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Meningitis Cases Tied to Cochlear Implants

Experts warn recipients to be vaccinated against germs

TUESDAY, July 30, 2002 (HealthDayNews) -- A Texas ear surgeon who has implanted hundreds of hearing devices like those recently linked to fatal cases of meningitis said it would be "foolish" to undergo the procedure without getting vaccinated against two forms of bacteria known to cause brain inflammation.

The Food and Drug Administration announced last week that more than two dozen cases of meningitis, leading to nine deaths, have been detected in people who have received cochlear implants in the United States and abroad.

Dr. Peter Roland, a specialist at the University of Texas Southwestern Medical Center in Dallas, said people shouldn't forgo the high-tech hearing aids because of the potential risk. But Roland said anyone who receives them should be immunized against Streptococcus pneumoniae (also called pneumococcus) and Haemophilus influenzae, both of which can cause meningitis, an infection of the brain lining.

FDA officials said 13 cases of meningitis associated with the implants have been confirmed in this country, and seven more are unconfirmed. Two of these involved deaths of children, ages 2 and 3, with the most recent fatality occurring in June.

Officials said germ typing from 11 patients revealed seven confirmed cases of pneumococcus and four likely cases of the bug. As a result, the agency is recommending that people considering implants or who've already received them also consider getting vaccinated against meningitis-causing bacteria. None of the five patients for whom vaccination histories were available had been immunized against pneumococcus, the FDA said.

The infections occurred in the very young as well as the elderly, with ages ranging from 21 months to 63 years, officials said. Symptoms of meningitis sometimes appeared within hours after the procedure, or as long as more than five years later.

Cochlear implants are electronic devices embedded deep in the ear that shuttle sound impulses directly into the auditory nerve. The agency said two of the three American makers of the implants have reported cases of meningitis in patients who received their products, and that preliminary surveys indicate that the problem is larger than reported cases alone would indicate.

Although officials haven't identified the source of the infections -- or even if there truly is an increased risk of meningitis from the devices -- one company, Advanced Bionics Corp., has stopped selling its version of the product. Investigators are focusing on a positioning wedge deployed with that device, called the Clarion, that sits in the inner ear and may be a harbor for bacteria.

Douglas Lynch, a spokesman for Advanced Bionics, said there's "no direct evidence" connecting the wedge and meningitis. However, Lynch said, the majority of cases involving the Clarion occurred in patients who'd received the positioner, which is sometimes not used in Europe.

Lynch said Advanced Bionics first noticed a potential problem earlier this year, and that it seemed centered largely in two areas of Europe. The company reported the infections to the FDA about two months ago, he said.

Ironically, bacterial meningitis is a leading cause of deafness in children -- and thus a principal reason they receive the hearing implants. Children with abnormal earway architecture are at increased risk of the disease.

In addition, children who receive the devices are often in day-care settings, like speech therapy classes, where they're exposed to meningitis-causing germs, Lynch said. For these reasons, experts said, it's hard to determine if the devices are to blame for the meningitis or whether the illnesses aren't simply reflecting a high-odds group.

Roland said officials may ultimately find that the meningitis scare proves unfounded, or that only the positioning component of the Clarion device increases the risk of the disease. "I think it's probably a mixed bag," he said.

Peg Williams, executive director of the Cochlear Implant Association in Washington, D.C., said people considering implants or who already have them should be aware that the surgery, like all operations, carries an infection risk. Still, she said, that shouldn't deter them from seeking the aids.

"It's not an issue I think should create panic or great concern, and I do not think it's enough of an issue that it would create enough of a problem for a person to consider not having an implant," Williams said.

Since the late 1970s, roughly 60,000 children and adults worldwide have undergone the operation, which can restore hearing even to the profoundly deaf. The success of the devices has sparked an emotional debate within some families, as deaf parents worry that if their children receive them, they will become estranged from their children. That tension is easing "considerably," Williams said, as parents discover that the devices don't intrude on their ability to communicate with their children.

What To Do

For more on the investigation, visit the Food and Drug Administration. To find out more about cochlear implants, try the Cochlear Implant Association or Cochlear Implant Central.

SOURCES: Douglas Lynch, director of corporate marketing, Advanced Bionics Corp., Valencia, Calif.; Peg Williams, Ph.D., executive director, Cochlear Implant Association, Inc., Washington, D.C.; Peter Roland, M.D., professor and chairman, department of otolaryngology/head and neck surgery, University of Texas Southwestern Medical Center, Dallas; Food and Drug Administration release
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