FDA Issues Updated ‘Advice for Patients’ Regarding Meningitis Risk Associated with Cochlear Implants

Cochlear implants are implanted electronic hearing devices that are designed to produce useful hearing sensations people with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.

The devices are designed to help severely to profoundly deaf adults and children who get little or no benefit from hearing aids. Individuals with severe or profound “nerve deafness” may also benefit from cochlear implants.On September 25, 2003 (updating original notice of July 24, 2003) the Food and Drug Administration (FDA) notified 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.”

Bacterial meningitis, a serious infection in the cerebrospinal fluid (CSF) around the brain and spinal cord, can be fatal.

That study was conducted by FDA, the Centers for Disease Control (CDC) and others, and was published in the July 31, 2003 issue of The New England Journal of Medicine. “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.”

The FDA/CDC study reviewed the medical records of 4,264 children under the age of six at the time of implantation. Of these patients, 26 were reported to have meningitis. Because the number of meningitis cases was small, the FDA stated it was “limited in our ability to determine the risk of developing meningitis with various cochlear implant models.”

Although the FDA/CDC study did show “cochlear implants with electrode positioners were associated with a greater risk of developing meningitis than implants without positioners,” it was unable to determine how the positioner increased the risk for developing meningitis.

A positioner is a small rubber wedge that helps the physician position the implant during surgery. Only Advanced Bionics Corporation sold an implant that had a positioner, and none were implanted after July 2002.

On Monday, however, the FDA posted an updated advice for patients that “gives the latest information on the risk of bacterial meningitis in children with cochlear implants and recommends steps to reduce the risk.”

A new study, published in the February issue of Pediatrics, “which followed the children for two more years, has found that the increased risk for meningitis persists beyond two years after implantation. This study highlights the importance of continuing to monitor children with cochlear implants for signs of middle ear infection and meningitis. Children need to be monitored for as long as the implant is in place.”

Based upon the findings in the new study, the FDA published the following recommendations:

“Continue close monitoring for meningitis and middle ear infections for all children with a cochlear implant, but particularly for children whose implants have a positioner. Consult your implanting doctor to determine if the patient has a positioner. It is, however, important to monitor all cochlear implant patients.

Check the patient’s record of vaccinations against CDC’s recommendations (www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm), which show what vaccines cochlear implant patients should receive and when the vaccines should be given. The CDC Immunization Center telephone number is 800-232-4636. The TTY number is 888-232-6348.

Contact your doctor immediately if the patient has any symptoms of meningitis or middle ear infection. These may include: high fever; headache; stiff neck; nausea; vomiting; irritability; confusion; ear pain; hearing loss; loss of appetite; sleepiness or tiredness; or discomfort when looking into bright lights.

Follow your doctor’s prescription for antibiotics very carefully. It is very important that you make sure the patient takes the antibiotic as often as prescribed and for as long as prescribed, so it can work properly.”

The latest FDA advice notes that the new study “followed children from the original study for an additional two years. Six children with positioners developed meningitis after two years. Of these six, three developed meningitis between three and four years after implantation. Children in the study without a positioner did not develop meningitis, but this group of children was so small it is hard to predict the risk of their developing meningitis. The study also concluded there is not enough information now to recommend surgical removal of devices with a positioner.”

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