support a recommendation for elective surgery to explant devices with a
positioner.
Recommendations to decrease the risk of meningitis in cochlear
implant recipients
These recommendations have not changed from the 2003 recommendations.
* Follow CDC's vaccination recommendations. CDC has issued
recommendations about which vaccines cochlear implant patients should
receive and when the vaccines should be given. These vaccine
recommendations continue to apply to all children with a cochlear
implant, with or without a positioner, and all potential implant
recipients. Healthcare providers and families should review vaccination
records of current and prospective cochlear implant recipients to ensure
that the patient is current on all the CDC recommended vaccinations.
These recommendations are available on the CDC's website at www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm.
* Recognize the signs of meningitis early. Cochlear implant
recipients, along with their families, educators, daycare and healthcare
providers, need to be aware of the signs of meningitis. This can help
ensure early detection and treatment of this life-threatening illness.
Early intervention is vital in successfully treating the infection and
minimizing permanent neurological damage. Early signs of meningitis
include high fever, headache, stiff neck, nausea or vomiting, discomfort
looking into bright lights, and sleepiness or confusion. A young child
or infant with meningitis might be sleepy, cranky, or eat less.
* Diagnose and treat middle ear infections promptly. In some of the
meningitis cases reported to FDA, cochlear implant recipients had signs
of middle ear infection (otitis media) prior to surgery or before the
meningitis developed. For this reason, healthcare providers should
diagnose and treat otitis media promptly in patients with cochlear
implants.
* Consider prophylactic antibiotics. Healthcare providers should
consider prophylactic antibiotic treatment perioperatively in children
receiving cochlear implants.
Advice to Patients with Cochlear Implants can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/020606-cochlear.html.
Background information
The original CDC/FDA article on this topic was published in the July
31, 2003 issue of The New England Journal of Medicine (http://content.nejm.org/cgi/content/full/349/5/435).
The original FDA Notification on the Risk of Bacterial Meningitis in
Children with Cochlear Implants, which was last updated on September 25,
2003, can be found at http://www.fda.gov/cdrh/safety/cochlear.html. The
2003 Notification includes additional information on the background of
this issue not included in this update.
The 2003 CDC/FDA study assessed the risk of meningitis among 4,264
children under the age of six at the time of implantation. The focus of
the investigation was young children because they account for the
majority of known meningitis cases and represent the population that now
receives a large proportion of cochlear implants. The study showed that
children with cochlear implants are at greater risk of developing
bacterial meningitis than children in the general population and that
cochlear implants with electrode positioners were associated with a
greater risk of developing meningitis than implants without positioners.
The study was unable to determine how the positioner might increase the
risk of developing meningitis.
Reporting cases of meningitis in cochlear implant recipients
We encourage you to report cases of meningitis in cochlear implant
recipients. You can report cases directly to the device manufacturer or
you can report them to MedWatch, FDA's voluntary reporting program. You
may submit reports to MedWatch one of four ways: online at http://www.fda.gov/medwatch/report.htm;
by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to
MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857-9787.
Contacting FDA
If you have questions about this notification, please 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. You may also leave a voice mail message at
301-594-0650 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the
Internet at http://www.fda.gov/cdrh/safety.html. You can also be
notified through email on the day the Notification is released by
subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.
Sincerely yours,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
