Teresa Curtin is a New York City attorney whose offices are right on Broadway; her specialization: defective drugs and medical devices. It’s no surprise then that families involved in a surge of Advanced Bionics cochlear implant “soft failures” found a champion for their cause in this tenacious, personable powerhouse who just happens to be Deaf and a very satisfied CI user herself.
After graduating from Princeton, I worked at deaf schools before realizing that I wanted to go to law school. I currently practice mainly plaintiffs’ defective drug and defective medical device law at a national level—which I find fascinating. I believe defective drug and medical device cases play an important role in keeping products safe by identifying safety issues. I also have been involved in much deafness-related litigation, including class action lawsuits related to the rights of hearing-impaired prisoners in custody of state and federal correctional facilities and the rights of deaf persons accused of a crime to access to legal services in a language they can understand. I am also very interested the rights of deaf children to equal access to education and linguistic opportunities. As a parent of a special needs child, I know how overwhelming acting as a school advocate for your child can be.
Believe it or not, the idea that the internal part of my device might fail never even occurred to me. In my wildest dreams, I never dreamed that I would be involved in a litigation involving a device my own head. My experience with my CI has been positive. Believe it or not, I have had the same cochlear implant for 24 years—close to half of my life. While I love ASL and Deaf culture and still identify myself as “Deaf” with a capital D, I am also a runner who rarely runs without with my IPod. A few years ago, I started talking on the telephone with family and friends. I see having a CI as a very complicated thing, but there is no question that my cochlear implant allows me to function more independently in the hearing world. But I love my Deaf world, too, and feel very lucky to have both worlds.
I became involved because I care about people. When friends’ Advanced Bionics (AB) CIs first started failing, I explained to them that there was no such thing as a perfect medical device. It was not until later when I started reading FDA documents that I became alarmed at the number of AB failures I was seeing with both Vendor A and Vendor B “feed-throughs”. I wanted to understand what caused these failures and whether current devices are safe, so I got involved. Day in and day out, I would have parents calling me to say they think their child’s implant might be failing, but that the AB representative said the device passed all tests. I listen to crying parents filled with unbearable guilt and pain that they did not listen to their instinct that something was wrong. I listen to parents struggling with the difficult issues of whether to re-implant another device of the same manufacturer or fight the insurance company to get a different manufacturer’s product. Parents tell me they’re very scared of rocking the boat with their cochlear implant center; worried that if they disagree with the audiologist or physician, they will not be able to get mapping services or the same level of treatment. But most of all from every single parent I hear the same question: where would my child had been in their language development if this had not happened and where will my kid be tomorrow? And what is the long-term emotional impact on children implanted at nine months, 14 months or a year, who cannot remember life without his or her bionic “ears” when at the age three or four, his/her implant fails?” I have met some very articulate preschoolers and elementary school kids with single tracked minds: they want their world right back to where it was when their implant was working, right now.
All medical devices have inherent risks. Any time anyone has surgery serious complications can occur. I have not seen any evidence that ALL cochlear implants are inherently unsafe. Sadly, I see the Advanced Bionics Vendor B cases being used by the anti-cochlear implant groups to argue all cochlear implants are inherently unsafe, whereas the pro-cochlear implant groups seem to ignore these failures. I think this has resulted in important questions not being asked by both groups about the FDA oversight of hard and soft failures, and why AB defective devices were allowed to be sold for such a long period of time without the failures being detected. Advanced Bionics admits that 4,010 AB implants have the potentially defective feed-thru. Also, I think all manufacturers need to give more background on how they arrive at their cumulative survival rates (“CSRs”) including whether failed devices that are not explanted are reported as failures.
While I don’t agree with everything this article stated, a recent John Hopkins study (Author’s Note: Revision Cochlear Implant Surgery in Children: The John Hopkins Experience, Otology & Neurology 31:74-82 (2009)) found that the biggest factor in predicting a soft failure in kids is a decline in performance. If a child was doing well with an implant and then a sudden or gradual marked decline in performance occurs, this should be considered a warning sign. Other warning signs include a child’s refusing to wear an implant, complaining of hearing phantom sounds not coming from his or her environment (often described as bubbles or popping), complaining of sudden changes in loudness or softness without changes to the volume control, reporting intermittent sounds or no sounds at all, or reporting pain or headaches. Successive electrodes being turned off may be another symptom. I have had many clients complain about a much shorter battery life and about an increase in behavioral problems (especially with boys).
Families need to be aware that not every device malfunction is a failure. Many other far more common reasons exist why a user might be having a problem with his/her CI. In addition, parents have to be aware that not every child will succeed with a cochlear implant. Device failure is not always the source of the problem. On the other hand, the thing I hear over and over again is that families wish that they had trusted their gut feelings and requested their implant be removed earlier. It can be very difficult to find that one went to AV therapy for months—or years—when the child’s device was later found to be defective. Families need to understand that predicting implant failures is an inexact science and that many devices that pass integrity testing are later found to be defective. For example, the same John Hopkins study found that integrity tests were only “moderately predictive” in predicting which devices had failed. If I remember correctly, of a group of eleven (11) suspected soft failures that were later found to be defective on explanation, six had passed integrity testing. So families should be persistent in letting their CI Center know they think there is a problem and carefully document what is going on with their child.
The issue of “soft failures” is a critical topic given what we know about critical language development stages in children. I am glad that Hands & Voices is addressing it.
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