A Story of Faith
Faith Barnikel was sixteen months old in 2001 when she received her first cochlear implant at John Hopkins. Robert, her father, felt confident that he did his research well and they chose an implant from Advanced Bionics. For ten months, everything seemed to be going well. Faith’s mom, Theresa, found their days filled with therapy sessions as Faith learned to make sense of the sounds coming in through her implant.
Then one day, Theresa noticed that Faith wasn’t responding with her implant. She expressed her concerns to the implant team and for nine months, Faith underwent testing to determine what, if anything, was wrong. An X-ray showed nothing. Advanced Bionics sent out a representative to do some testing but the results showed that there was nothing wrong with the device. Finally, a cat scan showed that the internal array had migrated and the team turned off several electrodes.
“About that time we received a letter about a recall from Advanced Bionics, but the symptoms in the letter were different from what Faith was experiencing,” said Theresa.
“We decided to re-implant one week before Faith’s fourth birthday because Faith was not getting consistent responses with her implant,” Theresa explained. “A few months later we received another letter from Advanced Bionics. There was another recall—this one on the device we had just implanted. When they removed the first device, Hopkins discovered that the array had fused into her skull bone.”
Advanced Bionics issued three different recalls for their devices: in September 2004, March 2006 and September 2009. The recalls in September 2004 and March 2006 involved quality control issues related to moisture in the implanted device. The September 2009 recall involved internal magnet corrosion due to the magnet not being laser welded prior to shipping.
“We went through two years of AVT thinking that she just needed more work but the real problem was that the implant was not working, not the therapy,” Theresa recalls. “I had to quit work because there was so much going on and we had two other kids as well. Then we got the second recall letter and it was a waiting game. Every time Faith would say something about the implant, we’d hold our breath thinking that it was going to fail. For two years it was an emotional rollercoaster thinking that it might fail.”
In January, 2008, Faith’s second implant failed, but again, they went through rounds of testing to try and figure out what was wrong. “Advanced Bionics again hooked up all their equipment and told us ‘It doesn’t look like the device has failed.’ They couldn’t find anything wrong,” Theresa recalled. “But Faith was having headaches and fevers.” The audiologist later said after the device was explanted that they got the report showing that there was a leak and that the report indicated it could fail at any time or years later.”
Looking back, Theresa realized that there were warning signs. “Faith would say to me, ‘Mommy what’s that sound?’ I would say ‘what sound? There was no sound,’ but Faith always insisted that she heard something. Faith was also experiencing headaches and fevers.”
Faith went through a third surgery in June of 2008, this time with a different company. The recovery was painful since there was a build-up of scar tissue that had to be cut through and Faith had a lot of neck pain. “Faith is doing very well with her current implant,” said Theresa, “but she has had to relearn many things. Everything sounded different in the beginning and she had to relearn how things sounded because it was so different with this implant.”
Theresa is frustrated and angry at the experience that her family has been through in the last several years. “I believe having a cochlear implant is worth it and I would do it again, even knowing everything I had gone through, said Theresa. “If I could do it again would I pick the same company—no. I don’t want parents to think that a cochlear implant is something that isn’t beneficial, for the cochlear implant is a great technology. I want parents to know how angry I feel that I trusted a company for my daughter’s quality of life—I trusted them to give her quality of life—and they failed. Having a cochlear implant should not be this kind of experience. “
The Williams Family
Katie Williams was four when she received her first implant. “My wife and I were very excited about getting the cochlear implant,” said Kevin, Katie’s father. “At first, we had good results-- but after six months we noticed that she was having a hard time speaking new words and wasn’t keeping up like the other kids in her class who also had cochlear implants.”
The Williams faced weekly visits to the audiologist to try and determine what might be wrong. “At first, we didn’t think it was the implant,” Kevin explained. A week after the surgery, the Williams received a letter from Advanced Bionics notifying them of a recall. “When we got the recall letter it didn’t say that my daughter had the recalled unit, the letter was about pulling the implants off the shelf,” said Kevin. “I didn’t realize my daughter’s implant was part of the recall, the letter seemed so general. Nothing was said that my daughter had the suspected unit in the recall. So when we started seeing the problem I didn’t think of the recall. We thought it was something else. We were looking for other things and not realizing it was the implant itself.”
For the next two years, the Williams family struggled to understand Katie’s lack of progress. During this time period, the Advanced Bionics representative who tested Katie’s equipment told them that other than some electrodes which had not worked from the beginning, Katie’s implant was functioning as it should. It got to the point where Katie refused to wear her implant and often tried to hide it. Finally their surgeon suggested reimplantation. When the device was removed, it was found to be a defective Vendor B implant with containing 25% moisture/water.
Looking back, Kevin found himself angry at the amount of time that was lost for his daughter and the many trips that his family encountered while trying to determine the cause of the failure. “I’m angry about the letter because it was too general, it was not specific enough,” Kevin explained. “We spent so much time with therapists, and the audiologist going back and forth. Several times my daughter told us that her head hurt and where the magnet was, she experienced pain. We all thought it was related to Katie’s personality—that she didn’t want to wear the implant. So many times I look back and I can’t believe that I wasn’t listening enough to my daughter.”
Kevin believes that parents would benefit from a neutral source of information where parents could find information about each implant company, the recalls and any relevant lawsuits that are public information. “We need something for the parents, other than the marketing that’s out there that’s all positive; it’s hard for parents to know about recalls and on-going problems.” ~