|
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  |
|
 | ||
|
|
Updated: September 25, 2003
Original Publication: July 24, 2002
(You are encouraged to copy and distribute this notification)
The Food and Drug Administration (FDA) is notifying healthcare providers about a recent study showing that children with cochlear implants are at greater risk of developing bacterial meningitis caused by Streptococcus pneumoniae than children in the general population. The study, conducted by FDA, the Centers for Disease Control (CDC) and others, was published in the July 31, 2003 issue of The New England Journal of Medicine.2
1CDRH Web Notifications are intended to augment the existing Safety Notification program by providing a mechanism to quickly disseminate device-related safety information that may be beneficial to healthcare providers. Unlike other forms of Notifications, such as Safety Alerts or Public Health Advisories, Web Notifications usually do not make specific recommendations and are typically used in situations where the available information and our understanding of an issue are still evolving.
2Reefhuis J, et al. Risk of Bacterial Meningitis
in Children with Cochlear Implants, USA 1997-2002. N Engl J Med 2003; 349:435-45.
The FDA/CDC study reviewed the medical records of 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 will receive most cochlear implants in the future. Of these patients, 26 were reported to have meningitis. Because the number of meningitis cases is small, we are limited in our ability to determine the risk of developing meningitis with various cochlear implant models.
The FDA/CDC study, however, did show 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 increased the risk for developing meningitis.
Advanced Bionics Corporation, the manufacturer of the cochlear implant devices that have a positioner, stopped distributing these models as of July 2002. Advanced Bionics currently distributes an FDA-approved cochlear implant without the positioner.
It is unknown at this point whether the risk of meningitis in patients whose implants have positioners might be reduced if the implant were removed or replaced by a model that does not have the positioner. Thus, it is unclear whether any potential benefits of explantation would outweigh the risks for operative complications, including perioperative meningitis.
FDA first became aware of the possible association between cochlear implants and meningitis in June 2002. As of May 2003, we have learned of 118 cases of cochlear implant recipients worldwide who developed bacterial meningitis (55 cases in the United States and 63 cases in foreign countries). The patients ranged in age from 13 months to 81 years. The majority of U.S. patients were no older than five (5) years of age, while meningitis cases in the non-U.S. patients were distributed equally among children and adults.
Many of the 118 patients had certain pre-existing risk factors for meningitis, apart from the risks of the implant or the implantation procedure. These included a history of pre-implant meningitis, congenital inner ear deformity, and basilar skull fracture. In U.S. patients, the onset of meningitis symptoms ranged from less than 24 hours to greater than six years post-implant. Thirty-two U.S. patients developed meningitis within one year post implantation, many within the first few weeks of surgery.
Meningitis is an infection in the cerebrospinal fluid (CSF) around the brain and spinal cord. There are two types of meningitis – viral and bacterial. Bacterial meningitis, the more serious of the two, is the type reported in cochlear implant recipients. Patients younger than five years of age and the elderly are most vulnerable to meningitis.
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. Healthcare providers should consider meningitis in cochlear implant recipients when such symptoms exist and begin appropriate diagnostic testing and treatment as soon as possible.
We have received CSF culture results from 69 cases reported worldwide. The results identified the following organisms: Streptococcus pneumoniae (pneumococcus, diplococcus) (46 cases); Haemophilus influenzae (including types B and non-B) (9 cases); Escherichia coli (4 cases); Streptococcus viridans (3 cases); staphylococcus (4 cases); and non-specific bacteria (4 cases).
Currently three manufacturers have been approved by FDA to distribute cochlear implants in the U.S. They are:
(See Appendix B on where to obtain additional information about cochlear implants distributed in the U.S.)
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.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: 240-276-3356
Email: phann@cdrh.fda.gov
Additionally, a voice mail message may be left at 240-276-3357 and your call will be returned as soon as possible.
Complete information on CDC’s vaccine recommendations is available at http://www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm.
Table 1: CDC recommendations on who should receive the Pneumococcal Conjugate Vaccine (PCV7)1 and when the vaccine should be given.
| Age at first dose (months) |
Primary series | Additional dose |
|---|---|---|
| 2-6 | 3 doses, 2 months apart2 | 1 dose at 12-15 months of age3 |
| 7-11 | 2 doses, 2 months apart2 | 1 dose at 12-15 months of age3 |
| 12-23 | 2 doses, 2 months apart4 | Not indicated |
| 24-59 | 2 doses, 2 months apart4,5 | Not indicated |
| 60 months or older | Not indicated6 | Not indicated6 |
1A schedule with a reduced number of total doses is indicated if children start late or have a lapse in vaccination. Children with a lapse in vaccination should be vaccinated according to the catch-up schedule. Note: pneumococcal conjugate vaccine shortage has been resolved. (See MMWR 2003; 52(19):446-447; at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5219a6.htm)
2For children vaccinated less than 1 year of age, minimum interval between doses is 4 weeks.
3The additional dose should be administered 8 weeks or later after the primary series has been completed.
4The minimum interval between doses is 8 weeks.
5PCV7 also can be considered for children 24-59 months of age who do not have cochlear implants, immunocompromised conditions or certain chronic illnesses; if PCV7 is administered to children without these conditions, only one dose of PCV7 is indicated.
6PCV7 is not generally recommended for children
5 years of age or older (see Table 2).
Table 2: CDC’s recommendations on who should receive the Pneumococcal
Polysaccharide Vaccine (PPV23) and when the vaccine should be given:
| Age at presentation (years) |
First Dose | Second dose |
|---|---|---|
| Less than 2 years | Not indicated1 | Not indicated1 |
| 2-4 | Administer2 | Not indicated |
| 5-64 | Administer | Not indicated3 |
| 65 years or older | Administer | Not indicated4 |
1PPV23 is not recommended for children less than 2 years of age.
2Children less than 5 years of age should complete the PCV7 series first; PPV23 should be administered 8 weeks or later after the last dose of PCV7. Recommendations of the Advisory Committee on Immunization Practices 2000;49(RR-9); at http://www.cdc.gov/mmwr/PDF/rr/rr4909.pdf.
3Revaccination is recommended for persons with certain risk factors other than a cochlear implant. CDC. Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices 1997;46(No. RR-8):1-24; at ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4608.pdf
4Revaccination is indicated if the person has not received vaccination within 5 years and was less than 65 years of age at the time of last vaccination.
The Hotline is closed on weekends and federal holidays.
There is a summary of the safety and effectiveness data on FDA’s website for some of the cochlear implant devices. The website is http://www.fda.gov/cdrh/pmapage.html#monthly.
In addition, each US cochlear implant device manufacturer has a website where you can obtain specific information about their products. The websites are:
Updated February 6, 2006
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
