Lawyers approached regarding failed cochlear implants
Implants showed higher failure rate than anticipated and were later recalled
Posted on 15 March 2016
Lawyers in the the Consumer Law and Product Safety group at Leigh Day have been approached by the parents of a child whose cochlear implants have failed early.
The child was born with profound hearing loss and, at 10 months old, was implanted with two CI500 series cochlear implants manufactured by Cochlear Ltd. It was anticipated that these implants would last for decades and potentially the child’s lifetime.
Only one week after surgery, the child’s parents received notification that the implants had shown a higher failure rate than anticipated therefore they were being recalled.
By five years following initial surgery, both implants had failed and the child has had to undergo two revision surgeries in order to replace the failed implants. These are two surgeries that the child never should have had to face at such a young age according to Brian McFerran, a product liability lawyer at Leigh Day.
Mr McFerran said: “The surgery to replace these implants is invasive and exposes the patient to the associated risks of surgery including infection and complications associated with general anaesthetic. Naturally, this is distressing situation for both a child and their parents and illustrates why it is imperative that these implants are rigorously tested and demonstrate an extremely low failure rate. Unfortunately, there is no guarantee that the revision surgery will be as successful as the primary surgery”
The Cochlear Nucleus CI500 series cochlear implant was voluntarily recalled by the manufacturer in September 2011. In 2014 they reported a failure rate of 7.2% in children at 5 years. It is thought failure is brought about by moisture entering the implant, eventually causing an electrical fault in some cases.
The child was born with profound hearing loss and, at 10 months old, was implanted with two CI500 series cochlear implants manufactured by Cochlear Ltd. It was anticipated that these implants would last for decades and potentially the child’s lifetime.
Only one week after surgery, the child’s parents received notification that the implants had shown a higher failure rate than anticipated therefore they were being recalled.
By five years following initial surgery, both implants had failed and the child has had to undergo two revision surgeries in order to replace the failed implants. These are two surgeries that the child never should have had to face at such a young age according to Brian McFerran, a product liability lawyer at Leigh Day.
Mr McFerran said: “The surgery to replace these implants is invasive and exposes the patient to the associated risks of surgery including infection and complications associated with general anaesthetic. Naturally, this is distressing situation for both a child and their parents and illustrates why it is imperative that these implants are rigorously tested and demonstrate an extremely low failure rate. Unfortunately, there is no guarantee that the revision surgery will be as successful as the primary surgery”
The Cochlear Nucleus CI500 series cochlear implant was voluntarily recalled by the manufacturer in September 2011. In 2014 they reported a failure rate of 7.2% in children at 5 years. It is thought failure is brought about by moisture entering the implant, eventually causing an electrical fault in some cases.