Defective Cochlear Implants Sold Despite Failures and Warnings

Advanced Bionics sold defective cochlear implants even after years of reports of the device failing, sometimes causing painful electric shocks in the recipient’s head.

According to an NBC News report, Advanced Bionics, the world’s second largest manufacturer of cochlear implants, learned in 2003 that the device could leak and allow excess moisture inside. Unlike conventional hearing aids, which are worn externally, cochlear implants are implanted inside the skull. An electrode inserted into the cochlea establishes a connection with nerve endings, sending impulses to the the auditory nerve. But excess moisture that entered the HiRes 90K caused many of the devices to fail.

Three months after Grace Bagadiong, born with a condition that left her deaf at age 3, received the HiRes 90K in 2005, the device was recalled because of failures, including reports of painful shocks to the head. Internal company documents obtained by NBC News show warnings dating to 2003, when an engineer said a key component in the implant could leak. Advanced Bionics admitted in 2004 that it hadn’t tested the device in conditions mimicking conditions in the human body. The HiRes 90k was recalled in September 2004 due to “unexplained moisture” causing implant failures, but the device was returned to the market in November 2004. Failure reports continued, yet implant surgeries were performed through 2005 and into 2006. Four thousand devices had been implanted by the time of a second recall in 2006.

Another recipient, eight-year-old Breanna Sadler, had her defective HiRes 90K removed, after she suffered repeated severe electric shocks inside her head, shocks strong enough to thrown her to the ground, convulsing and vomiting. A Kentucky jury awarded the family more than $7 million, finding that company showed reckless disregard for patient safety, according to NBC News. The company has settled cases, including Breanna’s, Grace’s, and others.

In some recipients, the device caused irreparable ear damage. Dick Thomas, 63, received a HiRes 90K after a stroke left him deaf.  The device failed because of moisture. NBC News reports that scar tissue from the first implant complicated a second implant, which also failed. According to Thomas, his third implant barely works.

Advanced Bionics is under new ownership and now claims a reliability rate better than 99 percent. But Nolan Bagadiong, Grace’s father, is angry: “Time and time again they had the chance to fix something wrong, even before it got to us. And then even after it got to us. And it seemed like they chose not to,” he said, according to NBC News.

 

This entry was posted in Defective Medical Devices, Health Concerns, Product Recalls, Recalled Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.