Primary Concerns With EON And EON Mini Implants?
EON and EON Mini are pain control implants manufactured by St. Jude and are designed to be implanted near the spine. The implant is placed under the skin and connected to the part of the spinal cord that is firing pain signals. While in operation, they send small bursts of electricity through the nervous system and create slight sensations known as paresthesia. This technique is meant to cancel out pain signals sent to the brain and encourage the body to release endorphins, which are used by the body as pain relief. In theory, this is an effective method of pain control, however there are significant flaws with St. Jude’s implant that have forced product recalls.
These implants were approved by the FDA before there was enough data available to confirm whether they were safe or not. In fact, the FDA didn’t even require clinical data from St. Jude before approving the device for use in patients. It’s not completely clear why this was the case, but the thinking is that the FDA was confident that the techniques used in these devices were already considered safe. While true, the implants were not built appropriately to function in the human body.
When the implants were first launched, St. Jude claimed that they would last for at least ten years, but hundreds of patients reported failure within just six months. Most of these failures were attributed to the implant’s battery system, which would unexpectedly fail to charge or deliver power to the implant itself. This led to the first recall in 2011, which was blamed on welding cracks inside the implant’s battery system.
A second recall was sent out in 2012, when additional problems with the implant’s battery system were found. This was blamed on poor manufacturing by one of St. Jude’s battery suppliers and was also responsible for loss of communication with the device or loss of recharging ability. More than 300 patients also reported overheating and burns, believed to have been caused by poor placement and wiring.
These malfunctions can result in additional pain, burns and explant surgeries, which come with their own set of risks. Explant surgeries can result in permanent scarring, additional pain, nerve damage and trauma caused by the surgery itself, which may be fatal. Many lawsuits that have been filed against St. Jude have cited EON and EON Mini product liability concerns and explant surgeries as primary causes for concern.
Hundreds of suits have already been filed against St. Jude due to poor clinical testing of their implants. Many victims have been left with worse pain than they started with, greatly reducing their quality of life. Many suffering damaging side effects of the EON and EON Mini implants have decided to contact a product liability attorney to explore their options.