Advanced Bionics is the manufacturer of cochlear ear implants. Although these devices can be very effective in helping deaf and hard-of-hearing individuals perceive sound, they have a long history of serious problems.FDA Recalls and Warnings
Cochlear ear implants were recalled because of moisture problems caused by defective seals. The Food and Drug Administration (FDA) has posted several cochlear ear implant recalls and warnings including:
- Posted HiRes 90K Cochlear Implant Device Recall in 2010
- Warned educators that cochlear implants do not make hearing “normal” in 2009
- Warned of the life-threatening risk of bacterial meningitis (a potentially fatal swelling of the brain and/or spinal cord) in patients, especially children, with cochlear implants in 2002, 2003, 2006 and 2007
- Advanced Bionics voluntarily recalled CLARION® and HiResolution® cochlear implants in 2004
In 2007 the FDA’s Center for Devices and Radiological Health sued Advanced Bionics and its President and CEO Jeffrey Greiner saying that the HiRes 90K cochlear implants were “adulterated devices.” The FDA’s complaint lists how Advanced Bionics failed to get premarketing approval for a new “feedthru assembly” component that caused an excessive moisture problem. The excessive moisture exposed patients to the risk of device failure and associated risks of surgical intervention and potential permanent loss of hearing. Although Advanced Bionics recalled the devices, the implants were still shipped and implanted after the recall. The case was settled in 2008 for over $1 million to be paid by Advanced Bionics and $75,000 to be paid by Greiner.
Just this month a Kentucky jury awarded a $7.25 million verdict to a little girl and her family against Advanced Bionics. The little girl had a cochlear device implanted when she was four years old. Four years later the device had an electrical short that shocked her so severely she went into shock and was thrown to the ground vomiting and convulsing. Before the device was removed and replaced 13 months later, she was shocked two more times. Her open-head surgery to remove the device from her skull took more than seven hours. The jury awarded punitive damages because it found that Advanced Bionics delayed revealing the defect so they could sell more devices. That should tell you something.
A deaf girl’s father filed a class action lawsuit against Australian medical device company Cochlear Limited. The girl received Cochlear Limited's Nucleus CI500 cochlear implants in June 2011. The devices failed in both ears by September 2011 and had to be surgically removed. In September 2011 Cochlear issued a voluntary recall based on a manufacturing flaw that created small cracks in the medical devices that allowed water to enter the device and short the electric components. According to the lawsuit, at least 25,000 patients worldwide received the potentially defective cochlear implants. The class action is seeking medical costs associated with removing the failed devices and corrective surgery, punitive damages, attorneys' fees, and a medical monitoring program for the impacted class members.
In 2010 Cochlear had to pay a fine of $880,000 as part of a settlement with the US Department of Justice for violating anti-kickback statutes by offering physicians discounts, gifts, trips and other incentives to implant their devices.... I think you get the point by now. This company was chasing profits hard instead of trying to do the right thing with this life-changing - for good and bad, apparently - medical device.
Some estimates put the rate of failure of these devices at about 25% of the approximately 4,000 implanted worldwide. Plaintiffs lawsuits in these cases alleged that Advanced Bionics failed to disclose to doctors and patients that unacceptable levels of moisture had been reported with the Hi Res 90K cochlear implant. Still, Advanced Bionics continued to distribute the Hi Res 90K despite evidence that the unacceptable moisture levels might cause these implants to fail. There are also allegations that Advanced Bionics did not tell doctors and patients that its cochlear implant program was not in compliance with the federal regulations for medical devices. These deficiencies were later underscored by an FDA's warning letter on February 1, 2005.Potential Side Effects
There are many known cochlear implants side effects and risks from the surgery. These include:
- total loss of natural hearing due to damaged cochlea cells
- bacterial meningitis
- tissue death in the skin surrounding cochlear implants
- injury to the facial nerve during surgery
- cerebrospinal fluid leakage as a result of the surgery
- perilymph fluid leak as a result of the surgery
- skin wound infection
- blood or fluid collection at the surgical site
- attacks of dizziness or vertigo
- tinnitus (ringing or buzzing sound)
- taste disturbances from nerve damage during surgery
- numbness around the ear
- reparative granuloma (localized inflammation if the body rejects the implant)
- general anesthesia risks
If you or a loved one have a cochlear implant, you should watch for the following signs that the implants are failing:
- loss of sound
- discomfort or pain
- intermittent functioning
- sudden loud noises or popping
- Children crying or unwilling to use headphones
In addition, the FDA warns of the following risks associated with cochlear implants:
- May hear sounds differently than “normal hearing”
- May lose residual hearing.
- May not hear as well as others who have had successful outcomes with their implants
- May not be able to understand language well
- May not be able to upgrade their implant when new external components become available
- May not be able to have some medical examinations and treatments such as MRI imaging, neurostimulation, electrical surgery, electroconvulsive therapy and ionic radiation therapy
- Will depend on batteries for hearing. For some devices, new or recharged batteries are needed every day
- Replacing damaged or lost parts may be expensive
- Will have to use it for the rest of life. During a person's lifetime, the manufacturer of the cochlear implant could go out of business. Whether a person will be able to get replacement parts or other customer service in the future is uncertain.
- May have lifestyle changes because their implant will interact with the electronic environment. An implant may set off theft detection systems set off metal detectors or other security systems, be affected by cellular phone users or other radio transmitters, have to be turned off during takeoffs and landings in aircraft and interact in unpredictable ways with other computer systems
- Will have to be careful of static electricity
- May hear strange sounds caused by its interaction with magnetic fields, like those near airport passenger screening machines.