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FDA on importance of vaccinating children who are cochlear implants recipients to ward off meningitis

Below is a letter the Food and Drug Administration sent to doctors regarding the risk of meningitis in children who are implanted with cochlear implants.

October 10, 2007
Dear Healthcare Provider:

This is to remind you of the increased, life-threatening risk of bacterial meningitis in cochlear implants recipients and the importance of fully immunizing these patients.

Although all cochlear implant recipients appear to be at some increased risk of bacterial meningitis caused by Streptococcus pneumoniae, those children implanted with cochlear implants that have a positioner are at greatest risk. The only model with a positioner was withdrawn from the market in July, 2002.

Recent deaths
FDA has become aware of two deaths from meningitis within the past year in children implanted with the cochlear implant with positioner.

Neither of these children was fully immunized according to the CDC recommended vaccination schedule (see link below).

These children, ages 9 and 11, had completed only part of the recommended pneumococcal vaccinations for their age group.

At least one of these children had meningitis caused by a serotype of Streptococcus pneumoniae that may have been prevented by proper vaccinations.

Failure to immunize
A recent survey of the Johns Hopkins University cochlear implant patient population, conducted by Dr. John Niparko, revealed that despite repeated information bulletins from the University regarding the importance of vaccination, 29% of the parents/guardians of patients under 2 years of age were uncertain of the child’s vaccination status.

Vaccination status was unknown in 43% of children older than two years, and 12% were known to be not properly vaccinated. These findings strongly suggest that patients are not receiving vital preventive care that can reduce their risk of this life-threatening illness. FDA is working with the CDC, cochlear implant manufacturers, and professional societies to heighten awareness of the importance of vaccinations in the cochlear implant population.

Recommendations to decrease the risk of meningitis in cochlear implant recipients
Follow CDC’s vaccination recommendations. CDC has issued recommendations regarding which vaccines cochlear implant patients should receive and when the vaccines should be given.

Because children with cochlear implants are at increased risk for pneumococcal meningitis, CDC recommends that they receive pneumococcal vaccination under the same schedules that apply to other groups at high risk for invasive pneumococcal disease.

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 may include high fever, headache, stiff neck, nausea or vomiting, discomfort looking into bright lights, and sleepiness or confusion. Patients may also present with ear pain and/or ear infection. 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, according to American Academy of Pediatrics clinical practice guidelines, healthcare providers should diagnose and treat otitis media promptly in patients with cochlear implants. They should also consider antibiotic therapy more readily in this population than others.

If you were a recipient of Advanced Bionics HiRes90k Implantable Cochlear Stimulators, and have experienced physical or emotional injuries due to a malfunctioning implant, please complete the form below. A representative from our firm contact you as soon as possible.

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