Cochlear implants are medical devices that are meant to provide a great deal of benefit for people who have hearing disabilities.
These devices are mounted inside of the ear and have helped a large number of people to hear better, or to hear again entirely.
While the positive qualities of cochlear implants are many, they are not completely without concern.
One of the major manufacturers of cochlear implants has come under fire as of late because of accusations and increasing evidence that their products may actually cause more harm than good in patients who use them to assist with hearing.
Because of these issues, the manufacturer has issued more than one recall for its cochlear implants, for three different models.
All three models were recalled at several different times.
If you or someone you know has received a defective cochlear implant, you may be able to take legal action.
In fact, a federal jury awarded the parents of a child who suffered adverse effects from one of these implants over seven million dollars in May of 2013.
Cochlear implants are not the same as hearing aids as they are surgically implanted inside the skull of a person who is hard of hearing or deaf.
The device is designed to send electrical impulses to the interior of the cochlea in order to stimulate the auditory nerves.
There are external components of cochlear implants, which include a transmitter, speech processor, and microphone.
The United States Food and Drug Administration (FDA) first approved one of the devices in question in July of 2003.
The implant is considered to be a class III medical device, which is the highest risk class that is established for medical devices.
The manufacturer has been faced with several issues regarding these cochlear implants.
The problems began in 2004 when the company issued a recall of all of the devices that were not yet implanted for two of their models.
Later the same year, the company put the devices back into circulation, before issuing a second recall on them in 2006.
It has been asserted that the implants stopped working properly because of problems with moisture which caused damage to an internal portion of the device.
The FDA filed a civil action against the manufacturer of the cochlear implants in 2007.
The FDA alleged that the manufacturer produced and sold implants that they deemed to be "adulterated".
This means that the devices had been modified without the necessary notification or approval.
The manufacturer settled the suit for just over one million dollars, with an additional seventy five thousand paid out by the CEO.
Also in 2007, the FDA issued a warning that children who had received the cochlear implants had a higher than average risk of developing bacterial meningitis, which is an infection that can be potentially fatal.
This warning came after two children who had received the devices died of the infection.
Other serious hazards of these implants include: death of the tissue in the area that surrounds the implants, and total loss of any natural hearing because of cochlear cells that are damaged during the implantation process.
Still another recall was issued for these cochlear implants in 2010.
The manufacturer recalled one specific model after two patients reported pain and loud noises within ten days following activation.
The device was once again allowed to return to the market one year after the recall.
As mentioned above, a federal jury ruled against the manufacturer of these implants in May of 2013 because one of their implants caused severe levels of damage to a girl in Kentucky.
The parents of the child sued in August 2011 after their daughter suffered the harm in 2009.
The suit was brought forth on the grounds that the company did not properly test the device and did not inform the FDA that it switched to a new supplier for a major component of the device.
The device that was implanted in the child was tested and was found to contain almost thirty nine percent water and vapor, which is vastly higher than the half a percent moisture limit the FDA mandates.
This moisture defect caused the child to suffer three electric shocks, which caused her to vomit and have convulsions.
The lawsuit stated that the trauma of such an experience caused the child to have emotional harm, which kept her from wearing her glasses, eating, sleeping, and carrying out other regular tasks because of fear of being shocked again.
The family was awarded more than seven million dollars in total, with over six million dollars coming in the form of punitive damages, and the remainder being awarded for the pain and suffering the child faced.
If you or someone you know has been implanted with a defective cochlear implant, you should not hesitate to contact a personal injury attorney.
There has been an increasing amount of data that shows cochlear implants are not as safe or beneficial as they have been marketed to be.
Because of this many people needlessly suffer because manufacturer put profits before people.
A personal injury attorney who specializes in defective medical devices can review the details of your case and can advise you on the best way to proceed.
Since most personal injury attorneys work on a contingency basis, you often pay nothing until the time your case settles.
Removing the financial burden from bringing forth a lawsuit can be quite comforting in an already difficult time.
In most cases, compensation can be sought for past, present, and future medical bills, loss of income, pain and suffering, and in some cases for punitive damages.
Punitive damages are a type of legal punishment that is meant to deter those responsible for harm from committing similar acts again in the future.
You should not risk being a victim twice.
It is very important to hold these manufacturers accountable when they are reckless and do not take the proper and necessary to protect patients from undo harm.
Consult with a personal injury attorney today.