Cause for concern:
A possible (but not proven) link is found
between cochlear implants and meningitis

On July 24, 2002, the U.S. Food and Drug Administration issued a notification that it had received reports of a possible link between cochlear implants and the occurrence of bacterial meningitis.

The FDA is investigating an increase in cases of meningitis among deaf people who have received cochlear implants. Some 55,000 to 60,000 implants are in use worldwide, 22,000 of them in the United States. Children account for around half of the total number of implantees.

"Besides the 22,000 Americans who have them, several hundred thousand more are considered good candidates for the implants But there is great debate among deaf people about the implants, with some questioning their effectiveness and arguing that the use of sign language is preferable because it produces a sense of community."

–Philip J. Hilts,
New York Times

According to the FDA, among those who have received implants during the past 18 years, there have been some 91 confirmed cases of meningitis worldwide, 17 of them fatal. Two well-known otolaryngologists and CI surgeons, Noel Cohen (Mendik Foundation Professor of Otolaryngology, Chairman of NYU Medical Center’s Department of Otolaryngology, and Director of its Cochlear Implantation Program) and Thomas Balkany (Director of the University of Miami Ear Institute), conducted a recent survey that puts the number of confirmed U.S. cases of implantees with meningitis at 22, and estimated 26 unconfirmed cases in Europe, for a worldwide total of 48 so far. Fourteen of the American cases had implants made by Cochlear Limited; 8 had implants from Advanced Bionics.

Between 1984 and 1999, there were only sporadic cases reported in the U.S., some years without any cases at all being reported, but since 2000, 8 have been reported.

According to Philip J. Hilts’ New York Times article (August 3), Dr. Eric Mann, who heads the FDA branch that oversees ENT devices, said "that was hard to determine whether the meningitis cases were linked to the implants. Some people with cochlear defects are susceptible to meningitis, which is a leading cause of deafness, and recurrences are not uncommon."

Even so, the FDA advised implantees to consider getting vaccinated against meningitis. In the same alert issued on July 24, it advised CI and ENT doctors to be alert for the symptoms of meningitis.

In response to the concerns raised abroad about the possible link between its Clarion HiFocus implant and meningitis, Advanced Bionics Corporation removed its HiFocus I and II models from the market in France, Germany, Japan, and Spain, and subsequently, on August 6, stopped selling Clarion implants in the U.S., although the FDA said it would allow the company to re-market the Clarion HiFocus implant without electrode positioners.

This positioner, introduced in 1999, is the part of the Clarion HiFocus model that worries some doctors. It’s used to insert the electrodes into the cochlea, and may leave gaps ("dead space") that can encourage buildup of bacteria that migrate to the fluid that coats the brain. As Hilts notes: "An infection there, by pneumococcal bacteria, is defined as meningitis."

If the symptoms (fever, lethargy, stiff neck, headache, and irritability) are correctly and quickly diagnosed, meningitis can be successfully treated with antibiotics. But if the diagnosis isn’t made early enough, it can be fatal.

"The implants are used to correct severe hearing loss, and the product, implant procedure, and follow-up treatment can cost as much as $70,000."

—Gregory J. Wilcox,
Los Angeles Daily News

Dr. Mann told Hilts that the case against the Clarion implant is "circumstantial only," and noted that there was "no direct cause and effect that we have found. And there are other possibilities."

The law firm of Lieff Cabraser Heimann & Bernstein, LLP, is representing patients who may want to bring legal action against the manufacturer. Any person, whether adult or child, who has suffered a serious infection or injury after having received a cochlear implant, may be eligible to file a claim against the manufacturer. If you believe that you or a member of your family is qualified, you can contact the law firm to discuss your legal rights at no cost or obligation. E-Mail: mail@lchb.com; Website: www.lieffcabraser.com.

Sources:

Gregory J. Wilcox, "Valencia, Calif.-Based Company’s Ear Implants May Be Tied to Meningitis, Los Angeles Daily News, August 7, 2002 (online)

Philip J. Hilts, "Drug Agency Is Studying Ear Implants’ Links to Meningitis," New York Times, August 3, 2002 (online)

FDA Website (fda.gov)

Lieff Cabraser Heimann & Bernstein, LLP Website

AP report, August 24, 2002 (online)


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