Cochlear Implant Shocks Patients’ Brains
Posted in Drug & Medical Devices on March 14, 2014
For many families, cochlear implants are a modern miracle, restoring the hearing of a deaf loved one. Sadly, for hundreds of recipients of one cochlear implant, the dream of hearing birds sing or someone say “I love you” has turned into a nightmare.
Reports indicate that over 1500 HiRes 90k cochlear implants have failed due a leak that causes the build-up of excess moisture. This moisture caused some patients to experience severe electrical shocks, causing convulsions, vomiting, and other adverse effects.
Manufactured by Advanced Bionics, the device consists of two main parts: an internal component, which doctors surgically implant in the skull and an external component that sits outside the ear. These two parts are connected by the “feedthru,” which must remain waterproof.
According to an investigation by NBC News, Advanced Bionics knew as early as 2003 that the feedthru “may be vulnerable for a potential leak.” The device was recalled in 2004, but was quickly returned to the market later that same year. In 2005, the FDA sent a warning letter to Advance Bionics and in 2006 a second recall was issued, affecting more than 4,000 recipients of the device.
Despite a myriad of reports detailing device failure and other warning signs, such as internal Advanced Bionics memos, patients — including children — continued to receive implants during 2005 and into 2006.
“I think those human beings made a terrible decision,” said Dr. Arun Gadre, a professor of otolaryngology and head and neck surgery at the University of Louisville. “When you start putting profits before people, because that’s the only way I can interpret this, if you start putting profits before people it never comes to a good end. There’s no way that could ever come to a good end.”
A third recall was announced in 2010, after recipients experienced severe pain, overly loud sounds and shocking sensations shortly after the initial activation of their device.
In March 2013, a jury awarded more than $7.2 million, including nearly $6.3 million in punitive damages to the parents of a West Virginia girl who had been severely shocked by the HiRes 90k.
The jury in the lawsuit, filed in the U.S. District Court for Western Kentucky, found that Advanced Bionics did not properly test the implant before it hit the market and never told the FDA that it had switched the manufacturer of a key component to a different vendor.
Source: “Defective cochlear implants shocked kids — even though company had been warned” by Michael Kosnar and Lisa Myers, NBC News, March 14, 2014.