FDA Warns of Cochlear Implant RisksFeb 6, 2006 | AP
Children with an early version of the cochlear implant face an increased risk of bacterial meningitis beyond just the first two years following implantation of the hearing devices, the Food and Drug Administration warned Monday.
The increased risk means the young implant patients should be monitored as long as the electronic devices are in place for signs of the sometime fatal infection of the fluid surrounding the brain and spinal cord.
Deaf children fitted with the implants and a positioner get bacterial meningitis more often than either children with the implants that don't have the small rubber wedge or those without implants at all, the FDA said in separate letters to patients and doctors.
The rubber wedge originally was used to help doctors position the implants during surgery. Advanced Bionics Corp. was the only manufacturer to sell implants with positioners. None has been implanted since July 2002.
An original study found 26 of 4,264 children with the implants developed meningitis during the first two years following surgery, with those with positioners at greater risk. Now, a new study that followed the same children for an additional two years found another six; all with positioners developed meningitis. The results appear in this month's issue of the journal Pediatrics.
It remains unclear how the positioner increases the risk, the FDA said. Nor does the agency have enough information to recommend surgically removing the devices, given the risk of postoperative infection.
Beyond monitoring cochlear implant patients for signs of meningitis, which include high fever and a stiff neck, the FDA recommends the children receive the proper vaccinations.